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First Proof-of-Concept Study of Potassium Channel Opener as a Potentially Novel Treatment for Pain Associated with Postherpetic Neuralgia
ALISO VIEJO, CA, USA | November 28, 2007 | Valeant Pharmaceuticals International (NYSE:VRX) today announced that it has enrolled the first patient in its Phase 2 clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia (PHN), a painful and common complication of shingles.
“We are eager to investigate whether retigabine, our new novel potassium channel opener, will be effective in treating neuropathic pain,” said Timothy C. Tyson, president and chief executive officer. “Retigabine shows promise as an effective analgesic in animal pain models. We are optimistic that retigabine might offer a much-needed, new option for physicians treating patients with debilitating and painful conditions such as PHN.”
The randomized, double-blind, placebo-controlled Phase 2a proof-of-concept study is designed to enroll a total of 180 patients with 120 patients randomized to treatment with retigabine and 60 randomized to placebo treatment for a treatment period of up to 10 weeks. The study will be conducted in up to 40 trial locations. Study patients will be titrated to their individually determined maximum tolerated dose within the range of 300 mg to 900 mg per day. The primary outcome assessment will be the comparison of the average pain intensity over the last seven days of maintenance therapy with retigabine versus placebo. Pain intensity will be measured on a standard 0 – 10 numerical rating scale.
According to IMS MIDAS, the global market for antiepileptic drugs is $13.6 billion on a moving annual total (MAT) basis. The market is defined by a multitude of indications ranging from epilepsy to pain, migraine and mood disorders.
About PHN
PHN is a painful complication of Herpes Zoster, a condition commonly known as “shingles.” Shingles results from a reactivation of the Varicella Zoster virus, the same agent that causes chicken pox. Patients with shingles typically have a painful blistering rash that lasts for several weeks. PHN occurs when nerve fibers are damaged during an outbreak of shingles, causing chronic and often excruciating pain that may continue for months or years. Currently available treatments for PHN include topical medications, over-the-counter analgesics, tricyclic antidepressants and antiepileptics.
To learn more about the clinical trial locations evaluating retigabine for the treatment of pain associated with PHN, visit www.clinicaltrials.gov.
About Retigabine
Retigabine, a first-in-class neuronal potassium channel opener, is also currently in late-stage Phase 3 development as an adjunctive treatment for patients with partial-onset seizures. In Phase 2 epilepsy trials, retigabine was shown to be efficacious with a demonstrated reduction in monthly seizure rates.
Retigabine Important Note
Retigabine 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 NDA. Similar restrictions apply in other countries.
The most common side effects associated with retigabine to date include somnolence, dizziness, confusion, speech disorder, vertigo, tremor, amnesia, abnormal thinking, abnormal gait, paresthesia, diplopia, incoordination, nervousness, abnormal vision, asthenia, headache, nausea and diarrhea.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including, but not limited to, statements regarding enrollment in and completion of the company’s Phase 2a program for retigabine. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties related to the clinical development of new products, regulatory approval processes, and other risks and uncertainties discussed in the company’s filings with the SEC. Valeant wishes to caution the reader that these factors are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. Valeant also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this release. The company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes.
SOURCE: Valeant Pharmaceuticals International |
