Healthcare Industry News: persistent developmental stuttering
News Release - March 7, 2006
Indevus Files New Patent Application for the Use of Pagoclone in Premature EjaculationLEXINGTON, Mass.--(HSMN NewsFeed)--March 7, 2006--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV ) today announced that it has filed a New Patent Application with the U.S. Patent Office covering the use of pagoclone as a treatment for premature ejaculation (PE). The patent filing is based on evidence of pharmacologic activity contained in the Company's existing clinical databases.
"Premature ejaculation is one of the most common sexual dysfunctions in men, affecting approximately 30% of the adult male population," stated Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "There are currently no approved oral drugs in the United States for the treatment of PE. The normal ejaculatory response is controlled by multiple neurotransmitters, including serotonin and GABA. There is evidence that drugs that stimulate or increase the levels of GABA in the brain may delay the ejaculatory response."
"Pagoclone is a selective, non-sedating GABA-A receptor partial agonist, studied extensively in the past for anxiety disorders and currently being studied by Indevus in a Phase II trial for the treatment of stuttering," continued Dr. Cooper. "We have found evidence within our existing database that patients have described ejaculatory delay on pagoclone. Based on these observations and the pharmacologic rationale, we intend to form an internal project team to explore the clinical and regulatory path to proof of concept studies of pagoclone as an on-demand oral therapy for men with PE. Pagoclone for PE would be an excellent strategic addition to our urology and men's health franchise."
Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor partial agonist. In clinical studies in anxiety disorders, it has been shown to reduce the symptoms of panic disorder and generalized anxiety disorder without causing the sedation or withdrawal effects seen with benzodiazepine agents. Pagoclone trials have enrolled over 1,600 patients to date. In early 2005, Indevus was granted a new U.S. patent covering the use of pagoclone for the treatment of stuttering. The Company recently completed enrollment in an approximately 130 patient Phase II clinical trial to study pagoclone for the treatment of persistent developmental stuttering. The Company expects to report results of this trial in mid-June of 2006.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology, gynecology and men's health. The Company currently markets SANCTURA® for overactive bladder and DELATESTRYL® for the treatment of male hypogonadism. The Company has multiple compounds in clinical development, including 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 and marketing; 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; limited patent 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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