The first FDA-approved 3D printing drug officially launched

Today, Aprecia Pharmaceuticals announced that it has been officially marketed by the US Food and Drug Administration (FDA)-approved SPRITAM (Lesilacetam) tablet, the first FDA-approved prescription drug product manufactured using 3D printing technology. . SPRITAM is indicated for the adjuvant treatment of localized epilepsy, myoclonic epilepsy and primary generalized tonic clonic seizures. Aprecia is the world's first and only company to develop and manufacture pharmaceutical products using 3D printing technology on a commercial scale. The pharmaceutical company also uses proprietary ZipDose technology to improve patient care.

The first FDA-approved 3D printing drug officially launched

As a chronic brain disease, epilepsy affects people from all over the world. In the event of a seizure, a temporary involuntary convulsion (ie, a partial seizure or a systemic episode) in a part of the body or the entire body, sometimes accompanied by loss of consciousness and incontinence. Today, in many countries, patients with this disease are still misunderstood and discriminated, seriously affecting the quality of life of patients and their families. About 50 million people worldwide suffer from epilepsy. It is estimated that 2.4 million people worldwide are diagnosed with epilepsy each year. In high-income countries, the average number of new cases per year for the general population is 30 to 50 per 100,000 people. In low- and middle-income countries, this number has doubled.

Although the development of modern medicine makes the treatment of epilepsy not expensive, its patients often have the challenge of swallowing difficulties when taking drugs. Two recent independent online surveys found that nearly half of healthy American adults surveyed had difficulty swallowing tablets and capsules, and 8% admitted that they did not take the required doses due to dysphagia. In addition, an independent survey conducted in patients with epilepsy found that failure to follow the doctor's advice proved to be a serious deterrent to the treatment: 45% of patients with epilepsy would have an episode even if they missed a dose.

Aprecia Pharmaceuticals' ZipDose technology effectively solves the problem of swallowing patients with epilepsy. ZipDose technology combines the unique manufacturing capabilities of pharmaceutical formula science with 3D printing. Drugs produced and developed using ZipDose technology dissolve rapidly in the mouth even at high doses, making it easy and convenient for patients to take their medications. The patient's non-compliance due to swallowing problems will be greatly reduced, and the therapeutic effect of epilepsy will be improved from another aspect.

Don Wetherhold, CEO of Aprecia, commented, “We have found some areas where drugs are not user-friendly in the process of exploring the use of 3D printing technology in the production of prescription drugs. SPRITAM is designed to revolutionize the use of epilepsy drugs, which allows patients to With more treatment options for caregivers, this is one of our range of products."

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