The first 3-D printed drug designed for people with epilepsy, who typically have a hard time swallowing pills, got a green light from the U.S. Food & Drug Administration this week.
Manufacturer Aprecia Pharmaceuticals says it hopes to have Spritam, its printed version of levetiracetam, a widely prescribed drug for the treatment of seizures, on the market by early 2016.
Aprecia describes Spritam as “a porous formulation that rapidly disintegrates.” The company’s manufacturing process arranges up to 1,000 mg of levetiracetam in a single dose.
Patients can take a tablet with a sip of liquid, making the pill easier to ingest, the company says. This is important for children, the elderly, and others who may have a hard time swallowing pills, the company says.
“Spritam is designed to fill a need for patients who struggle with their current medication experience,” said Don Wetherhold, chief executive officer of Aprecia.
Spritam is the first 3-D printed drug that has gained FDA approval, an agency spokeswoman says.
The printing technique that Aprecia used to create Spritam originated at the Massachusetts Institute of Technology. There is growing interest in printing biological specimens, and 3-D printing is used to manufacture some medical devices.