FDA approves first 3D-printed drug
The Food and Drug Administration has approved the first prescription drug made through 3D printing: a dissolvable tablet that treats seizures.
Aprecia Pharmaceuticals said Monday the FDA approved its drug Spritam for adults and children who suffer from certain types of seizures caused by epilepsy. The tablet is manufactured using what the company calls ZipDose technology, in which layers of medication are built up via 3D printing, allowing them to dissolve rapidly when taken with liquid.
The Ohio-based company says its printing system can package potent drug doses of up to 1,000 milligrams into individual tablets. It expects to launch Spritam in the first quarter of 2016.
The FDA has previously approved medical devices - including prosthetics - made with 3D printing. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process.
"By combining 3DP [printing] technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience," Aprecia CEO Don Wetherhold said in a statement.
He said the company, which is privately owned, plans to develop other medications using its 3D printing technique in coming years, and hopes "to transform the way patients experience taking medication."
Other uses of 3D printing in the medical field are becoming more widespread. Researchers are working to develop 3D-printed skin grafts to treat burn patients. Doctors are also increasingly turning to 3D printing to create customized implants for patients with rare conditions and injuries, including children who cannot be treated with adult-size devices. The FDA held a workshop last year for medical manufacturers interested in the technology.