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FDA Approves New Indication for Motpoly XR

New Indication for Motpoly XR (Lacosamide Extended-Release) Capsules for Primary Generalized Tonic-Clonic Seizures (Adjunctive Treatment)

SILVER SPRING, MD. June 7, 2024/FDA Approvals/ -- Today, the U.S. Food and Drug Administration (FDA) approved Aucta Pharmaceuticals Motpoly XR (lacosamide) capsules (100 mg, 150 mg, and 200 mg) for the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50kg. For this indication, Motpoly XR is to be used in addition to other seizure treatments.

Primary generalized tonic-clonic seizures are seizures that begin on both sides of the brain, causing a progression from stiffening (tonic) to jerking movements (clonic) with loss of consciousness.

About Motpoly XR

Motpoly XR™ (lacosamide) extended-release capsules C-V, are the first, and only once-daily formulation of lacosamide. Motpoly XR is bioequivalent to Vimpat® (lacosamide) film-coated tablets, C-V and provides a new once-daily option at equivalent doses. It will be available through retail pharmacies.

About Aucta Pharmaceuticals, Inc.

Aucta Pharmaceuticals, Inc. is a research and technology-based pharmaceutical company focusing on the development and commercialization of niche generic and branded specialty products. The company's corporate strategy is to focus on proven molecules, and, through innovation, create new therapeutics with lower scientific risk that fulfill unmet medical needs. Its specialty division has a therapeutic focus in CNS, Inhalation, Ophthalmics, and Other Specialty fields. For more information, visit www.auctapharma.com.

Source: Aucta Pharmaceuticals, Inc.; Drugs@FDA, Motpoly XR FDA Product Information.

Posted: June 2024

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