MOTPOLY XR

Growth

lacosamide

NDAORALCAPSULE, EXTENDED RELEASE
Approved
May 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20

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.

Clinical Trials (5)

NCT04519645Phase 2Terminated

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
NCT04627285Phase 3Completed

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
NCT03204474Phase 1Completed

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
NCT02710890Phase 2/3Completed

Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.

Started May 2017
103 enrolled
Epilepsy
NCT03086382Phase 1Completed

A Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects

Started Feb 2017
24 enrolled
Healthy Male Volunteers

Loss of Exclusivity

LOE Date
Jun 5, 2040
173 months away
Patent Expiry
Jun 5, 2040

Patent Records (3)

Patent #ExpiryTypeUse Code
11337943
Jun 5, 2040
Product
U-3954
11883374
Jun 5, 2040
Product
U-3660
12042474
Jun 5, 2040
Product
U-3660