FDA approves Aprecia’s 3D-printed anti-epileptic Spritam
BLUE ASH, Ohio — The Food and Drug Administration has approved Aprecia Pharmaceuticals’ Spritam (levetiracetam), an epilepsy treatment that is the first FDA-approved drug that uses 3D printing technology.
Aprecia’s ZipDose technology uses the layering process of 3D printing to stack porous layers of powdered medicine that are bound together. As a result, the drug will disintegrate with a sip of liquid — even doses as high as 1,000 mg.
“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,” Aprecia CEO Don Wetherhold, Chief Executive Officer said.
The technology has the potential to make taking anti-epilepsy medication easier for the almost 3 million people who have epilepsy, particular the 460,000 children who are diagnosed with epilepsy. In addition to working for older juveniles and adults, it is also indicated for use among patients as young as 4 years of age with partial onset seizures and patients with generalized tonic-clonic seizures for patients as young as 6 years of age. Patients with difficulty swallowing might also be able to benefit from Spritam.
“Whether they are dealing with a swallowing disorder or the daily struggle of getting a child to take his or her medication, adherence can be a challenge,” said Marvin H. Rorick III, M.D., neurologist at Riverhills Neuroscience in Cincinnati, Ohio. “Especially for children and seniors, having an option for patients to take their medication as prescribed is important to managing this disease.”
Spritam is expected to be available in the first quarter of 2016.