Skip to main content

FDA Approves Motpoly XR

FDA Approves Aucta Pharmaceuticals Motpoly XR (lacosamide) Capsules for Partial Onset Seizures

SILVER SPRING, MD. May 4, 2023/FDA Approvals/Aucta Pharmaceuticals -- Today, the U.S. Food and Drug Administration (FDA) approved the use of Motpoly XR (lacosamide) capsules (100 mg, 150 mg, and 200 mg) for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg in adults and pediatric patients weighing at least 50 kg.

About Motpoly XR

Motpoly XR™ (lacosamide) extended-release capsules are the first, and only once-daily formulation of lacosamide. Motpoly XR is approved for the treatment of partial-onset seizures in adults and pediatric patients weighing at least 50 kg.

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.

Warnings and Precautions

Antiepileptic drugs increase the risk of suicidal behavior and ideation. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors.

Motpoly XR may cause dizziness and ataxia in patients. Advise patients not to operate machinery or motor vehicles until they know how Motpoly XR affects them.

Obtain an ECG before beginning Motpoly XR, and after titration to steady-state maintenance dose in patients with underlying proarrhythmic conditions or those on concomitant medications that affect cardiac conduction. Closely monitor these patients.

Motpoly XR may cause syncope in patients.

Gradually withdraw Motpoly XR to minimize the potential of increased seizure frequency.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/multi-organ hypersensitivity has been reported and can be life-threatening or fatal. If signs or symptoms are present, immediately evaluate the patient. Discontinue Motpoly XR if there is no alternative etiology.

The most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence.

Pregnancy: Based on animal data, Motpoly may cause fetal harm.

Drug interactions: Consider dose reduction in patients with renal or hepatic impairment taking strong inhibitors of CYP3A4 and CYP2C9.

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

Posted: May 2023

Related articles

Motpoly XR (lacosamide) FDA Approval History

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.