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FDA Says ‘Yes’ to Levetiracetam (Spritam) for Epilepsy-Related Seizures

First approval of 3D-printed drug product

The FDA has approved levetiracetam (Spritam, Aprecia Pharmaceuticals) for oral use as adjunctive therapy in the treatment of partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and children with epilepsy.

Levetiracetam is manufactured using Aprecia’s proprietary ZipDose technology platform, which employs three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP has been used to manufacture medical devices, the new approval marks the first time a drug product manufactured with this technology has been given the green light by the FDA.

According to Aprecia, ZipDose technology allows the delivery of a high drug load –– up to 1,000 mg in a single dose. Levetiracetam manufactured with ZipDose technology is expected to be available in the U.S. in the first quarter of 2016.

Oral levetiracetam is used with other medications to treat primary generalized tonic-clonic seizures in patients 6 years of age and older with certain types of generalized epilepsy; to treat myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy; and to treat partial-onset seizures in patients 4 years of age and older with epilepsy. The product is recommended for use in patients weighing 20 kg (44 pounds) or more.

In clinical trials, the most common adverse events associated with levetiracetam included sleepiness, weakness, dizziness, and infection. In children, the most common adverse events included tiredness, aggression, nasal congestion, decreased appetite, and irritability.

Nearly 3 million people in the U.S. have been diagnosed with active epilepsy, with an estimated 460,000 of those cases occurring in children.

Source: Aprecia Pharmaceuticals; August 3, 2015.

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