Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide

PISCATAWAY, N.J., Feb. 26, 2024 /PRNewswire/ -- Aucta Pharmaceuticals, Inc., a private specialty pharmaceutical company focused on niche generic and branded specialty products, today announced the commercial launch of MOTPOLY XR (lacosamide) extended-release capsules C-V (100, 150 and 200 mg).  MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in 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.

"MOTPOLY XR marks a major milestone for Aucta as our 1^st branded pharmaceutical product to enter the US market. It will be supported by a full commercial infrastructure including field and inside sales, managed care and formulary access support, and a copay savings program," said Shoufeng Li, PhD., CEO of Aucta Pharmaceuticals.

IMPORTANT SAFETY INFORMATION

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 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.

MOST COMMON ADVERSE REACTIONS

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.

To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, please visit www.MotpolyXR.com and please see full Prescribing Information.

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.

Vimpat^® is a registered trademark used under license from Harris FRC corporation.

SOURCE Aucta Pharmaceuticals, Inc.