Drug Development

Nixed by the FDA, TherapeuticsMD is now planning a long-shot bid to reverse the decision

Robert G. Finizio

TherapeuticsMD already flagged that the FDA was about to reject its application for TX-004HR, a proposed new therapy to treat vaginal pain during intercourse for women with vulvar and vaginal atrophy triggered by menopause. Today it confirmed that the agency has indeed nixed the treatment, and it’s preparing a rebuttal case to see if they can turn it around.

That’s doubtful, as the FDA rarely reverses course once regulators have made up their minds — though it can happen.

In this case, though, TherapeuticsMD {TXMD} already faces rivals on the market, undercutting any argument it could make on unmet medical need. We don’t have the CRL, as the FDA doesn’t publish those, but the Boca Raton, FL-based company says that the regulators’ sole concern was lack of longterm data on endometrial safety beyond the 12 weeks it has in the Phase III.

They don’t agree.

The Company believes that the NDA was approvable as filed and intends to meet with the FDA as soon as possible to address the concerns raised by the FDA.

If the FDA sticks with its demand, TherapeuticsMD would have to launch a new trial which would significantly delay any return to the agency.

TherapeuticsMD started the day with a market cap at $952 million. The stock dropped about 10% as investors got a better idea of what was tripping the company up.

“While we are disappointed that the NDA for TX-004HR was not approved at this time and respectfully disagree with the FDA’s decision, we believe there are multiple paths forward to address the concerns raised by the FDA. The FDA has encouraged us to request a meeting to discuss our path forward and we intend to meet with the FDA as quickly as possible,” said TherapeuticsMD CEO Robert G. Finizio. “We are also continuing to prepare the NDA for TX-001HR, our investigational oral bio-identical combination of estradiol and progesterone, and anticipate that we will submit that NDA to the FDA as early as the third quarter of 2017.”

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