First 3-D printed prescription drug to be made in Blue Ash

WASHINGTON — The Food and Drug Administration has approved the first prescription drug made through 3-D 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 through a layered process via 3-D printing and dissolves when taken with liquid.

Spritam will initially go into production in early 2016 at Aprecia’s East Windsor, N.J., facility. Production will begin at its Blue Ash facility in mid-2016, Aprecia spokeswoman Jennifer Zieverink told The Enquirer.

Spritam is Aprecia’s first product. Aprecia has three other pharmaceuticals that all use the ZipDose 3D printing technology in development, she said.

Mason-based Prasco Laboratories and its parent company, Scion Companies, own the controlling interest in Aprecia, which was founded in 2003.

Spritam will be 3D-printed in batches of several tablets. A price for Spritam has not yet been determined, Zieverink said.

The 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 3-D printing. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process.

Aprecia said in a statement it plans to develop other medications using its 3-D platform in coming years, including more neurological drugs. The company is privately owned.

Doctors are increasingly turning to 3-D 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.