FDA News

Long-term safety data needed for investigational estradiol vaginal softgel capsule

TherapeuticsMD recently received a Complete Response Letter from the FDA in reply to its New Drug Application for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate to severe vaginal pain during sexual intercourse, according to a company press release.

The letter cited a lack of long-term endometrial safety data for TX-004HR after the 12 weeks studied in the phase 3 REJOICE trial. At the end of week 12, no cases of endometrial hyperplasia were reported. No issues related to the efficacy of TX-004HR or chemistry, manufacturing or controls were identified in the letter.

TherapeuticsMD noted that it plans to meet with the FDA as soon as possible to address the concerns raised in the letter.

“While we are disappointed that the NDA for TX-004HR was not approved at this time and [we] respectfully disagree with the FDA’s decision, we believe there are multiple paths forward to address the concerns raised by the FDA,” Robert G. Finizio, CEO of TherapeuticsMD, said in the release. “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. We are also continuing to prepare the NDA for TX-001HR, our investigational oral bioidentical combination of estradiol and progesterone, and anticipate that we will submit that NDA to the FDA as early as the third quarter of 2017.”

TherapeuticsMD recently received a Complete Response Letter from the FDA in reply to its New Drug Application for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate to severe vaginal pain during sexual intercourse, according to a company press release.

The letter cited a lack of long-term endometrial safety data for TX-004HR after the 12 weeks studied in the phase 3 REJOICE trial. At the end of week 12, no cases of endometrial hyperplasia were reported. No issues related to the efficacy of TX-004HR or chemistry, manufacturing or controls were identified in the letter.

TherapeuticsMD noted that it plans to meet with the FDA as soon as possible to address the concerns raised in the letter.

“While we are disappointed that the NDA for TX-004HR was not approved at this time and [we] respectfully disagree with the FDA’s decision, we believe there are multiple paths forward to address the concerns raised by the FDA,” Robert G. Finizio, CEO of TherapeuticsMD, said in the release. “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. We are also continuing to prepare the NDA for TX-001HR, our investigational oral bioidentical combination of estradiol and progesterone, and anticipate that we will submit that NDA to the FDA as early as the third quarter of 2017.”