UPDATE 1-Valeant says epilepsy drug positive in late-stage trial
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May 13 (Reuters) - Valeant Pharmaceuticals International (VRX.N) said a late-stage pivotal study of its experimental epilepsy drug, retigabine, showed statistical significance in reducing seizures as compared to a dummy drug. The study, named RESTORE (Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy) 2, evaluated the 600 mg and 900 mg daily doses of retigabine in patients taking stable doses of one to three additional anti-epileptic drugs (AEDs).
Epilepsy is a common, chronic neurological disorder, marked by seizures stemming from abnormal electrical activity in the brain.
The most common side effects of retigabine in RESTORE 2 included dizziness, somnolence and fatigue, but were seen at lower levels than at a 1200 mg dose in the RESTORE 1 trial, the company said in a statement.
The company reported the RESTORE 1 data in February.
The drugmaker, which markets treatments for skin diseases, infectious diseases and neurological conditions, said it plans to submit applications for the approval of retigabine with the U.S. Food and Drug Administration and the European Medicines Evaluation Agency before the end of this year.
Shares of the company closed at $14.62 Monday on the New York Stock Exchange. (Reporting by Esha Dey in Bangalore; Editing by Jarshad Kakkrakandy)
