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news.Aprecia Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Spritam levetiracetam for oral use as a prescription adjunctive therapy to treat partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.
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Spritam uses the company’s ZipDose Technology platform which in turn uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid.
Earlier, 3DP has been used to manufacture medical devices, and this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.
Aprecia chief executive officer Don Wetherhold said: "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.
"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."
The ZipDose technology allows the delivery of a high drug load, up to 1,000mg in a single dose.
The company noted that there is no measuring required for Spritam as its each dose is individually packaged.
According to the company, Spritam is expected to be available in the first quarter of next year.
The company developed ZipDose Technology platform using the 3DP technology that originated at Massachusetts Institute of Technology (MIT).