The US Food and Drug Administration (FDA) has approved 3D printed epilepsy medicine, called SPRITAM, for oral use, demonstrating once again the potential 3D printing has in healthcare and prescription medicines.
While 3D printing has been used previously to manufacture medical devices and even medicine in the UK, this approval marks the first time a drug product manufactured with 3D printing technology has been approved by the FDA.
The medicine, which is expected to be available in the first quarter of 2016, has been developed by US-based Aprecia Pharmaceuticals using “ZipDose” technology, a delivery system that creates premeasured doses which disintegrate in the mouth with a sip of liquid.
“By combining 3D printing technology with a highly-prescribed epilepsy treatment, SPRITAM is designed to fill a need for patients who struggle with their current medication experience,” said CEO of Aprecia, Don Wetherhold. “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.”
ZipDose Technology enables the delivery of a high drug load, up to 1,000 mg in a single dose. In addition, with SPRITAM there is no measuring required as each dose is individually packaged, making it easy to carry the treatment on the go.
“In my experience, patients and caregivers often have difficulty following a treatment regimen. 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,” said neurologist at Riverhills Neuroscience in Ohio, Marvin H. Rorick III, M.D. “Especially for children and seniors, having an option for patients to take their medication as prescribed is important to managing this disease.”
Missed doses of medication can undermine treatment outcomes for conditions like epilepsy. Patients with poor adherence to epilepsy drugs are more likely to have a breakthrough seizure. In one survey completed by patients, 71% acknowledged having forgotten, missed or skipped a dose of seizure medication at some time, and almost half reported having had a seizure after a missed dose at some time during treatment.