TX-004HR NDA: Does TherapeuticsMD (TXMD) Have Anything to Really Worry About?

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Summary

  • TX-004HR’s 4 mcg dose may not meet the FDA’s efficacy criteria.
  • The burden of proof for the long term safety of the 10 mcg dose rests with TXMD.
  • Based on available information, it appears the NDA has a good chance of approval.

BACKGROUND

May 2017: TherapeuticsMD (TXMD) announced that the FDA had issued a Complete Response Letter (CRL) for TX-004HR (brand name: Yuvvexy; later switched to Imvexxy).

TX-004HR is a local (vaginal) softgel capsule that contains 17β-estradiol (E2). It’s indicated for the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Shortly after the CRL, TXMD issued a press release and an 8-K to affirm that the only approvability-related concern in the CRL was a lack of long-term endometrial safety data beyond the pivotal 12 week trial; likely because TX-004HR is a novel dosage form.

In the CRL, the only approvability concern raised by the FDA was the lack of long-term endometrial safety data for TX-004HR beyond the 12 weeks studied in the pivotal phase 3 Rejoice Trial. No cases of endometrial hyperplasia were observed in the Rejoice Trial at the end of week 12 for all the doses studied and included in the NDA.

However their 10-K statement on the point was broader, and mentioned the need for additional (unqualified) long-term safety data.

In the CRL, the only approvability concern raised by the FDA was the lack of long-term safety data for TX-004HR beyond the 12 weeks studied in the phase 3 REJOICE Trial.

This could’ve been because the press release and 8-K were put forth shortly after the CRL, while the 10-K was issued after numerous discussions with the FDA post-CRL. Discussions that appear to have raised additional long-term safety concerns.

DISCUSSIONS WITH THE FDA

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Published: 4/8/2018

Last Updated: 5/13/2018 for elements of style. 5/30/2018 – added Imvexxy as the new brand name.

No one associated with writing this article has any financial stake in, or ties to, TXMD.

2018-12-05T16:12:30+00:00