FDA approves first 3D printed drug product
The FDA has approved Aprecia Pharmaceuticals’ SPRITAM levetiracetam 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. 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.
“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, chief executive officer 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.”
ZipDose Technology enables the delivery of a high drug load, up to 1,000mg in a single dose. As a result, SPRITAM enhances the patient experience—administration of even the largest strengths of levetiracetam with just a sip of liquid. 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. SPRITAM is expected to be available in the first quarter of 2016.
Nearly 3 million people in the U.S. have been diagnosed with active epilepsy, with an estimated 460,000 of those cases occurring in children. Additionally, in a recent survey of people age 65 and older living in an independent living facility, 15% reported difficulty swallowing. Other chronic conditions can impair the ability to swallow, further exacerbating the problem.