FDA Approves Rapid Dissolving Epilepsy Drug Produced by 3D Printing

A novel rapidly solubilized drug for treatment of epilepsy has become the first medication manufactured by a three-dimensional (3D) printing technique to be approved by the [US] Food and Drug Administration (Bethesda, MD, USA).

The Aprecia Pharmaceuticals (Langhorne, PA, USA) Spritam formulation of the epilepsy drug levetiracetam was manufactured using a proprietary 3D printing method called ZipDose technology. This process stitches together multiple layers of powdered medication using an aqueous fluid to produce a porous, water-soluble matrix that rapidly disintegrates with a sip of liquid.

Spritam is prescribed for certain epilepsy cases, involving partial-onset seizures, myoclonic, and primary generalized tonic-clonic seizures in both adults and children. In clinical trials, the most common adverse effects in people taking Spritam included sleepiness, weakness, dizziness, and infection. In children, tiredness, aggressive behavior, nasal congestion, decreased appetite, and irritability have also been observed.

"By combining [three-dimensional 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 Don Wetherhold CEO of Aprecia. "This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication."

Related Links:
[US] Food and Drug Administration
Aprecia Pharmaceuticals