Eli Lilly get FDA approval for “under-arm” testosterone supplement


According to a media release issued just before Thanksgiving, the FDA has approved a new formulation of testosterone supplement (originally developed by an Australian company called Acrux) and licensed to Eli Lilly & Co. for marketing in the USA and the rest of the world.

The use of testosterone supplements by men previously diagnosed with prostate cancer and other prostate disorders is more than a little controversial.  Indeed, the prescribing information for this new formulation, with the brand name Axiron®, includes very specific warnings about use of testosterone by men with a history of prostate cancer, at known risk for prostate cancer, or who have benign prostatic hypertrophy (BPH). Having said that, there are certainly patients who have testosterone deficiency after long-term hormone therapy who have successfully used testosterone supplements to regain physical vigor and sexual capabilities.

We had previously joked that Axiron would be available as a “roll on” underarm formulation (like a roll on deodorant). In fact, Axiron is supplied as a “pumped” formulation, with a specific amount of product to be administered under each armpit once a day using an applicator. The amount of product to be used can be varied based on a physician’s prescription but does need to be very strictly controlled and applied.

Obviously the use of testosterone supplementation by any prostate cancer patient needs to be managed with great care and caution, and preferably under the supervision of a physician who has some experience of the use of testosterone supplements in patients with prostate cancer. There is no form of testosterone supplement that has ever been approved by the FDA (or any other regulatory agency that we are aware of) for the management of low testosterone levels in men with prostate cancer.

2 Responses

  1. “There is no form of testosterone supplement that has ever been approved by the FDA (or any other regulatory agency that we are aware of) for the management of low testosterone levels in men with prostate cancer.”

    Has the FDA denied proposed T-supplements for PCa patients or has the potential for T-supplementation simply been ignored due to the effects of testosterone on PCa and general lack of interest in QoL issues by the industry?

  2. Dear Tracy:

    The FDA does not make decisions about the treatment of patients with specific drugs. It decides exclusively whether specific drugs should be marketed for defined indications. It makes those decisions on the basis of applications from drug manufacturers and other available data. Once a specific drug is available for prescription, any physician can prescribe it for any condition her or she likes. Sometimes the FDA withdraws drugs from the market because new data suggests that the risks associated with use do the drug may or do outweigh any benefit.

    The reason why there is limited use of testosterone supplements for patients with prostate cancer is that it is potentially dangerous. Testosterone is a hormone that drives growth of prostate cancer. What is not clear is whether, in carefully selected patients, we can balance the treatment of the cancer against the risk of cancer growth using testosterone supplements. This has been done in some patients, but there is most certainly evidence from others demonstrating that testosterone supplementation can have very serious impact on prostate cancer recurrence and growth.

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