Sufferers of male hypogonadism may soon be offered some respite, with the Food and Drug Association (FDA) finally approving testosterone-replacement drug, Aveed, after knocking back three separate applications for approval.
Endo Pharmaceuticals Inc, manufacturers of Endo, welcomed the decision. "Today's FDA approval of AVEED is a significant milestone for Endo. AVEED expands our branded portfolio of men's health products and highlights our passion and commitment to providing high quality therapies that improve patient care," said Rajiv De Silva, president and chief executive officer of Endo, to the Wall Street Journal. "With AVEED, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels. We are focused on getting AVEED to market to ensure that appropriate patients have access to it."
The condition, characterized by lower than average production of testosterone, can lead to stunted bone and muscle growth as well as poor sexual function. As a result, sufferers often experience depression, fatigue, and minimal libido. Advancements in treatment have been hampered by adverse side effects of proposed drugs, with Aveed and its ilk though to carry a high risk of heart problems. The FDA had previously nixed Aveed's application for approval based on the inclusion of castor oil in the drug, which could cause blood vessel blockages in the lungs and side effects from the injections.
Aveed comes in the form of an intramuscular injection, which is then followed up after four weeks. Continued treatments occur every ten weeks thereafter. It will also carry a boxed warning - the most severe of its kind - against serious pulmonary oil microembolism (POME) reactions and anaphylaxis, only to be used by patients for whom the results would outweigh the risk.
Despite the possibility of adverse reactions in some patients, Aveed has nevertheless been lauded as a viable option for management of hypogonadism. "Men's Health Network is pleased to see the FDA approval of a new treatment for hypogonadism as we believe men with this condition should have access to a broad range of treatment options," said Ana Fadich, MPH, vice president of the Men's Health Network. "Men diagnosed with hypogonadism and their partners need to have an open discussion, with each other and the man's doctor, about the condition and ways to manage it so they can find the right treatment that best suits their individual needs."
