NDAORALCAPSULE, EXTENDED RELEASE
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
MOTPOLY XR (lacosamide) by Bayer is elucidated. First approved in 2023.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOTPOLY XR is an extended-release oral capsule formulation of lacosamide, a selective sodium channel modulator approved by FDA in May 2023. It works by enhancing slow inactivation of voltage-gated sodium channels to stabilize hyperexcitable neuronal membranes and inhibit repetitive neuronal firing. The product is indicated for epilepsy management in patients requiring convenient once-daily dosing.
Peak14.0 years to LOE
Early-stage peak-phase product with zero reported competitive pressure indicates potential for significant commercial expansion and robust team growth.
Mechanism of Action
elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Started Mar 2021
29 enrolled
Electroencephalographic Neonatal SeizuresEpilepsy
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
Started Dec 2020
48 enrolled
Epilepsy
Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy
Started Nov 2019
300 enrolled
Epilepsy
A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects
Started Jun 2017
30 enrolled
Healthy Male Chinese Volunteers
Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
Started May 2017
103 enrolled
Epilepsy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.