We recently profiled Aprecia Pharmaceuticals (Langhorne, PA), an innovative company that is using 3D printing to manufacture prescription drugs. In that article, Aprecia said that it expects FDA approval for the first pharmaceutical product using its ZipDose technology some time this year. Well, we didn't have to wait long: Aprecia announced yesterday that FDA has approved its 3D-printed drug for the treatment of epilepsy. This reportedly marks the first time that a pharmaceutical product manufactured using this technology has been approved by FDA.
Spritam levetiracetam for oral use is designed for patients who have difficulty following a treatment regimen, either because they have a swallowing disorder or, as in the case of children, because they are forgetful or reluctant to take their medication. ZipDose technology produces a porous formulation that instantly disintegrates with a sip of liquid. Moreover, the technique enables delivery of a high drug load—up to 1,000 mg in a single dose—and no measuring is required, as each dose is individually packaged for on-the-go use.
Nearly three million people in the United States have been diagnosed with active epilepsy, according to the Centers for Disease Control, and in one survey, 71% of patients said that they had forgotten, missed or skipped a dose of seizure medication at some time. Almost half reported having had a seizure after a missed dose at some time during treatment.
Spritam is expected to be available in the first quarter of 2016, according to Aprecia. The company has other drugs in development for central nervous system disorders that will use ZipDose technology to produce fast-melt medication.