On Monday, TherapeuticsMD Inc TXMD received a Complete Response Letter from the FDA related to the company’s New Drug Application for TX-004HR. TX-004HR is a applicator-free estradiol vaginal softgel capsule used to treat moderate-to-severe sexual intercourse pain caused by vulvar and vaginal atrophy due to menopause.
FDA Letter
In the letter the FDA revealed that its only concern related to TX-004HR is the lack of long-term endrometrial safety data from TherapeuticsMD’s Phase III Rejoice Trial.
TherapeuticsMD shares plummeted 10.4 percent on Monday as the market reflected disappointment that TX-004HR was not granted approval by the FDA.
“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,” CEO Robert Finizio said in a statement.
Best Possible Results Short Of An Approval
According to Cantor Fitzgerald analyst William Tanner, the complaint in the FDA letter was the best news shareholders could get short of an approval. Tanner says any issues with the clinical trial process or data collection methods or any concerns with the efficacy of the drug would have been major issues, but the FDA had no such concerns.
“We believe it a non-zero probability that they may not require the study at all, and we believe there is a far-higher probability that the long-term safety study could be conducted as a post-approval commitment,” Tanner explained.
After speaking with an ob/gyn consultant, Cantor Fitzgerald remains…
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