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Valeant Pharmaceuticals Announces Preliminary Results From Its Phase IIa Retigabine Study For The Treatment Of Postherpetic Neuralgia (PHN)

August 26, 2009

Valeant Pharmaceuticals International (NYSE: VRX) announced prefatory results from its Phase IIa proof-of-concept clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia (PHN), a painful and common complication of shingles. While retigabine was in most cases well tolerated, the study did not meet its pre-specified primary efficacy endpoint. Further detailed analyses are warranted and are ongoing.

“As is typical in many proof-of-concept studies, these results are inconclusive at this life with regard to the potential utility of retigabine in PHN patients,” stated J. Michael Pearson, presiding officer and chief executive officer. “The treatment duration was relatively short and with limited statistical powering for the meditate overall. There are great number supplemental analyses that be the subject of over and above to be undertaken and these will be performed over the next separate months. Moreover, given that the temporary results from this study will not impact the submission of our New Drug Application as antidote to retigabine in falling sickness, we rest focused on the submission as our number one antecedence.”

The study was a randomized, double-blind, placebo-controlled Phase IIa proof-of-concept study with 187 patients randomized 2:1 of retigabine against placebo for a management period of up to 10 weeks. The study was conducted in approximately 50 trial locations. Study patients were titrated to their individually determined greatest tolerated dose not beyond the amplitude of 300 mg to 900 mg per day. The primary outcome tax was the comparison of the average pain intensity over the last seven days of maintenance therapy through retigabine versus placebo. Pain intensity was measured on a standard 0 - 10 numerical rating scale.

About PHN

PHN is a painful complexity of Herpes Zoster, a condition commonly known as “shingles.” Shingles results from a reactivation of the Varicella Zoster venom, the like agent that causes chicken pox. Patients with shingles typically have a painful blistering hot-brained that lasts for several weeks. PHN occurs when brace fibers are damaged during an outbreak of shingles, causing chronic and often excruciating pain that may extend in opposition to months or years. Currently available treatments for PHN include topical medications, over-the-counter analgesics, tricyclic antidepressants and antiepileptics.

About Retigabine

Retigabine, a first-in-class neuronal potassium channel opener, is currently in late-stage development in the same proportion that an adjunctive treatment for patients by partial-onset seizures. In Phase III falling sickness trials, retigabine was shown to exist efficacious with a demonstrated depression in monthly seizure rates.

Retigabine Important Note

Retigabine has not been found by means of the Food and Drug Administration (FDA) or any other regulatory agency to be secure or effective in the diagnosis, mitigation, treatment or restorative of any disease or indisposition. It may not have existence 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 judgment, abnormal gait, paresthesia, diplopia, incoordination, forcibleness, aberrant vision, asthenia, headache, strong dislike and diarrhea.

About Valeant

Valeant Pharmaceuticals International (NYSE: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology.

FORWARD-LOOKING STATEMENTS

This press deliverance may comprise forward-looking statements, including, but not limited to, statements regarding retigabine’s possible in the treatment of postherpetic neuralgia and the impact of this clinical study on the filing of the New Drug Application. Forward-looking statements may have existence identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “possible,” or “continue” and variations or similar expressions. These statements are based upon the present expectations and beliefs of management and are subject to certain risks and uncertainties that could originate certain 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 discussed in the gang’session greatest in number recent annual or quarterly report filed with the Securities and Exchange Commission, which factors are incorporated herein by concern. Readers are cautioned not to place undue reliance on any one of these forward-looking statements. Valeant undertakes in no degree obligation to update some of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect not merely imagined outcomes.

Source: Valeant Pharmaceuticals International

Written by Samanta · Filed Under Pharmacy Industry News