FDA approves the first 3D printed drug product

Pharmaceutical & Medical Packaging News staff in Digital Printing on August 04, 2015

Aprecia Pharmaceuticals Company announced 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.

It is expected to be available in the first quarter of 2016. 

SPRITAM uses 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, Aprecia states 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," says Don Wetherhold, CEO of Aprecia, in a released statement. "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."

According to Aprecia, 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, Aprecia states that with SPRITAM there is no measuring required as each dose is individually packaged, making it easy to carry on the go.

"In my experience, patients and caregivers often have difficulty following a treatment regimen," says Marvin H. Rorick III, M.D., neurologist at Riverhills Neuroscience in Cincinnati, OH. “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. 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 United States have been diagnosed with active epilepsy, with an estimated 460,000 of those cases occurring in children, according to Aprecia. Additionally, in a recent survey of people age 65 and older living in an independent living facility, 15 percent 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, Aprecia notes that missed doses of medication can undermine treatment outcomes for conditions like epilepsy, such as an increased likelihood of a breakthrough seizure.

Aprecia developed its ZipDose Technology platform using the 3DP technology that originated at MIT. Using 3DP as a catalyst, Aprecia is developing formulations of medicines that rapidly disintegrate with a sip of liquid, even at high dose loads. The company intends to manufacture them on Aprecia's proprietary equipment. Aprecia holds a license for pharmaceutical applications of this 3DP technology.

For more company information, visit https://www.aprecia.com.

Click here for fact sheets and a video on SPRITAM. 

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