Compliance Management / Small Molecule

First 3D-Printed Tablet Approved by FDA

Aug 04, 2015

Aprecia Pharmaceuticals Co. announced that the FDA has approved Spritam levetiracetam as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.

Spritam utilizes Aprecia’s proprietary ZipDose Technology platform, which uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid.

While 3DP 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 FDA, according to a press release.

“By combining 3DP 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.”

Spritam is expected to be available in the first quarter of 2016.

Read the full release