FDA Approves First 3D Printed Tablets
Aprecia announced that the Food and Drug Administration (FDA) has approved Spritam (levetiracetam) tablets as adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in patients with epilepsy. Spritam is the first 3D printed drug product approved by the FDA.
Spritam utilizes ZipDose Technology platform, which produces a porous formulation through 3D printing; this allows the formulation to quickly disintegrate with a sip of liquid. The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. Levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting that levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity.
Spritam will be available as 250mg, 500mg, 750mg, and 1000mg strengths in 60-count cartons (6x10) in a spearmint flavor. It is expected to launch in the first quarter of 2016.
For more information call (844) 882-7732 or visit Spritam.com.