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94 Percent of Men Maintained Normal Testosterone Levels Throughout Treatment. 92 Percent of Men Expressed Satisfaction with NEBIDO
LEXINGTON, MA, USA | May 20, 2008 | Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that data on NEBIDO(R) (testosterone undecanoate), an investigational, long-acting intramuscular injection for the treatment of hypogonadism, was presented in a late breaker presentation at the 2008 American Urological Association Annual Meeting held in Orlando. The data, which had been previously announced, are based on a Phase III study in which men with hypogonadism and low serum testosterone levels prior to entering the study were treated with NEBIDO for 24 weeks. This study demonstrated that 94 percent of the men had their testosterone levels restored and maintained to within normal levels; further, 92 percent of these men expressed satisfaction with their NEBIDO treatment. Sixty-two percent of men participating in the Phase III study had previously used other testosterone treatments.
"An estimated four to five million men in the U.S. suffer from a common but treatable condition called hypogonadism, or low testosterone. Men with this condition experience decreased libido, fatigue, depression, and muscle loss," said Abraham Morgentaler, MD, Associate Clinical Professor of Urology at Harvard Medical School. "Low testosterone is associated with other significant health issues including diabetes, obesity, cardiovascular disease, and osteoporosis. Low testosterone is under-recognized and under-treated. Results of a Phase III study on a long-acting testosterone injection called testosterone undecanoate (NEBIDO) revealed that a very high percentage of men who received this treatment maintained normal testosterone levels while receiving an injection every 10 weeks. This form of testosterone treatment would thus require only five injections per year. This would be an appealing alternative for many men, who may object to existing testosterone treatments such as twice-monthly injections or daily skin application of gels or patches."
About the Study
This Phase III study was a multi-center, open-label, randomized US trial designed to assess the pharmacokinetics, safety, and efficacy of NEBIDO in men with primary or secondary hypogonadism. The trial enrolled a total of 130 hypogonadal men (serum testosterone below 300 ng/dL, at least 18 years of age) that met the study inclusion criteria. Patients received injections of 750 mg of NEBIDO at baseline, week 4, and week 14 of the study, and were followed for an additional 10 weeks. Of the 130 men who participated in the trial, 117 patients were eligible for pharmacokinetics evaluations.
In the study, pharmacokinetic objectives were achieved, with 94 percent of patients reaching and maintaining normal serum testosterone levels. Additionally, secondary endpoints of mood and sexual function also improved. The most commonly reported possibly-related adverse events in the trial were acne (4.6 percent), fatigue (3.1 percent), and injection site pain (3.1 percent).
About NEBIDO
NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.
About Hypogonadism
Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Today, there are an estimated four to five million men in the U.S. who suffer from hypogonadism. Of this group, less than ten percent are currently receiving treatment with testosterone therapy.
About Indevus
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, the octreotide implant for acromegaly, and a biodegradable ureteral stent used in association with the adjunctive treatment of kidney stones.
SOURCE : Indevus Pharmaceuticals, Inc. |
