First 3D-Printed Drug Gets FDA Nod

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

Spirtam is manufactured using 3-dimensional (3D) printing technology, in which thin layers of powdered medication are spread on top of one another and bonded together by patterns of an aqueous fluid. Although 3D printing has been previously used to make medical devices, Spirtam is the first drug crafted by this technology to receive the FDA’s nod.

As a result of the 3D printing process, Spirtam has a unique porous structure that allows even high strengths of the drug to be quickly dissolved with a sip of liquid. This quality could prove highly beneficial to epileptic patients, many of whom have difficulty swallowing pills.

“By combining 3D [printing] technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience,” said Aprecia CEO Don Wetherhold in a press release.

The most common adverse events associated with the use of Spritam include sleepiness, weakness, dizziness, and infection. Additional side effects observed in children treated with the drug include tiredness, aggressive behavior, nasal congestion, decreased appetite, and irritability.

Aprecia plans to launch Spritam in the first quarter of 2016, according to a manufacturer press release.