FDA Approves Aprecia’s Drug Using 3D Printing Technology

The US Food and Drug Administration has approved a drug made using three-dimensional printing technology, Aprecia Pharmaceuticals’ Spritam (levetiracetam), an oral drug for treating seizures caused by epilepsy. The drug was made using Aprecia’s proprietary ZipDose technology platform, which uses 3-D 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 FDA, according to Aprecia.

The drug was approved for oral use 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.

ZipDose enables the delivery of a high drug load, up to 1,000 mg in a single dose. As a result, Spritam allows the administration of the largest strengths of levetiracetam with a sip of liquid. In addition, with Spritam there is no measuring required as each dose is individually packaged. It s expected to be available in the first quarter of 2016.

Aprecia developed its ZipDose Technology platform using the 3D printing technology that originated at the Massachusetts Institute of Technology. The company is developing other high-dose formulations using this technology and intends to manufacture the product using is proprietary equipment. The company holds an exclusive, global license for pharmaceutical applications of this 3D printing technology.

Source: Aprecia Pharmaceuticals

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