FDA Panel Denies Clarus Therapeutics' Oral Testosterone Drug Rextoro

FDA Panel Denies Clarus Therapeutics' Oral Testosterone Drug Rextoro

September 19, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

The U.S. Food and Drug Administration has shot down private company Clarus Therapeutics’ oral testosterone drug Rextoro, saying Thursday that the company had not done enough to allay fears that testosterone therapy can lead to elevated risks of heart attack and other cardiovascular events.

The FDA's urologic and drug safety committees voted 18-3 with one abstention to deny Clarus’s application for approval for the drug, saying the company had provided incomplete data from the drug's two Phase III trials. The FDA’s final decision on Rextoro’s fate is due by Nov. 3.

However, the FDA panels did say that given the information it had, Rextoro didn't seem any more dangerous than other so-called “low-T” drugs, though its use as an oral therapy did carry some risk of overdose.

Low testosterone therapies have been in the crosshairs lately, because of increasing evidence the drugs can cause an elevated risk of cardiac events. Earlier in the week, a separate panel at the FDA voted 14-1 in favor of restricting low-T drugs to specific medical conditions. Currently they can be prescribed for any medical complaint.

The move is likely to torpedo Clarus’s initial public offering hopes, after it attempts a second bite at the public market apple since withdrawing an IPO bid in 2011. Rextoro had been the company’s best hope for garnering investor interest and capital, after a potential $86 million IPO earlier this year fell through.

Clarus raised $31.5 million in promissory notes in June as it attempts to fund its future until wider regulatory approvals can be obtained.

The company said it would be resubmitting the drug in the near future. "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," said Robert Dudley, chief executive officer, Clarus Therapeutics, 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."

In two Phase 3 trials, REXTORO met its primary endpoint of restoring testosterone to normal levels in at least 75 percent of subjects1 and demonstrated efficacy similar to currently approved treatments. Low testosterone, or hypogonadism, is a condition characterized by insufficient testosterone production. Symptoms include reduced sexual activity and desire, decreased energy, increased body fat and reduced muscle mass and depression.

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