The U.S. Food and Drug Administration has given its first approval to a drug manufactured with 3-D printers.
The drug, called Spritam, was approved as an oral drug to be used for adults and children with epilepsy. The 3-D printing technique creates a porous pill that dissolves with water, so patients do not have to swallow it. That function is important for epilepsy patients, who can have trouble swallowing medication, and for caretakers who may have trouble getting children to take medication.
To create the drug, Aprecia Pharmaceuticals Co. developed ZipDose Technology, which uses 3-D printing technology licensed from the Massachusetts Institute of Technology.
Beyond this epilepsy pill, the company plans to produce a line of drugs designed to treat other central nervous system diseases, which could include depression, schizophrenia or Parkinson’s disease.
The 3-D printing process makes the drugs layer-by-layer, a very precise way of manufacturing the pills. Wetherhold said this could lead to future uses of the technology, including extended release pills.
The company has completed validation batches of Spritam and expects to launch the drug in the first quarter of 2016. Aprecia expects the drug to be priced similarly to other branded epilepsy drugs.