The United States Food and Drug Administration (FDA) has approved its first 3D-printed drug, the epilepsy-fighting Spritam by Aprecia. By turning to 3D printing, drugmakers were able to solve the problem of how to get a mega dose of medication – up to 1,000 mg – into an easy-to-swallow tablet. The solution, it turns out, is a porous formula that rapidly disintegrates with a single sip of liquid. Although the FDA has previously approved the use of various 3D-printed medical devices, this news marks the first consumable drug the agency supports.
Spritam is a prescription-only medication, and it won’t be available until sometime in early 2016, according to Aprecia. The drug will be administered to adults and children who suffer from a variety of seizure disorders related to epilepsy. Aprecia is calling the 3D-printed packaging “ZipDose Technology,” which is based on capabilities originally developed at the Massachusetts Institute of Technology. The quick-dissolving properties were developed specifically in response to epilepsy patients with trouble swallowing and for pediatric patients, who are often difficult to medicate.
Marvin H. Rorick III, M.D., neurologist at Riverhills Neuroscience in Cincinnati, Ohio, believes this type of drug-delivery system is a benefit because it will enable patients to stay on course with their medicine schedule, and avoid missed doses, which can be dangerous. “Especially for children and seniors, having an option for patients to take their medication as prescribed is important to managing this disease,” Rorick said in a statement.
In one patient survey, 71 percent said they forgot, missed or skipped a dose of seizure medication at some point, and almost half of those people reported having had a seizure after a missed dose at some time during treatment. A “breakthrough seizure” like that can happen after just one missed dose, so this new technology could wind up helping a lot of patients stay on track with their medication and steer clear of seizures.
Lead image via Shutterstock, image via Aprecia Pharmaceuticals