BLUE ASH, Ohio — Aprecia Pharmaceuticals Co. has received Food and Drug Administration approval for Spritam levetiracetam for oral use, an epilepsy treatment made using three-dimensional printing (3DP) technology.
The company said Monday that the medication is the first drug product manufactured with 3DP technology that has been approved by the FDA.
Spritam uses Aprecia’s proprietary ZipDose Technology platform, which employs 3DP to produce a porous formulation that rapidly disintegrates with a sip of liquid.
ZipDose Technology enables the delivery of a high drug load, up to 1,000 mg in a single dose, according to Aprecia. Consequently, Spritam provides an enhanced patient experience by allowing the administration of even the largest strengths of levetiracetam with just a sip of liquid. No measuring is needed since each dose is individually packaged, making it easy to carry the medication on the go.
SPRITAM is slated to be released in the first quarter of 2016. Aprecia said it developed ZipDose using the 3DP technology that originated at Massachusetts Institute of Technology. The company added that it holds an exclusive global license for pharmaceutical applications of this 3DP technology.
“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,” stated Don Wetherhold, chief executive officer 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.”
About 3 million people in the United States have been diagnosed with active epilepsy, and an estimated 460,000 of those cases are children. In a recent survey of people age 65 and older living in an independent living facility, 15% reported difficulty swallowing, Aprecia reported. Other chronic conditions can impair the ability to swallow, further exacerbating the problem.
Swallowing difficulties are one reason why some patients don’t take their medication as prescribed, and missed doses of medication can impact treatment outcomes for conditions like epilepsy, according to Aprecia. 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.
“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,” commented Marvin Rorick, M.D., neurologist at Riverhills Neuroscience in Cincinnati. “Especially for children and seniors, having an option for patients to take their medication as prescribed is important to managing this disease.”