The US Food and Drug Administration has approved Aprecia Pharmaceuticals Co’s epilepsy treatment Spritam, the world’s first 3D printed drug.
Spritam (levetiracetam) is made with Aprecia’s ZipDose technology which uses three-dimensional printing to produce a porous formulation that rapidly disintegrates with a sip of liquid. This system allows for higher dosage into a tablet – up to 1,000mg – and chief executive Don Wetherhold said Spritam is designed to fill a need for patients who struggle with their current medication experience.
He added that “this is the first in a line of central nervous system products Aprecia plans to introduce”. Although the FDA has previously approved 3D-printed medical devices, this is the first time a 3D-printed product has been given the green light.
Spritam is expected to be available in the first quarter of 2016.