- The FDA on Monday crossed a new milestone by approving its first-ever 3D printed drug: Aprecia Pharma's Spritam (levetiracetam), approved for adjunctive treatment of various types of seizures in children and adults with epilepsy.
- Spritam uses Aprecia's ZipDose technology platform in which premeasured doses are created in a porous formulation that disintegrates in the mouth. This platform allows for a very high drug load of up to 1,000 mg in a single dose.
- Aprecia is currently developing other central nervous system (CNS) drugs based on the ZipDose platform.
This is not the first time that 3D printing (3DP) has been used in a healthcare-related capacity. 3DP has been used by dentists to create replicas of jaws, teeth, and implants and as part of medical-device manufacturing. But this is the first time that the tech has been used to create an FDA-approved pharmaceutical.
The major advantage associated with Spritam is ease of use for patients who have difficulty swallowing or for whom adherence is a problem for any number of reasons—this includes children who often don't want to take medications and older people who often have a hard time swallowing. With just a sip of liquid, Spritam dissolves in the mouth immediately.
All told, roughly three million people in the U.S. have been diagnosed with active epilepsy, including 460,000 children. Spritam is expected to be available at some point during the first quarter of 2016.