Healthcare Industry News: NEBIDO
News Release - September 26, 2006
Indevus Announces Clinical and Regulatory Plans for PagocloneCompany to Move Forward in Phase III Trials in Stuttering
Future Work on Premature Ejaculation Not Planned After Interim Analysis of Phase II Trial Showed Insufficient Efficacy
LEXINGTON, Mass.--(HSMN NewsFeed)--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV ) today announced that following an End of Phase II meeting with the FDA, the Company has established a clinical plan towards regulatory approval of pagoclone for the treatment of persistent developmental stuttering (PDS) and will initiate a Phase III trial in the first half of 2007. Separately, following an interim analysis of the Company's Phase II trial of pagoclone in premature ejaculation (PE), the Company has chosen to discontinue the trial due to insufficient efficacy.
"The Company met with the FDA to discuss the results of our Phase II trial in adults with PDS and to explore ideas for the design and conduct of future trials," said Glenn L. Cooper, M.D., president, chief executive officer and chairman of Indevus. "Although the FDA had never considered a drug for stuttering, FDA officials were, in my opinion, extremely well-prepared and were able to give us specific and useful guidance that has allowed us to map out a clear path toward an NDA submission. Specifically, the FDA advised the Company to: 1) pursue pediatric studies in parallel with adult studies so that if pagoclone is effective and safe in both populations, the NDA could be approvable for the broadest possible stuttering population; 2) conduct the next adult and pediatric placebo-controlled trials as fixed dose-response studies to determine the minimally-effective dose; 3) pursue Phase III trials under special protocol assessments (SPAs) to allow the FDA to formally sign off on trial designs. Importantly, the FDA tentatively agreed, pending the SPA review process, to the Company's proposal on primary and secondary study endpoints and study duration."
"We are pleased to follow the guidance of the FDA and are excited to pursue pagoclone for pediatric indications sooner rather than later," continued Dr. Cooper. "There is a tremendous medical need to improve the lives of children and adolescents who stutter, as well as adults who have persistent stuttering. We are making plans to initiate a Phase III trial in adults in the first half of calendar 2007, and to conduct a small pharmacokinetic study in children to enable us to choose doses for a Phase II / III pediatric study to start later in 2007."
Results from the Phase II clinical trial in adults were announced on May 24,2006. The trial was an 8-week, placebo-controlled, double-blind, multi-center trial with an open label extension. A total of 132 patients were randomized. Results from the trial showed that pagoclone produced a statistically significant benefit in multiple primary and secondary endpoints compared to placebo. Additionally, pagoclone produced either numerically superior improvement or trends for significant improvement on virtually all other primary and secondary endpoints when compared to placebo. Pagoclone was shown to be well tolerated and not associated with any serious adverse events.
"In addition to the promising results seen in the double-blind portion of the trial," said Dr. Cooper, "the Company has been assessing the safety and efficacy of pagoclone as patients continue to receive the compound in the long term, open-label extension phase. It appears that in a significant number of patients, the magnitude of response to pagoclone increases with time, with some patients experiencing near normal fluency."
Separately, the Company elected to perform an interim analysis on an ongoing Phase II trial of pagoclone in premature ejaculation, following the recent publication in the journal Lancet of studies of the investigational drug dapoxetine in PE. Based on the high placebo response in those trials, the Company believed that the pagoclone PE study might have an inadequate sample size to detect an effect when compared to placebo, and therefore might need to be enlarged. The interim analysis revealed only a slight effect at the highest dose tested. Given the modest effect, it is unlikely that the trial would have met its clinical and statistical objectives. Accordingly, the study has been discontinued and no further work on pagoclone for PE will be performed. Dr. Cooper noted, "While we are disappointed that the interim analysis showed a lack of expected drug effect versus placebo, the drug was extremely well tolerated, and we are now able to focus our resources on moving pagoclone forward in stuttering."
Nearly 3 million Americans, or as much as 1% of the population, are afflicted with persistent stuttering, with approximately 4 times as many males being affected by the condition as females. Stuttering is a DSM-IV-TR Axis I disorder and is characterized by symptoms in which the flow of speech is disrupted by prolongations, repetitions, and blocks of sounds, syllables, words or phrases. The exact cause of stuttering is unknown; however, emerging evidence has shown that this disorder is associated with abnormalities in brain areas related to speech motor control. Stuttering most often begins in early childhood and often persists into adulthood and this form is classified as persistent developmental stuttering. Given the importance of communication in daily life, stuttering can often impair an individual's academic, social and occupational functioning. No medication is FDA approved for stuttering and the most commonly utilized treatment is speech therapy.
Pagoclone is a novel, non-benzodiazepine, GABA-A selective receptor modulator. It is part of a new chemical class of agents and lacks many of the common benzodiazepine side effects such as sedation and withdrawal. Pagoclone trials have enrolled over 1,600 patients to date. The precise mechanism of action is unknown, however, GABA is believed to be an important neurotransmitter in the brain that may be disrupted in people who stutter. Pagoclone enhances the activity in GABA circuits in the brain and thus may help restore more normal function in speech areas of the brain. In early 2005, Indevus was granted a U.S. patent directed towards the use of pagoclone for the treatment of stuttering.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products to treat urological, gynecological and men's health conditions. The Company currently co-promotes SANCTURA® for overactive bladder and markets DELATESTRYL® to treat male hypogonadism and currently has six compounds in clinical development. The compounds in clinical development include SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO® for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.
Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA® and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA, SANCTURA XR and NEBIDO®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing, marketing, and clinical trials; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; our reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
Source: Indevus Pharmaceuticals
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