FDA approves first 3D-printed drug

WASHINGTON: In a world first, the US has approved a 3D-printed drug to treat certain types of seizures in epilepsy patients.

The drug, Spritam levetiracetam, is an oral prescription for treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy.

Aprecia Pharmaceuticals, the manufacturer of the drug, said it uses three-dimensional printing to produce a porous formulation that rapidly disintegrates with a sip of liquid.

While 3D printing has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the US Food and Drug Administration ( FDA), the company said.

"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, Chief Executive Officer of Aprecia.

A technology developed by Aprecia, known as ZipDose, enables the delivery of a high drug load, up to 1,000 mg per dose.

"As a result, Spritam enhances the patient experience - administration of even the largest strengths of levetiracetam with just a sip of liquid," Aprecia said in a statement.

"In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go," it said.

The drug is the first in a line of central nervous system products Aprecia plans to introduce as part of its plan to change how patients take prescribed medication.

Spritam is expected to be available in 2016.

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