Aprecia's Spritam is first 3D-printed drug product approved by FDA

US privately-held specialty company Aprecia Pharmaceuticals says that the US Food and Drug Administration 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, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid d. 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.

Aprecia holds an exclusive, worldwide license from the Massachusetts Institute of Technology (MIT) for pharmaceutical applications of the 3DP technology. Levetiracetam is the active ingredient of Belgian drugmaker UCB’s (Euronext Brussels: UCB) now off-patent epilepsy treatment Keppra.