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FDA approves a drug manufactured using 3D printing

Reporter: Aviva Lev-Ari, PhD, RN

You might be familiar with the concept of 3D-printed medical equipment, but you’re going to have to get used to seeing 3D-printed medicine, too. The US Food and Drug Administration has approved its first drug manufactured using 3D printing, Aprecia’s epilepsy-fighting Spritam. The medication uses a porous, 3D-printed formula to help deliver even very high doses (as high as 1,000mg) while remaining easy to swallow — all you have to do is take a sip of liquid to quickly disperse the drug and get it into your body.

Spritam won’t be available until the first quarter of 2016, and then only by prescription. If it takes off, though, it could do a lot to help patients of all kinds deal with unpleasant medicine. Some kids, seniors and people with swallowing problems may skip doses if they think it’s too difficult to gulp down a pill — Aprecia’s 3D-printed tech should soften the blow. That, in turn, could prevent potentially dangerous lapses in treatment.

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http://www.engadget.com/2015/08/03/fda-approves-3d-printed-drug/

BLUE ASH, Ohio, August 3, 2015 – Aprecia Pharmaceuticals Company today announced that the U.S. Food and Drug Administration (FDA) has approved SPRITAM® levetiracetam for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. 1 SPRITAM utilizes Aprecia’s proprietary ZipDose® Technology platform, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. 1 While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.

“By combining 3DP technology with a highly-prescribed epilepsy treatment,2 SPRITAM is designed to fill a need for patients who struggle with their current medication experience,” said Don Wetherhold, Chief Executive Officer of Aprecia. “This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.”

About Aprecia

Aprecia is an emerging pharmaceutical company that uses proprietary ZipDose Technology to transform the way people take medicine. Aprecia is the first and only company in the world to utilize three-dimensional printing (3DP) technology to develop and manufacture pharmaceutical products at commercial scale. Aprecia plans to introduce multiple new products utilizing ZipDose Technology in the coming years, focusing first on the central nervous system therapeutic area, where there is a need for medicines that are easy to take. The company is privately owned, with Prasco Laboratories and its parent company, Scion Companies, holding controlling interest. For more information visit http://www.aprecia.com.

https://www.aprecia.com/pdf/2015_08_03_Spritam_FDA_Approval_Press_Release.pdf

SOURCE

https://www.aprecia.com/pdf/2015_08_03_Spritam_FDA_Approval_Press_Release.pdf

http://www.engadget.com/2015/08/03/fda-approves-3d-printed-drug/

http://www.theguardian.com/science/2015/aug/04/fda-first-prescription-drug-3d-printing