Nebido, a testosterone drug for men with low sexual drive from Endo Pharma, has been delayed for approval in US.
Testosterone treatment Nebido’s review date has been extended by three months by the U.S. Food and Drug Administration. USFDA, however, did not request for additional data, said Endo Pharmaceuticals Holdings Inc in an official release.
US FDA extended the review date for Nebido from Sept. 2 to Dec. 2 and has stated that it needs more time to complete its review of the application and finalize the risk evaluation and mitigation strategy (REMS) for the long acting version undecanoate of the testosterone product.
Nebido is already approved outside the United States as a treatment for hypogonadism or low testosterone .
Nebido, discovered and developed by Bayer Schering Pharma AG, Germany, has subsequently been approved in 86 countries worldwide and is available in more than 50 countries across Europe, Asia Pacific and Latin America.
“Our goal is to make this significant new treatment option available to the millions of men in the U.S. suffering from low testosterone,” stated David Holveck, president and chief executive officer of Endo Pharmaceuticals.
Nebido was licensed by Bayer Schering Pharma to Indevus Pharmaceuticals, a company that Endo acquired earlier this year.
An estimated 13.8 million American men have testosterone levels characterized as below normal (testosterone <300ng/dl). Yet despite this high prevalence, only about 9 percent of men with low testosterone are treated with testosterone replacement therapy. Low testosterone or hypogonadism is a common yet largely under-recognized and under-treated condition.
Manifesting symptoms of low testosterone include oad range of physical, psychological and sexual symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction.
Low testosterone levels in men is also associated with serious medical conditions including diabetes, cardiovascular disease and metabolic syndrome.
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, overactive bladder, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP). Its products include Lidoderm, a topical patch to relieve the pain of postherpetic neuralgia; Percocet and Percodan tablets for the relief of moderate-to-moderately severe pain.
Endo’s Frova tablets are used for the acute treatment of migraine attacks with or without aura in adults and Supprelin LA for the
treatment of early onset puberty in children. Endo markets its branded pharmaceutical products in pain management, neurology, surgery, oncology, endocrinology and primary care.