Healthcare Industry News: Neuropathic Pain
News Release - November 27, 2007
Valeant Pharmaceuticals Completes Enrollment of Second Pivotal Phase 3 Trial for Epilepsy Drug RetigabineRESTORE2 Trial Enrolls 539 Patients Across 69 Investigational Sites; NDA Filing on Track for Mid-2008
ALISO VIEJO, Calif.--(HSMN NewsFeed)--Valeant Pharmaceuticals International (NYSE:VRX ) today announced that it has achieved full enrollment in RESTORE2, its second pivotal Phase 3 study of retigabine in the treatment of epilepsy. Retigabine is a first-in-class neuronal potassium channel opener demonstrated to be effective in a recently published Phase 2b epilepsy study. The RESTORE1 and RESTORE2 trials (Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy) are designed to evaluate the efficacy and safety of retigabine as an adjunctive therapy in patients with refractory partial-onset seizures who are receiving one, two or three concomitant antiepileptic drugs (AEDs). RESTORE2 is investigating retigabine at 600 and 900 milligrams per day whereas RESTORE1 is investigating retigabine at 1,200 milligrams per day.
“More than 50 million people worldwide have epilepsy and the global market for AEDs is more than $13 billion and growing,” said Timothy C. Tyson, Valeant’s president and chief executive officer. “The development of retigabine, which will be the first and only potassium channel opener for the treatment of refractory epilepsy, is our highest R&D priority at Valeant. We are pleased to be leading the way in the research and development of potassium channel openers for the treatment of important neurological disorders such as epilepsy and Neuropathic Pain.”
Five hundred and thirty-nine patients have enrolled in RESTORE2, which is being conducted in 69 sites across Europe, Israel, Australia, South Africa and the United States. The RESTORE1 trial is being conducted in 49 sites across the United States, Argentina, Mexico, Brazil and Canada. To date, more than 85 percent of eligible patients involved in RESTORE trials have chosen to enter into ongoing open-label extension studies.
“Despite the availability of many new antiepileptic drugs during the last decade, more than 30 percent of people with epilepsy still suffer regular seizures,” said RESTORE2 principal investigator Martin Brodie, M.D., University of Glasgow, Scotland. “With the European retigabine adjunctive trial program completely enrolled, the day is nearer when this exciting new medicine with its wholly novel mechanism of action may reach the marketplace.”
Currently, there are no AEDs on the market which function by opening the neuronal potassium channel. Adding to Valeant’s growing expertise with this novel therapeutic class of AEDs, the company recently announced the selection of several pre-Investigational New Drug (IND) candidates for its next-generation potassium channel opener program. Valeant expects to file an Investigational New Drug for the lead candidate, VRX698, in mid-2008.
Following the anticipated completion of the RESTORE trials in the second quarter 2008, Valeant plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application in Europe for retigabine with an anticipated launch in 2009.
RESTORE1 and RESTORE2 are both randomized, double-blind, placebo-controlled, multi-center, parallel group studies. The primary endpoint of RESTORE2 is a change in total partial seizure frequency per four weeks from baseline to the double-blind period (titration phase and maintenance phase). For European Medicines Agency (EMEA) review, the primary endpoint is the proportion of responders, where a “responder” is defined as a patient experiencing a reduction of at least 50 percent in total partial seizure frequency per four weeks from baseline to the maintenance phase of the double-blind period. Retigabine will have been studied in more than 1,750 subjects, including more than 1,350 patients with epilepsy, at the completion of the RESTORE trials. More than 350 of these patients will have taken retigabine for 12 or more months, including a few who have taken retigabine for six or more years.
Data from the RESTORE1 trial is anticipated in the first quarter of 2008. The company also anticipates that it will have data from the RESTORE2 trial in the second quarter of 2008.
Epilepsy is one of the most common neurological diseases, affecting approximately 50 million people worldwide. It 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.
Approximately 30 percent of people with epilepsy experience seizures that are not adequately controlled with currently prescribed AEDs. Individuals with epilepsy who do not achieve remission with AEDs are often severely disabled by their condition, have an unsatisfactory quality of life and are at increased risk of sudden unexpected death. Refractory epilepsy is associated with memory loss, lower levels of school performance, depression and impaired psychosocial skills.
About Potassium Channel Openers
Potassium channels are one of the voltage-gated ion channels found in neuronal cells and are important determinants of neuronal activity. Numerous ion-channel mutations have been linked to epilepsy, and many antiepileptic medications modulate sodium or calcium channels. Potassium channels have been demonstrated in animal models to be critical in regulating membrane potential, yet little has been done to develop therapeutic modulators prior to retigabine. It is believed that by facilitating the opening of specific neuronal potassium channels, retigabine causes a hyperpolarizing shift in the potassium current and thereby reduces the excitability of neuronal cells. Dampening of neuronal excitability is important mechanism for reducing the potential for seizures as well as for the treatment of Neuropathic Pain.
Retigabine Important Note
Retigabine has not been found by the 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.
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.
This press release contains forward-looking statements, including, but not limited to, statements regarding enrollment in and completion of the company’s Phase 3 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
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