FDA Approves Endo's Aveed Testosterone Replacement For Male Hypogonadism
By Cyndi Root
Endo International announced in a press release that the Food and Drug Administration (FDA) has approved the Aveed injection. Aveed (testosterone undecanoate) is indicated for adult men with hypogonadism. The prescription medicine will be available immediately, but only through the Aveed Risk Evaluation and Mitigation Strategy (REMS) Program. Rajiv De Silva, president and chief executive officer of Endo, said, "With Aveed, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels.”
Male Hypogonadism, also called Low T, is a condition affecting males wherein the gonads (testes) produce an insufficient amount of testosterone. This hormone deficiency is responsible for decreases in cognition, sexual performance, and a host of other deficits. Men may lose weight, lose muscle, and become infertile. Primary hypogonadism starts in the testicles, while secondary hypogonadism originates in the hypothalamus or the pituitary gland. Hypogonadism is inherited or may be acquired due to infection or injury.
Aveed (testosterone undecanoate) is a testosterone injection. The new medication is a 3-mL (750 mg) intramuscular injection given three times in the first ten weeks, once at treatment initiation, once at four weeks, and once at ten weeks. Every ten weeks thereafter, the patient receives an injection. Patients must receive the injection in a physician’s office or hospital. Interested patients or healthcare providers can learn about the Aveed Risk Evaluation and Mitigation Strategy (REMS) Program by calling 1-855-755-0494 or visiting the website at www.AveedREMS.com.
Aveed Clinical Trials
Endo conducted clinical trials, which the FDA reviewed for the approval. The 18 trials included over 3,000 men. A Phase III trial in the U.S. enrolled hypogonadal men in an 84-week trial. The average age was 54 years of age and the average serum testosterone level was less than 300 ng/dL. Investigators proved that Aveed raised testosterone levels and maintained levels through 24 weeks.
Endo Pharmaceuticals Inc. is the operating company based in Malvern, PA for Endo International plc based in Dublin, Ireland. Endo licensed Aveed from Bayer Pharma AG who has been marketing testosterone since 2003. Endo develops drugs for pain and cancer including Lidoderm, Percocet, Frova, Opana, and Vantas.