Feeds:
Posts
Comments

Posts Tagged ‘Medical food’

Additional Data Analysis Demonstrate IBgard Delivered Symptom Reduction in Largest and Most Dissatisfied Group of Irritable Bowel Syndrome Patients

Posted in Uncategorized, tagged , , , , , , on May 10, 2017| Leave a Comment »

Severe IBS Symptoms: Clinical Trial results on delivery of peppermint oil to the small intestine through a system (IBgard®)

https://pharmaceuticalintelligence.com/2015/07/08/severe-ibs-symptoms-clinical-trial-results-on-delivery-of-peppermint-oil-to-the-small-intestine-through-a-system-ibgard/

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 5/10/2017 

Reporter: Gail S. Thornton, MA

Additional Data Analysis from an IBS (Irritable Bowel Syndrome) Clinical Trial Demonstrate IBgard® Delivered Unprecedented Symptom Reduction in the Largest and Most Dissatisfied Group of IBS Patients  

  • Groundbreaking clinical results presented in Chicago at the world’s premier gastroenterology meeting, Digestive Disease Week (DDW), show dramatic symptom reduction among IBS-M (mixed diarrhea and constipation) patients, who experience a high burden in terms of symptoms and quality of life
  • Patients with IBS-M are the most challenging and difficult to diagnose and manage
  • Additional data analysis of only IBS-M patients showed IBgard®, compared to placebo, significantly reduced Total IBS Symptom Score (TISS) and showed favorable effects on all 8 measured individual IBS symptoms, including constipation, diarrhea and abdominal pain

 

CHICAGO – (May 10, 2017) –  The more recent scientific understanding of Irritable Bowel Syndrome (IBS) having multiple causes, including reversible, low-grade inflammation, resulting in abdominal pain, constipation and/or diarrhea in some patients, received further support during Digestive Disease Week (DDW). This is the premier annual meeting of gastroenterologists in Chicago and this subject was discussed on May 9, 2017.

Brooks D. Cash, M.D., A.G.A.F., Professor of Medicine at the University of South Alabama in Mobile, Ala., and Chief of the USA Gastroenterology Division, was the lead presenter of an additional clinical analysis of the IBSREST™ study, a randomized clinical trial (RCT) previously presented at DDW, where IBgard® showed significant efficacy in a combined group of IBS-M (mixed diarrhea and constipation) and IBS-D (diarrhea predominant) patients at 24 hours and at 4 weeks.

Additional analysis of only the IBS-M patients in IBSREST™ demonstrated that there was a statistically significant reduction vs. placebo in the Total IBS Symptom Score (TISS) at 4 weeks. TISS is a composite score of the eight individual IBS symptoms. When evaluating the individual symptoms at 4 weeks, there was a favorable reduction on both major types of bowel dysfunction (diarrhea and constipation) and favorable reduction in viscerosensory symptoms, including abdominal pain and other IBS symptoms.

IBS-M is a challenging and difficult to diagnose and treat sub-type of IBS and represents an area of high unmet need. Most individuals with IBS (74 percent of those medically diagnosed and 63 percent not medically diagnosed) reported variable symptoms of constipation and diarrhea.[1]  There are no FDA-approved interventions for IBS-M.

It has been posited that l-Menthol, the principal component found in IBgard®, works via several different mechanisms of action in the gut, including exerting anti-inflammatory, smooth muscle relaxing and anti-nociceptive effects. Immune-activated gut barrier disturbance in the small intestine is believed to be another possible source of IBS-related altered stool form, as well as abdominal pain and other IBS symptoms.

IBgard® is specially formulated for the dietary management of IBS and is the first product using a patented, breakthrough technology called Site Specific Targeting (SST®) to deliver individually triple-coated, solid-state, sustained release microspheres of Ultramen®, an ultra-purified peppermint oil, quickly and reliably to the small intestine where its actions help manage IBS.

According to Ali Rezaie, M.D., assistant director, Gastrointestinal Motility Program at Cedars-Sinai Medical Center in Los Angeles, “Alternating bowel habits can happen on a daily basis… Intervals between the patterns [IBS-D and IBS-C] can vary widely.” He added, “I have patients who say they have constipation in the morning, and then, by evening, they have loose watery stools. Even with the same bowel movement, some patients may start with hard stool that has to be pushed, and by the end, it will be watery.”[2]

“Over the last several years, we in the gastroenterology community have tended to bracket IBgard® as an anti-spasmodic for IBS-D, similar to prescription antispasmodics, but with minimal side effects,” said Dr. Cash. “The current findings raise the possibility that there may be broader clinical applications for IBgard® in reducing IBS-M symptoms as well. This is an important observation that needs further research in terms of the most important mechanisms of action of l-Menthol.”

“We are gaining a great understanding of the underlying causation of IBS,” said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience®, the innovators of IBgard®. “The largest and most dissatisfied group of IBS patients should start seeing the benefit of recent advances in IBS science.”

Gut Mucosal Barrier Dysfunction Is Key Factor in IBS

As a complex and multifactorial disorder, IBS involves several factors that interact in the body to produce, at various times, digestive tract symptoms, including constipation, diarrhea, bloating, abdominal pain and discomfort.

As new diagnostic tools help advance science in gastrointestinal disorders, gut mucosal barrier dysfunction associated with reversible and low-grade inflammation is now becoming better accepted as a root cause.

Overview of Clinical Sub-Analysis of IBS-M in IBSREST™ RCT

As mentioned earlier, the IBSREST™ RCT had already shown favorable results in a combined group of IBS-D and IBS-M patients.

In view of the unmet need in IBS-M, researchers performed an additional analysis to test the efficacy of IBgard® in patients with IBS-M in the IBSREST™ study. The analysis showed that in the composite score of all eight symptoms measured, IBgard® demonstrated a significant reduction vs. placebo. It also showed favorable results in individual IBS symptoms, including diarrhea and constipation, where it showed significance (P=0.0085) despite the smaller sample size.

More specifically, the analysis of IBS-M patients in the IBSREST™ study showed that after four weeks of daily intake of IBgard®, patients experienced the following:

Reduction in Total IBS Symptom Score (TISS):

  • 3% reduction of Total IBS Symptom Score (TISS) from baseline. Statistically significant compared to placebo (P=0.0298).
  • 1% reduction in frequency of IBS symptoms from baseline. Statistically significant compared to placebo (P=0.0349).
  • 2% reduction in intensity of IBS symptoms from baseline. Near significance compared to placebo (P=0.0528).

Reduction in Overall Constipation Score:

  • 1% reduction in overall constipation symptoms from baseline. Statistically significant compared to placebo (P=0.0085).
  • 3% reduction in frequency of constipation from baseline. Statistically significant compared to placebo (P=0.0137).
  • 64% reduction in intensity of constipation from baseline. Statistically significant compared to placebo (P=0.0221).

 

Reduction across the Syndrome of Symptoms (abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus):

  • Greater reduction in all eight symptoms of IBS comprising the TISS, compared to placebo, with significance reached in abdominal pain (P=0.0426), constipation (P=0.0085), urgency (P=0.0364), and sense of incomplete evacuation (P=0.0422).
  • The largest reduction was seen with constipation versus placebo (P=0.0085).
  • Numerical reduction versus placebo in both constipation (P=0.0085) and diarrhea (P=0.2296) in IBS-M.
  • Pain at evacuation was numerically superior (P=0.0720).

IBSREST™ Study Design

To qualify for entry in the IBSREST™ study, the participants had to meet Rome III criteria for IBS-M. They had to have average daily IBS-related abdominal pain of ≥ 4 on a 0-10 scale, and a TISS of ≥ 2 on a 0-4 scale.

In the study, there were 34 IBS-M participants, 16 who received IBgard® and 18 who received placebo. Study participants were randomly allocated to receive IBgard® 180 mg TID or identical placebo for four weeks. Primary analysis was based on the TISS score. Additional assessments included change from baseline in frequency and intensity of individual IBS symptoms.

About Irritable Bowel Syndrome
One in six Americans experience Irritable Bowel Syndrome (IBS), a frustrating, under-diagnosed and under-treated condition characterized by recurrent abdominal pain, often associated with alteration in stool frequency and/or form. Bloating is also a common symptom experienced by patients with IBS. Recent understanding regarding the multiple etiologies of IBS point to gut mucosal barrier dysfunction associated with reversible, low-grade inflammation as a potential contributor to abdominal pain and altered stool form symptoms of IBS.

About IBgard®  

IBgard® is a medical food specially formulated for the dietary management of IBS. IBgard® capsules contain solid state microspheres of peppermint oil, including its principal component l-Menthol, plus fiber and amino acids (from gelatin protein), in a unique delivery system.

With its patented Site Specific Targeting (SST®) technology, pioneered by IM HealthScience®, IBgard® capsules release Ultramen®, an ultra-purified peppermint oil, quickly and reliably to the small intestine, where its actions help manage IBS. The food nutrients in IBgard® (peppermint oil along with fiber and amino acids) may help reduce the low-grade, reversible inflammation found in some IBS and help normalize gut mucosal barrier function. Additionally, peppermint oil has also been shown to help normalize intestinal transit time.

IBgard® was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial called the Irritable Bowel Syndrome Reduction Evaluation and Safety Trial™ (IBSREST).  Patients suffering from IBS-M and IBS-D were included in the study. The study findings were accepted and published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peer-reviewed scientific journal. The data showed that IBgard® demonstrated a statistically significant reduction in the Total IBS Symptom Score (TISS) in as early as 24 hours and at four weeks. The TISS represents a composite score of eight individual IBS symptoms. Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during flare-ups.

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard® for their patients. In a recent nationwide survey of gastroenterologists, IBgard® is the number one recommended peppermint oil for IBS among gastroenterologists for the second consecutive year by an overwhelming margin. Like all medical foods, IBgard® does not require a prescription, but it must be used under medical supervision. Only doctors can diagnose IBS. The usual adult dose of IBgard® is 1-2 capsules as needed, up to three times a day, not to exceed 8 capsules per day.

IBgard® is available to patients in the digestive aisle at most Walmart, CVS/pharmacy, Walgreens and Rite Aid stores nationwide as well as in independent drug stores and grocery stores across the country.

About IM HealthScience®

IM HealthScience® (IMH) is the innovator of IBgard® for the dietary management of irritable bowel syndrome. It is a privately held company based in Boca Raton, Florida, that is also the innovator of FDgard® for the dietary management of functional dyspepsia. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address gastrointestinal issues where there is a high unmet need. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com or www.FDgard.com.

Data Presented at DDW Poster Session on Irritable Bowel Syndrome

Tuesday, May 9, 2017

  • (Poster Session #Tu1601) In Patients with Irritable Bowel Syndrome-Mixed (IBS-M), a Novel Peppermint Oil Formulation Designed for Site Specific Targeting (PO-SST), in the Small Intestine, Improves the 8 Symptoms that Comprise the Total IBS Symptoms Score (TISS). 
    • Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah
  •  (Poster Session #Tu1600) Patient Responder Analysis for a Total IBS Symptom Score (TISS) and Abdominal Pain with a Novel Peppermint Oil Site Specific Targeting (PO-SST) Formulation from the US-based IBSREST Randomized Controlled Trial
    • Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah

For more information about featured studies, as well as a schedule of availability for featured researchers, please visit www.ddw.org/press.

About Digestive Disease Week® (DDW)

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 6-9, 2017, at McCormick Place, Chicago, IL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

Regulation of Medical Foods

IBgard® is a medical food product and not a drug or dietary supplement.  A medical food is defined by section 5(b)(3) of the Orphan Drug Act (21 U.S.C, 360ee (b)(3) as a “food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinct nutritional requirements, based on scientific principles, are established by medical evaluation.” Medical foods do not require prior approval by the FDA and are in a unique category separate from drugs or dietary supplements. Medical foods must contain ingredients that are “Generally Recognized As Safe” (GRAS), or are approved food additives, as defined under sections 201(s) and 409 of the Federal Food, Drug and Cosmetic Act.

REFERENCE/SOURCE

[1] Hungin, A.P.S., Chang, L., Locke, G.R., Dennis, E.H. & Barghout, V. (2005, June 2). Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Alimentary Pharmacology and Therapeutics, 21 (11): 1365-1375.  doi: 10.1111/j.1365-2036.2005.02463.x.

[2] Swift, D. & Bilal, M. (2016, December 15). IBS Purgatory: Mixed Irritable Bowel Syndrome – Symptoms can fluctuate rapidly, and psychological burden is onerous. Retrieved from http://www.medpagetoday.com/reading-room/aga/lower-gi/62101.

SOURCE

http://www.prnewswire.com/news-releases/additional-data-analysis-from-an-ibs-irritable-bowel-syndrome-clinical-trial-demonstrate-ibgard-delivered-unprecedented-symptom-reduction-in-the-largest-and-most-dissatisfied-group-of-ibs-patients-300454295.html

Read Full Post »

Results of New Clinical Data Presented at Digestive Week (DDW), Symptom Reduction and Rapid Pain Relief of Functional Dyspepsia with FDgard®

Posted in Biochemical pathways, Gastroenterology, tagged , , , , on May 8, 2017| Leave a Comment »

Results of New Clinical Data Presented at Digestive Week (DDW), Symptom Reduction and Rapid Pain Relief of Functional Dyspepsia with FDgard®

Reporter: Gail S. Thornton, MA

 

RESULTS OF NEW CLINICAL DATA PRESENTED AT DIGESTIVE DISEASE WEEK (DDW), A PREMIER GASTROENTEROLOGY MEETING, SHOW UNPRECEDENTED SYMPTOM REDUCTION AND RAPID RELIEF OF FUNCTIONAL DYSPEPSIA (FD – PERSISTENT OR RECURRING INDIGESTION) WITH FDgard®, A NEW PRODUCT FOR THIS CONDITION

 First-ever clinical study highlights an advance in the management of Functional Dyspepsia (FD) with FDgard®, a new, non-prescription medical food specially formulated for the dietary management of FD

  • In FD patients, FDgard® significantly reduced symptoms of FD in as early as 24 hours
  • Data showed FDgard®, as an add-on product, improved FD symptoms in patients already using commonly used, off-label medications prescribed for FD
  • Functional Dyspepsia, known for its symptoms of persistent or recurring indigestion, impacts an estimated 1 in 6 adults in the U.S.
  • This medical advance is important because there are no approved products for FD

 CHICAGO – (May 8, 2017) – Landmark clinical data highlight an advance in the management of Functional Dyspepsia (FD) with FDgard®, the only product available for the dietary management of FD. FDgard® demonstrated unprecedented symptom reduction and rapid relief of FD symptoms in patients in only 24 hours. This data was presented during Digestive Disease Week (DDW), a premier gastroenterology meeting.

FDgard® showed effective symptom reduction and rapid relief of FD symptoms in a sub-group of FD patients with Epigastric Pain Syndrome (EPS, which is epigastric pain or burning) and Postprandial Distress Syndrome (PDS, which is early fullness, pressure and heaviness). Additionally, the study findings showed that FDgard® as an add-on product improved FD symptoms in patients already using commonly used, off-label medications prescribed for FD, such as proton pump inhibitors (PPIs) and histamine receptor 2 antagonists (H2RAs), anticonvulsants, antibiotics, antihistamines, antidepressants, and antacids as rescue medications (permitted no more than three doses per week).

FD is often characterized as persistent or recurring indigestion with no known organic cause and is an area of high unmet medical need. Currently, off-label medications are used to treat FD as there is no U.S. Food and Drug Administration (FDA)-approved pharmaceutical product for the condition.

Data from the landmark, multi-centered, post-marketing, parallel group, U.S-based study, entitled FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial), showed that patients with FD who received FDgard® versus a control arm of placebo plus commonly used, off-label FD medications experienced a statistically significant reduction in Postprandial Distress Syndrome (PDS) symptoms and near statistical significance in Epigastric Pain Syndrome (EPS) symptoms at 24 hours. In spite of the polypharmacy and use of rescue medications after 48 hours of first dose, FDgard® helped further improve symptoms at 4 weeks.

Specifically, the FDREST™ study showed that at 24 hours, FDgard® improved FD symptoms in patients and provided rapid and significant reduction in EPS and PDS symptoms in the PDS sub-group as well as a statistically significant reduction in EPS and PDS symptoms in the EPS sub-group. At 4 weeks, approximately 75 percent of the EPS and PDS patients in the FDgard® arm reported substantial symptom improvement vs. approximately half in the control arm.

An estimated 62 percent of FD patients suffer from EPS, while an estimated 73 percent of FD patients suffer from PDS. The overlap of EPS and PDS, which are those FD patients who suffer from both syndromes, is estimated to be 35 percent.[1]

FDgard® is specially formulated for the dietary management of FD, which is persistent or recurring indigestion. It is the first product using a patented, breakthrough technology called Site Specific Targeting (SST®) to deliver individually triple-coated, solid-state microspheres of caraway oil and l-Menthol, the primary component in peppermint oil, quickly and reliably where they are needed most in FD — the upper belly.

The three posters with data from the FDREST™ study were selected for presentation at DDW on Saturday, May 6, 2017.

“These study results are uniquely important and represent an advance in the management of Functional Dyspepsia,” said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience®. “We believe that FDgard® possesses anti-inflammatory, analgesic, and gastro-protective properties, which likely are responsible for the rapid relief and steady improvement of FD symptoms in patients even when used as an add-on therapy to commonly used, off-label medications to treat FD, as demonstrated in the FDREST™ study. In particular, many FD symptoms flare within 2 hours after a meal, so the fast action seen in this FDgard® study is an important advance.”

 

FDREST™ Results

“Functional dyspepsia can have a significant impact on a patient’s quality of life,” said

William D. Chey, M.D., F.A.C.G., the lead study author and Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, Michigan. “These study results suggest that FDgard® can provide rapid relief to a subset of patients with functional dyspepsia – a condition for which there are few effective treatments.”

Analysis of FDREST™ data showed that treatment with FDgard® resulted in:

Change in Epigastric Pain Syndrome (EPS) and Postprandial Distress Syndrome (PDS) Symptoms In Overall Participants at 24 hours:

  • 14% improvement of EPS symptoms from baseline at 24 hours. Close to statistical significance compared to the control group (P=0.0737).
  • 9.9% reduction of PDS symptoms from baseline at 24 hours. Statistically significant compared to the control group (P=0.0393).

 

Change in Epigastric Pain Syndrome (EPS) and Postprandial Distress Syndrome (PDS) Symptoms In PDS Group at 24 hours:

  • 19.5% reduction of EPS symptoms from baseline at 24 hours. Statistically significant compared to the control group (P=0.0121).
  • 15.8% reduction of PDS symptoms from baseline at 24 hours. Statistically significant compared to the control group (P=0.0225).

 

Change in Epigastric Pain Syndrome (EPS) and Postprandial Distress Syndrome (PDS) Symptoms In EPS Group at 24 hours:

  • 20.7% reduction of EPS symptoms from baseline at 24 hours. Statistically significant compared to the control group (P=0.0028).
  • 13.2% reduction of PDS symptoms from baseline at 24 hours. Statistically significant compared to the control (P=0.0186).

 

Change in the Clinical Global Impressions Scale (CGI, a measure of symptom severity, treatment response and treatment efficacy):

  • At the end of treatment, 77.7% of PDS patients and 72.2% of EPS patients reported either a “much” or “very much” improved assessment of the Clinical Global Impressions (CGI) scale, compared to 50% (P=0.09) and 40% (P=0.046) in the control groups, respectively.
  • EPS patients had a statistically significant reduction in epigastric pain or discomfort symptoms at 24 hours and were objectively better, although measures did not reach statistical significance, compared to the control group, in all measures at 2-14 days and 15-28 days.
  • PDS patients had a statistically significant reduction in sensations of pressure, heaviness, or fullness compared with the control group at 24 hours and were objectively better, although measures did not reach statistical significance, compared to the control group, in all measures at 2-14 days and 15-28 days.

 

Study Design

FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial) was a multi-centered, post-marketing, parallel group, U.S-based study conducted at eight university-based or gastroenterology research-based centers in the U.S. (study period July 1, 2015, to September 14, 2016). The study was designed to compare the efficacy and safety of FDgard®, plus commonly used FD medications vs a control group of placebo plus commonly used, off-label medications prescribed for FD.

  • There were 100 study participants (76% female; 24% male), aged 18-60 (mean age 43.4 years), with symptoms of FD, all of whom met Rome III criteria for FD.
  • They were selected if they met one or both of the following criteria, based on symptoms:
    • Postprandial Distress Syndrome (PDS, early fullness, pressure and heaviness) – Bothersome postprandial fullness or early satiation at least 3 days per week
    • Epigastric Distress Syndrome (EPS, epigastric pain or burning) – Bothersome epigastric pain or burning at least 1 day per week.
  • They had to have at least moderate symptoms (≥4 points on either question of the 7-point Global Overall Symptoms (GOS) scale on at least 4 days during a 14-day screening period. The GOS scale is a self-reported 7-point scale, adapted from a previously validated 5-point scale. With this scale, patients are asked to grade the overall severity of their dyspepsia symptoms, as defined as upper abdominal symptoms over a certain period of time.
  • The study also showed an improvement at 4 weeks in the Clinical Global Impressions (CGI) Scale, a physician-administered measure of symptom severity, treatment response and treatment efficacy.
  • In the trial, study participants took two capsules of FDgard® or matching placebo in the morning and at dinner time 30 to 60 minutes before a meal. FDgard® or placebo was added to each patients existing FD medication regimen, which included proton pump inhibitors (PPIs), histamine receptor 2 antagonists (H2RAs), anticonvulsants, beta blockers, antihistamines, antidepressants/tricyclic antidepressants (TCAs), pain modulators, antacids, and/or antibiotics. In addition, rescue medications (including prokinetics, antiemetics, anticholinergics, laxatives, antidiarrheals, misoprostol, oral antibiotics, probiotics, calcium channel antagonists, NSAIDs, aspirin (>81 mg per day), antispasmodics, narcotic analgesics, sedative hypnotic agents and other medications that may affect the study) were allowed 48 hours after the first dose, if approved by the medical monitor.
  • Over the course of the study, no serious treatment-emergent adverse events were reported.

 

About Functional Dyspepsia (FD)

Approximately 30 percent of adults suffer from dyspepsia, and about half are estimated to have FD, or non-ulcer dyspepsia.[2] This condition can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.[3]

In FD, which is persistent or recurring indigestion, the normal digestive processes are disrupted along with the digestion and absorption of food nutrients. FD is accompanied by symptoms, such as epigastric pain or discomfort, epigastric burning, postprandial fullness, early satiation, bloating in the upper abdomen, nausea and belching. When doctors diagnose FD, they often identify patients as follows: patients should have these symptoms for at least three months with symptom onset six months previously.

 About FDgard® 

FDgard® is medical food designed to address an unmet medical need for products to help in managing FD, which is persistent or recurring indigestion and its accompanying symptoms.  FDgard® capsules contain caraway oil and l-Menthol, the primary component in peppermint oil, for the dietary management of Functional Dyspepsia (FD). With its patented Site Specific Targeting (SST®) technology, pioneered by IM HealthScience®, FDgard® capsules release individually triple-coated, solid-state microspheres of caraway oil and l-Menthol quickly and reliably where they are needed most in FD — the upper belly. The l-Menthol helps with smooth muscle relaxation and caraway oil helps mitigate the effect of gastric acid on the stomach wall and also helps to normalize gallbladder function as well as deliver promotility and analgesic action in the small intestine (the duodenum) and the stomach.[4] [5] [6] In addition to caraway oil and l-Menthol, FDgard® also provides fiber and amino acids (from gelatin protein). These ingredients have additional positive effects on the gut wall and, thus, help toward normalizing digestion and absorption.

Caraway oil and peppermint oil have a history of working in FD. In multiple clinical studies, the combination of caraway oil and peppermint oil has been shown to manage FD and its accompanying symptoms, such as reducing the intensity of epigastric pain, pain frequency, dyspeptic discomfort and reducing the intensity of sensations of pressure, abdominal heaviness and fullness…significantly better than placebo. A randomized, placebo-controlled multicenter study in Europe[7], previously conducted with the same endpoints and measurements as used in FDREST™, had shown the effectiveness of caraway oil and peppermint oil (l-Menthol) in managing FD symptoms. This study was rated as the highest-quality study on the Jadad scale with a rating of 5, which independently assesses the methodological quality of a clinical trial, and is the most widely used assessment in the world.  The study had used the older single-unit, oil-filled capsule technology, which has challenges in rapid and targeted delivery. Targeted delivery to the upper belly is desirable as recent studies have identified this as the area of disturbance in FD. With SST®, it has now become possible to deliver the combination of caraway oil and peppermint oil (l-Menthol) to this site.

The usual adult dose of FDgard® is 2 capsules, as needed, up to two times a day, not to exceed six capsules per day. While FDgard® does not require a prescription, it must be used under medical supervision, since it is a medical food. FDgard® is available to patients in the digestive aisle at most Rite Aid, CVS/pharmacy and Walgreens stores nationwide.

 

About IM HealthScience®

IM HealthScience® (IMH) is the innovator of IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. It is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address gastrointestinal issues where there is a high unmet need. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com or www.FDgard.com.

 

Data Presented at DDW Poster Session on Functional Dyspepsia, Nausea and Vomiting

Saturday, May 6, 2017

  • (Poster Session #Sa1618) Randomized Controlled Trial to Assess the Efficacy & Safety of Caraway Oil/L-Menthol plus Usual Care Polypharmacy vs. Placebo plus Usual Care Polypharmacy for Functional Dyspepsia 
    • Dr. William Chey, Dr. Brian Lacy, Dr. Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah
  •  (Poster Session #Sa1620) A caraway oil/menthol combination improves functional dyspepsia (FD) symptoms within the first 24 hours: Results of a randomized controlled trial, which allowed usual FD treatments
    • Dr. Brian Lacy, Dr. William Chey, Dr. Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah
  •  (Poster Session #Sa1619) Efficacy of caraway oil/L-menthol plus usual care vs placebo plus usual care, in functional dyspepsia patients with post-prandial distress (PDS) or epigastric pain (EPS) syndromes: Results from a US RCT
    • Dr. William Chey, Dr. Brian Lacy, Dr. Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah

For more information about featured studies, as well as a schedule of availability for featured researchers, please visit www.ddw.org/press.

About Digestive Disease Week® (DDW)

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 6-9, 2017, at McCormick Place, Chicago, IL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

Regulation of Medical Foods

FDgard® is a medical food product and not a drug or dietary supplement.  A medical food is defined by section 5(b)(3) of the Orphan Drug Act (21 U.S.C, 360ee (b)(3) as a “food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinct nutritional requirements, based on scientific principles, are established by medical evaluation.” Medical foods do not require prior approval by the FDA and are in a unique category separate from drugs or dietary supplements. Medical foods must contain ingredients that are “Generally Recognized As Safe” (GRAS), or are approved food additives, as defined under sections 201(s) and 409 of the Federal Food, Drug and Cosmetic Act.

###

REFERENCE/SOURCE

[1] Talley, N.J. & Ford, A.C. (2015). Functional Dyspepsia. The New England Journal of Medicine, 373, 1853-63. doi: 10.1056/NEJMra1501505.

[2] Copyright © 1997 International Foundation for Functional Gastrointestinal Disorders (IFFGD). All rights reserved. Functional Dyspepsia and IBS: Incidence and Characteristics.

[3] Lacy, B.E., Weiser, K.T., Kennedy, A.T., Crowell, M.D., & Talley, N.J. (2013). Functional dyspepsia: the economic impact to patients. Alimentary Pharmacology & Therapeutics, 38:170-177. doi: 10.111/apt.12355.

[4] Shams, R., Oldfield, E.C., Copare, J., & Johnson, D.A. (2015). Peppermint Oil: Clinical Uses in the Treatment of Gastrointestinal Diseases. JSM Gastroenterology and Hepatology, 3 (1): 1035-1046.

[5] Sun, J. (2007). D-Limonene: Safety & Clinical Applications. Alternative Medicine Review, 12 (3): 259-264.

[6] Goncalves, J.C.R., Alves, A. de Miranda H., de Araujo, A.E.V., Cruz, J.S., & Araujo, D.A.M. (2010). Distinct effects of carvone analogues on the isolated nerve of rats. European Journal of Pharmacology, 645:108-112. doi: 10.1016/j.ejphar.2010.07.027.

[7] May, B., Köhler, S., & Schneider, B. (2000). Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Alimentary Pharmacology and Therapeutics, 14 (12), 1671–1677. doi: 10.1046/j.1365-2036.2000.00873.x.

SOURCE

http://www.prnewswire.com/news-releases/results-of-new-clinical-data-presented-at-digestive-disease-week-ddw-a-premier-gastroenterology-meeting-show-unprecedented-symptom-reduction-and-rapid-relief-of-functional-dyspepsia-fd—persistent-or-recurring-indigestion-w-300452368.html

Read Full Post »

%d bloggers like this: