US approves drug manufactured with 3D printer

By Barry Eitel

SAN FRANCISCO

The Food and Drug Administration (FDA) on Monday approved an oral use drug that utilizes three-dimensional printing technology – a groundbreaking move that could change the future of medicine.

Aprecia Pharmaceuticals is behind the drug, Spritam, that received the clear from the FDA. Used to treat seizures related to epilepsy, Spritam uses a 3D printer to create a specific oral dose of the medication for a patient. The printer creates a porous formation that quickly dissolves when in contact with liquid.

Aprecia calls the technology “ZipDose” and believes it could significantly improve how patients take medication.

“By combining 3DP technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience,” Aprecia chief executive Don Wetherhold said in a statement. “This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.”

Companies have used 3D printers to build medical devices – surgeons have used the technology to create hip replacements custom-sized for specific patients, for example. But Spritam is the first drug to use it that has gained the FDA’s blessing.

Almost 3 million Americans have been diagnosed with epilepsy, according to Aprecia, including 460,000 children.

More than 70 percent of epilepsy patients say they have forgotten or skipped taking a dose of medication – action that can undermine treatment and lead to damaging seizures.

By using 3D printers to create custom, easily swallowed doses that require no measuring by the patient, Aprecia believes it can take much of the difficulty out of epilepsy treatment, especially for children suffering from the condition.

The company claims Spritam will be available by the first quarter of 2016, and that it is hard at work on other medical uses for 3D printers.