The FDA has acknowledged that the resubmission is a complete, class 2 response to the CRL received on May 5, 2017 for TX-004HR.
On May 8, 2017, the U.S. Food and Drug Administration (FDA) rejected TherapeuticsMD’s New Drug Application (NDA) for TX-004HR. The compound is an applicator-free estradiol vaginal softgel capsule to treat moderate-to-severe vaginal pain during sexual intercourse (dyspareunia). This is a symptom of vulvar and vaginal atrophy (VVA) related to menopause. The agency’s Complete Response Letter (CRL)’s only concern was long-term endometrial safety data past the Phase III study’s 12 weeks. No safety issues were observed.
Earlier this week, TherapeuticsMD announced that the FDA had accepted its resubmission for TX-004HR. Surprisingly, company shares dropped 7 percent in premarket trading after the announcement. Why?
Because the FDA classified the resubmission as a “class 2 response” instead of a “class 1 response.” A class 1 response would have given the drug a two-month timeline for approval, while the class 2 response gives it a six-month timeline. That means instead of approval in January or February, its PDUFA date is May 29, 2018.
Per TherapeuticsMD’s statement, “The FDA has informed the Company that the additional endometrial safety information submitted to the NDA for TX-004HR on September 14, 2017 was outside of an official review cycle, thus procedurally designating a class 2 response. The Company currently plans to launch TX-004HR in the third quarter of 2018 if approval occurs on or before the PDUFA target action date.”
Annabel Samimy, an analyst with Stifel, wrote in a note, “The wait continues,” adding “we continue to believe in the approvability of TX-004HR.”
The original submission, which included data from the Phase III Rejoice Trial, evaluated the effectiveness of three doses of TX-004HR compared to placebo from baseline to 12 weeks. It showed statistically significant and clinically meaningful improvements in dyspareunia—pain during intercourse—and vaginal dryness. Significant effects were observed as early as two weeks of treatment.
“The acceptance of the NDA resubmission for TX-004HR is an important milestone for TherapeuticsMD and this PDUFA target action date will allow us to maintain our timelines for launch as early as July 2018,” Robert Finizio, the company’s chief executive officer, said in a statement. “If approved, TX-004HR has the potential to be a highly differentiated treatment option for the 32 million postmenopausal women in the United States who suffer from symptoms of VVA.”
TherapeuticsMD focuses on women’s health. It markets vitaMedMD Rx, prescription prenatal vitamins, and BocaGreenMD, generic prescription prenatal vitamins. It has a pipeline of novel hormone therapies that uses its SYMBODA technology. In addition to TX-004HR, it has TX-001HR, an oral combination of estradiol and progesterone, TX-005HR, a transdermal progesterone, and TX-006HR, a transdermal estradiol-progesterone.
On Nov. 3, at its third-quarter financial report, the company reported that for the quarter, its prescription prenatal vitamin business brought in $4.4 million, compared to $5.5 million from the same quarter the previous year. Net loss was about $14.7 million for the quarter, compared to $25 million from the previous year.
“We continue to focus on advancing our pipeline of novel hormone therapies and, if approved, bringing new, differentiated treatment options to women suffering from symptoms of menopause,” Finizio said in a statement.
