> Publication of Phase 2 Study Data in Neurology

Retigabine (Epilepsy)
Valeant Pharmaceuticals announced the publication of Phase 2 data for retigabine, a first-in-class neuronal potassium channel opener, in Neurology, a leading independent, scientific journal (Read the press release). The authors concluded that retigabine was efficacious with a demonstrated reduction in monthly seizure rates in this study.

In addition, RESTORE (Retigabine Efficacy and Safety Trial for partial onset Epilepsy) trials are two Phase 3 trials (RESTORE1 & RESTORE2) designed to determine the efficacy and safety of retigabine used as adjunctive therapy in refractory epilepsy patients with partial-onset seizures.  These Phase 3 studies are a randomized, double-blind, placebo-controlled, multi-center, parallel-group studies to assess the efficacy and safety of retigabine.

Valeant Pharmaceuticals plans to submit the NDA/MAA for Retigabine IR (Epilepsy) in the middle of 2008.

Valeant is also in the process of evaluating retigabine as a sustained release formulation.

Retigabine IR (Pain)
Valeant Pharmaceuticals has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for retigabine in the treatment of pain associated with post-herpetic neuralgia.

Valeant posts protocol information for all ongoing Phase 2, 3, and 4 trials to the National Institutes of Health's (NIH) ClinicalTrials.gov website. To learn more about the clinical trials that are under way or to find out if a study is enrolling patients in your area, please visit www.clinicaltrials.gov.

Post-herpetic neuralgia
Post-herpetic neuralgia is a painful complication of herpes zoster. Post-herpetic neuralgia results when nerve fibers are damaged during an outbreak of herpes zoster, causing chronic and often excruciating pain that may continue for months or years. Currently available treatments for post-herpetic neuralgia include topical medications, over-the-counter analgesics, tricyclic antidepressants and anticonvulsants.

Epilepsy
Epilepsy is one of the most common neurological diseases, affecting over 50 million people worldwide, and 2.7 million Americans of all ages.  It is estimated that approximately 200,000 new cases of seizures and epilepsy occur each year in the U.S., with 10 percent of the American population experiencing a seizure in their lifetime.

Epilepsy is a brain disorder in which clusters of nerve cells, or neurons, in the brain sometimes signal abnormally.  In epilepsy, the normal pattern of neuronal activity becomes disturbed, causing a seizure. Seizures can cause changes in behavior and emotions, strange sensations and sometimes convulsions, muscle spasms, and loss of consciousness.

Epilepsy is a disorder with many possible causes.  Anything that disturbs the normal pattern of neuron activity – from illness to brain damage to abnormal brain development – can lead to seizures.  In 70 percent of new cases, no cause is apparent.

The global market for anticonvulsants is over 10 billion dollars.

The most common side effects associated with retigabine to date include somnolence, dizziness, abnormal vision, asthenia, headache, nausea and diarrhea.