FDA Approves First 3D Printed Drug Product

Aprecia Pharmaceuticals Company has announced that the FDA has approved Spritam levetiracetam for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. Spritam utilizes Aprecia’s proprietary ZipDose Technology platform, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.

“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,” said Don Wetherhold, CEO of Aprecia. “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 1000 mg in a single dose. As a result, Spritam enhances the patient experience — administration of even the largest strengths of levetiracetam with just a sip of liquid. In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go. Spritam is expected to be available in the first quarter of 2016.

“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 Marvin H. Rorick III, neurologist at Riverhills Neuroscience in Cincinnati, Ohio. “Especially for children and seniors, having an option for patients to take their medication as
prescribed is important to managing this disease.”

Nearly three million people in the US have been diagnosed with active epilepsy, with an estimated 460,000 of those cases occurring in children. In addition, in a recent survey of people age 65 and older living in an independent living facility, 15% reported difficulty swallowing. Other chronic conditions can impair the ability to swallow, further exacerbating the problem. 

While there are many reasons, including swallowing difficulties, for which patients may not take their medication as prescribed, 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.