FDA News, Week of Aug 3, 2015
FDA Approves 3D printed tablets (Aprecia Pharmaceuticals, Blue Ash, OH)
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.
SPRITAM utilizes Aprecia’s proprietary ZipDose® Technology platform, 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.
ZipDose® Technology product candidates are intended to improve the patient experience and help increase adherence by being designed to1:
- Rapidly disintegrate in less than 10 seconds—a previously unachievable rate for high-dose formulations (based on demonstrator development testing)
- Offer a wider range of taste-masking capabilities than were previously possible
FDA Approves DELTOID Injection Site for Abilify Maintena® (aripiprazole) for extended-release injectable suspension in the Treatment of Schizophrenia (Otsuka Pharmaceuticals, Princeton, NJ)
Approval based on data demonstrating comparable pharmacokinetics, tolerability and safety of deltoid vs gluteal administration