FDA approves 3D printed drug for epilepsy

The FDA announced it has approved Spritam as an adjunctive therapy for epileptic seizures in children and adults, according to an agency release.

Spritam (levetiracetam), which is manufactured by the Aprecia Pharmaceuticals Company, uses the company’s ZipDose Technology Platform. ZipDose produces a porous formulation using 3D printing that quickly disintegrates with a sip of liquid, according to the release.

“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. 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,” Don Wetherhold, CEO, Aprecia, said in the release.

Spritam may be used for the treatment of partial onset seizures in patients aged 4 years and older, myoclonic seizures in myoclonic epilepsy patients aged 12 years and older, and primary generalized tonic-clonic seizures and other generalized epilepsy patients aged 6 years and older.

Common adverse events of Spritam included sleepiness, weakness, dizziness and infection. Children taking Spritam may also experience tiredness, aggressive behaviors, nasal congestion, decreased appetite and irritability.

While Spritam is the first 3D printed medication approved by the FDA, 3D printing has been previously used to produce medical devices.

“In my experience, patients and caregivers often have difficulty following a treatment regimen. Whether they are dealing with a swallowing disorder or the daily struggle of getting a child to take his or her medication, adherence can be a challenge. Especially for children and seniors, having an option for patients to take their medication as prescribed is important to managing this disease,” Marvin H. Rorick III, MD, neurologist at Riverhills Neuroscience in Cincinnati, said in the release.