FDA makes its first approval of a 3-D printed drug

For the first time, the FDA has approved a drug produced using a 3D printer. Aprecia Pharmaceuticals picked up the approval and distinction of being first past the post when the FDA gave the all-clear to its adjunctive therapy for the treatment of epilepsy.

The drug, Spritam, is a reworking of UCB's now-off-patent Keppra. Generic versions of the drug have been available since 2008, but Aprecia thinks its computer-aided 3D printing technology can give it an edge over the other copycats, particularly in terms of ease of administration and treatment adherence. Aprecia has used 3D printing tools developed at MIT to build multiple thin layers of the powdered drug interspersed with liquid droplets, resulting in dosage forms that the company claims will disintegrate in a sip of fluid even when loaded with large quantities of the active ingredient.

Such features could appeal to anyone who has difficulty swallowing, and Aprecia will be pitching for this subpopulation when it starts marketing Spritam early next year. In the longer term, Aprecia plans to develop other 3D printing-enabled reworkings of highly prescribed, high-dose drugs. While such new dosage forms could make life easier for patients, some observers think the arrival of 3D printing in commercial drug manufacturing has more far-reaching implications. One barrier to the localization and fragmentation of drug production is now being lowered.

"For the last 50 years we have manufactured tablets in factories and shipped them to hospitals and for the first time this process means we can produce tablets much closer to the patient," Mohamed Albed Alhnan, a pharmaceutics lecturer at the University of Central Lancashire, told BBC News.

- check out the BBC's article
- read Reuters' coverage
- here's LA Times' take
- see the press release (PDF)
- get FierceDrugDelivery's take

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