The Food and Drug Administration (FDA) has approved a new long-lasting testosterone treatment for men despite protests from consumer watchdog Public Citizen to delay it’s decision until the agency has had a chance to review studies that show testosterone replacement therapy increases the risk of heart attacks, strokes and death.
The new treatment, AVEED, made by Endo Pharmaceuticals, is an injection that is administered as a single 3mL (750 mg) intramuscular injection given once at initiation of therapy, at four weeks, and then every 10 weeks thereafter. It will be available as a prescription this month.
The drug is intended for adult men with hypogonadism, commonly known as Low T. The approval is based on data from an 84-week Phase 3 trial of men with an average age of 54 with an average serum total testosterone level of less than 300 ng/dL.
AVEED has been sold in other countries under the brand name Nebido. This is the third time the drug has been reviewed by the FDA. Previously, the treatment was rejected based on concerns over injection site reactions and blockages in the blood vessels in the lungs.
Recent studies have shown that currently marketed testosterone treatments, such as AndroGel, Testim, and Axiron, can increase the risk of cardiovascular events and death by nearly a third in older men.
AVEED was approved with a Risk Evaluation and Mitigation System (REMS), a process that requires drug makers to conduct studies to ensure the benefits of the product outweigh the risks.