First 3D printed drug approved by FDA

The first 3D printed drug has been approved by the American Food and Drug Administration (FDA) for the treatment of epilepsy

Aprecia Pharmaceuticals’ Spritam levetiracetam is for oral use as a prescription adjunctive therapy for the treatment of seizures in adults and children with epilepsy.

Spritam uses Aprecia’s proprietary ZipDose Technology platform that uses 3D printing to produce a porous formulation that rapidly disintegrates with a sip of liquid.

Marvin Rorick, neurologist at Riverhills Neuroscience in Cincinnati, said: “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.”

ZipDose Technology enables the delivery for a drug load of up to 1,000 mg in a single dose and is expected to be available in the first quarter of 2016.

Don Wetherhold, chief executive officer of Aprecia, said: “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.”