FDA Panel Votes Down Novel Testosterone Therapy, Favors Restricting Similar Drugs

On the heels of its recommendation to limit the use of testosterone replacement drugs due to potential cardiovascular risks, an FDA advisory panel overwhelmingly voted to reject the new drug application for Clarus Therapeutics’ novel oral testosterone candidate, Rextoro.

On September 18, 2014, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-3 that the overall benefit-risk profile of Rextoro is not sufficient enough to support its approval. The advisory panel also voted 12-8 with 1 abstention that there is not sufficient evidence to support the testosterone capsule’s efficacy in men with hypogonadism.

In a press release that trailed those decisions, Robert E. Dudley, PhD, chief executive officer of Clarus Therapeutics, stated, “We strongly believe the clinical data we presented demonstrate the safety and efficacy of Rextoro and are consistent with other testosterone replacement products that have been approved by the FDA.”

One day earlier, however, the FDA panel voted in favor of restricting the use of those products to men with medically related hypogonadism, as well as requiring additional randomized controlled trials to assess the drugs’ cardiovascular risk in those with age-related low testosterone.

According to Reuters, officials for AbbVie Inc, the maker of market leader AndroGel, argued that there is no evidence of a causal association between testosterone therapies and cardiovascular risk. Nevertheless, the company said it would be willing to discuss drug label changes.

Although the FDA is not bound to follow the recommendations of its advisory committees, the agency typically does so.