FDA advisers shoot down Clarus' pitch for a new low-T drug

Amid widespread safety concerns surrounding testosterone drugs, an FDA panel has recommended against Clarus Therapeutics' oral treatment, dimming the future for the company's sole product.

In a joint meeting of the FDA's urologic and drug safety committees, advisers voted 18-3 against approving Clarus' treatment, Rextoro, raising serious concerns with the company's pivotal data.

The group voted 12-8 with one abstention that Rextoro failed to prove itself effective, chiding Clarus for turning in incomplete data from the drug's two Phase III trials. On the safety side, panelists noted that Rextoro didn't seem any more dangerous than other so-called low-T drugs, but, because it's an oral treatment, patients may be prone to taking more of it, putting them at greater risk of the cardiovascular events tied to the whole class.

The FDA is not beholden to follow the votes of its advisers, though it most often does. A final decision on Rextoro is due by Nov. 3.

Meanwhile, the agency has zeroed in on low-T treatments, taking a hard look at mounting evidence that testosterone therapy can lead to elevated risks of heart attack and other events. On Wednesday, a separate panel voted 14-1 in favor of restricting such drugs to use in specific medical conditions; currently, they're widely prescribed to men reporting low testosterone levels.

The recent outpouring of concern over the safety of testosterone drugs certainly didn't help Clarus' case before FDA advisers, but the panel presented plenty of Rextoro-specific criticisms that would likely have complicated its pitch no matter the circumstance.

Despite the setback, however, Clarus remains all-in on its low-T treatment. After submitting Rextoro for agency review in January, the biotech floated the idea of an $86 million IPO to cover the drug's eventual launch, but those plans eventually fell by the wayside, and, in June, Clarus raised $31.5 million in promissory notes to fund its future.

Clarus CEO Robert Dudley

"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," CEO Robert Dudley said in a statement. "We will work closely with the FDA to respond to the panel's concerns and remain committed to bringing Rextoro to the market as soon as possible."

- read the release

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