Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Pharmacotherapy for Opioids

Larry H. Bernstein, MD, FCAP, Curator

LPBI

Opioid-Dependence Implant: A New Treatment for Opioid Addiction

http://www.pharmpro.com/news/2016/01/opioid-dependence-implant-new-treatment-opioid-addiction

Probuphine is a small rod that contains the medication buprenorphine, which was approved by the FDA for opioid addiction in 2002. Developed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, the rod is placed under the skin (usually in the upper arm) by a doctor in an office procedure. One implant provides patients with 6 months of continuous buprenorphine dosing.

By binding opioid receptors in the body, buprenorphine can:

• Prevents physical withdrawal from opiates
• Limit cravings for opiates
• Block the effects of opiates

Buprenorphine is often taken in combination with a medication called naloxone. Acting as an antidote for overdoses, naloxone negates the effect of any additional opiates.

At present, buprenorphine is typically administered orally in daily doses or indissolvable strips.

On January 12, the FDA Psychopharmacologic Drugs Advisory Committee voted in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction in stable patients receiving 8 mg or less per day of buprenorphine.

Interestingly enough, however, the same committee previously rejected Probuphine in 2013—requesting new clinical data and additional information before the company could resubmit. The FDA sent a letter to Titan, which detailed recommendations on product labeling and ways to improve the company’s proposed risk evaluation and mitigation strategy for the candidate.

Based on results from the company’s Phase 3 trial of 177 patients in 2015, Titan narrowed the implant’s indication to patients receiving 8 mg or less per day of buprenorphine.

Acknowledging that the implant had advantages compared to other formulations—such as its being difficult to abuse and is less likely to be ingested accidentally by children—the FDA expressed concerns about the implantation and removal, as surgeons must be trained on these procedures.

Other complications to be considered with this new technology are:

• The difficulty in changing a patient’s dosing
• It is not ideal for patients who need a high dose of buprenorphine
• How long a patient should have an implant, as some doctors feel that certain patients need to be on medicine indefinitely

Despite these challenges, the timing of the emergence of Titan’s implant could not be better—as opioid addiction has been deemed as anational epidemic. Since 1999, deaths from prescription painkillers have quadrupled, “killing more than 16,000 people in the U.S. in 2013,” according to the CDC. Even more alarming, theCDC reported that “nearly two million Americans, aged 12 or older, either abused or were dependent on opioids in 2013.”