FDA approves Spritam Zipdose (levetiracetam) for epilepsy-Aprecia Pharmaceuticals

The FDA has approved Spritam (levetiracetam), from Aprecia Pharmaceuticals, for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy. Spritam Zipdose utilises Aprecia's proprietary ZipDose Technology platform that uses three-dimensional printing to produce a porous formulation that rapidly disintegrates with a sip of liquid.

In clinical trials, the most common side effects (incidence ≥5% more than placebo) seen in people who take Spritam include sleepiness, weakness, dizziness, and infection. In addition to those previously listed, the most common side effects seen in children who take Spritam include tiredness, aggressiveness, nasal congestion, decreased appetite, and irritability. Spritam is expected to be available in the USA in the first quarter of 2016.