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FDA approves first 3D epilepsy drug
FDA approved epilepsy drug levetiracetam (Spritam), the first FDA-approved drug that utilizes three-dimensional printing (3DP).
FDA approved epilepsy drug levetiracetam (Spritam), the first FDA-approved drug that utilizes 3-dimensional printing (3DP).
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According to the drug’s manufacturer, Aprecia Pharmaceuticals, Spritam utilizes ZipDose Technology 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 manufactured with this technology has been approved by FDA, according to Aprecia.
Spritam, expected to be available in the first quarter of 2016, is an adjunct therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.
“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.”
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ZipDose Technology enables the delivery of a high drug load, up to 1,000 mg in a single dose. As a result, even the largest strengths of levetiracetam can be administered with just a sip of liquid. In addition, no measuring required as each dose is individually packaged, making it easy to carry this 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 Marvin H. Rorick III, MD, 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.”
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.
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