Endo’s testosterone gel Fortesta to enhance sexual libido in men needs more data: US FDA

Testosterone gel Fortesta to enhance sexual libido in testostrone deficient men by Endo Pharmaceuticals Holdings Inc has been delayed approval in US.

Fortesta which contains testosterone 2 per cent gel form for men diagnosed with low testosterone (Low T), also known as hypogonadism has been submitted to US FDA for regulatory review.

Endo Pharmaceuticals received a complete response letter from the U.S. Food and Drug Administration regarding the New Drug Application (NDA) seeking more information on Fortesta testosterone gel.

In August 2009, Endo signed an agreement with UK-based ProStrakan Group Plc to acquire exclusive US rights to commercialize the testosterone 2% gel, branded variously as Tostran, Tostrex and Itnogen outside the US.

The testosterone 2% gel is marketed across Europe by ProStrakan’s own, in-house sales forces and is out-licensed by ProStrakan to Bayer Schering Pharma (BSP) in 147 countries.

In August, Endo Pharma’s another testosterone formulation for men 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.

Nebido was licensed by Bayer Schering Pharma to Indevus Pharmaceuticals, a company that Endo acquired earlier this year.

Endo Pharma 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).

Endo Pharmaceutical’s 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; Frova tablets for the acute treatment of migraine attacks with or without aura in adults; Opana tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; Opana ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; Voltaren Gel, which is owned and licensed by Novartis AG, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as those of the hands and the knees; Vantas for the palliative treatment of advanced prostate cancer; Supprellin LA for the treatment of early onset puberty in children; and Valstar for the treatment of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable medical risks.

Endo Pharma markets its branded pharmaceutical products to physicians in pain management, urology, endocrinology, oncology, neurology, surgery and primary care.