Motpoly XR FDA Approval History
Last updated by Carmen Pope, BPharm on June 13, 2024.
FDA Approved: Yes (First approved May 4, 2023)
Brand name: Motpoly XR
Generic name: lacosamide
Dosage form: extended-release capsule
Company: Aucta Pharmaceuticals, Inc.
Treatment for: Seizures
Motpoly XR is an extended-release capsule containing lacosamide, which may be used to treat adults and children weighing at least 110 pounds (50kg) with partial-onset seizures or primary generalized tonic-clonic seizures (adjunctive therapy).
- 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 is available through retail pharmacies.
- 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.
- The most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence.
Development timeline for Motpoly XR
Further information
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