The U.S. Food and Drug Administration has given its approval for the first prescription medication manufactured by 3D printing, a dissolvable tablet for certain types of epileptic seizures.
Spritam from Aprecia Pharmaceuticals, intended for both children and adults, is made using 3D printing to create a layered pill that will quickly dissolve when taken with just a small amount of water or other liquid.
Aprecia says the medication uses the company's "ZipDose" technology to produce a porous pill that disintegrates rapidly with a small sip of liquid, even high doses of up to 1,000 milligrams.
"By combining [three-dimensional 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 Chief Executive Officer Don Wetherhold said in a release.
Spritam (levetiracetam) has received FDA approval as a prescription treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in children and adults with epilepsy, the company says.
While the FDA has previously approved medical devices such as prosthetics made using 3D printing, Aprecia's drug is the first 3D prescription tablet to receive approval, an agency spokeswoman confirmed.
3D printing is already being used in the dental field to create replicas of teeth and jaws and produce dental implants, while orthopedic surgeons have turned to the technology to make hip replacements.
Patients with epilepsy would benefit from the easily dissolvable character of Spritam, courtesy of its 3D creation, Marvin H. Rorick III, a neurologist at Riverhills Neuroscience in Cincinnati, Ohio, explained in the Aprecia release.
"In my experience, patients and caregivers often have difficulty following a treatment regimen," he says. "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."
A medication that is easy to take is important in managing epilepsy, he says.
Aprecia says it expects to have the 3D-printed Spritam on the market during the first quarter of 2016.
It also says it is using its proprietary 3D printing process to develop formulations of other drugs that will also dissolve rapidly and easily with a single sip of liquid.
"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," Wetherhold says.
