FDA, Setbacks

The FDA still hates low T drugs — experts bat back a pair of contenders

The FDA isn’t relenting on its skeptical attitude toward new testosterone therapies. And neither are the experts that advise the agency on new drug applications in the field.

Mahesh Patel

Lipocine is the latest biotech to feel the whip as an FDA advisory panel voted 13 to 6 against recommending an approval for Tlando, an oral drug that was designed to replace the gels that have been available. And its shares $LPCN cratered on the shutout, dropping 58% after the vote came down.

The rejection came one day after the FDA also shot down a try by Clarus Therapeutics to get an endorsement for Jatenzo after it was batted back in 2014.

Douglas Bauer

“I voted ‘no’ because … the indication is the same as the existing preparations and we know there is huge off-label use,” noted committee member Douglas Bauer of the University of California San Francisco, in a report from MedPage Today. “I think that’s unacceptable, and I don’t think that the sponsor’s proposals to try to change that, frankly, are likely to be very successful.”

Low T drugs have been in disfavor at the agency, where the feds have been worried about the side effects associated with testosterone therapies and the potential for misuse. Several years ago regulators began to raise the bar on the use of therapies for low testosterone, looking to restrict their use to certain medical conditions as opposed to providing a boost for men.

Repros was among the first to feel the change of regulatory attitudes with the 2015 rejection of Androxal. That ailing biotech shifted focus for uterine fibroid therapy and was bought out last month by Allergan at 67 cents a share.

“We continue to believe that efficacy and safety results from numerous clinical studies with TLANDO are consistent with other FDA approved TRT products,” said Lipocine CEO Mahesh Patel.  “We look forward to continuing to work with the FDA through the remainder of the review process.”

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