Federal regulators approved the first 3D-printed drug, a groundbreaking decision that could change how drugs are made.
The Food and Drug Administration approved the anti-seizure drug Spritam on Monday, according to the drug’s manufacturer, Aprecia Pharmaceuticals.
Spritam is made through a 3D printing technique that produces a porous formulation that “rapidly disintegrates with a sip of liquid,” the company said.
The technique could be helpful for children and seniors who may have trouble taking traditional medication, said Dr. Marvin Rorick, a Cincinnati neurologist.
“In my experience, patients and caregivers often have difficulty following a treatment regimen,” he said. “Whether they are dealing with a swallowing disorder or the daily struggle of getting a child to take his or her medication, adherence can be a challenge.”
The FDA has previously approved medical devices created through the technology, but never a drug.
Aprecia holds a license for pharmaceutical applications with the 3D technique.
