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Valeant Pharmaceuticals Announces Publication of Retigabine Phase 2,Study Data in Neurology

line). Additionally, the percent of "responders" - those who had a 50 percent or greater reduction in seizure frequency - was significantly greater for the 900 and 1,200 mg groups than placebo (32 and 33 percent vs. 16 percent, respectively).

The double-blind study involved 73 centers in 19 countries (Europe, Australia and the United States), and included 396 patients who were 16 to 70 years of age with partial-onset seizures refractory to current treatment. After an initial 8-week baseline period, patients were randomly assigned to receive retigabine (600, 900 or 1,200 mg/day) or placebo, while maintaining their current therapies. Dosing of retigabine was increased gradually over a period of 8 weeks and then maintained for an additional 8 weeks.

It is currently estimated that 30 percent of those affected by epilepsy are not adequately controlled by existing medications. Retigabine is believed to act primarily by opening neuronal potassium-channels resulting in a hyperpolarizing shift that modulates the excitability of the neuronal cells. This mechanism of action (MOA) is different than other antiepileptic drugs.

Retigabine is an investigational compound that has not been found by the Food and Drug Administration (FDA) or any other regulatory agency to be safe or effective in the diagnosis, mitigation, treatment or cure of any disease or illness. It may not be sold or promoted in the United States unless and until the FDA has approved a New Drug Application. Similar restrictions apply in other countries.

About RESTORE

Retigabine is currently being investigated in the Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy (RESTORE), two large, pivotal Phase 3 trials that will evaluate the safety and efficacy of retigabine in refractory epilepsy patients who are receiving one, two or three antiepileptic drugs (AEDs).

At the completion of these trials, retigabine will have been studied in more than 1,300 patients, mor
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