Libido boosting testosterone injection Aveed by Endo requires more safety data: US FDA

Long acting version of testosterone undecanoate injection Aveed to boost the sexual libido in men needs more data to establish its safety, US FDA has said to Endo Pharmaceuticals, the developer of the drug.

The extended-duration testosterone undecanoate injection Aveed is currently has been approved 86 countries worldwide and marketed under the brand name Nebido in more than 50 countries across Europe, Asia Pacific and Latin America to treat men suffering from low sexula libido or hypogonadism.

Aveed was licensed from Bayer Schering Pharma AG, Germany to Indevus Pharmaceuticals, a company Endo acquired earlier this year. Nebido, discovered and developed by Bayer Schering Pharma.

US FDA has requested more data from Endo to address its concerns regarding very rare but serious adverse events reported in men using testosterone undecanoate injection.

These adverse reactions include post-injection anaphylactic reaction and pulmonary oil microembolism.

The US FDA letter also specified that the proposed Risk Evaluation and Mitigation Strategy (REMS) for testosterone undecanoate injection Aveed is not sufficient.

Endo Pharmaceuticals, which has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection Aveed, is currently evaluating the letter, the company announced in a press release.

In August, Aveed’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.

Similarly, in October, US FDA delayed approval for Endo’s testosterone gel Fortesta to enhance sexual libido in testosterone deficient men.

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.

What’s hypogonadism?

Hypogonadism, or deficiency of the sex hormone testosterone in men, is a condition  characterized by the body’s failure to produce normal amounts of the hormone testosterone. It is associated with symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction.

Low testosterone activity in men is also linked with other serious medical conditions including diabetes, cardiovascular disease and metabolic syndrome.

Because the symptoms of low testosterone are often similar to those caused by other medical conditions, more than 91 percent of men with the condition go undiagnosed.

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.