Shares of TherapeuticsMD have shot up more than 51 percent in morning trading after the FDA reversed course on its rejection of that company’s vaginal pain medication.
Shares of TherapeuticsMD, Inc. have shot up more than 51 percent in morning trading after the U.S. Food and Drug Administration reversed course on its rejection of that company’s vaginal pain medication.
On Friday, the FDA gave the company permission to resubmit its New Drug Application for TX-004HR without the need for an additional pre-approval study. This morning TherapeuticsMD said it intends to resubmit its NDA to the FDA in the next few weeks. In its announcement, TherapeuticsMD said it will commit to conducting a post-approval observational study.
In May, the FDA issued a Complete Response Letter for TherapeuticsMD’s experimental drug. TX-004HR, is an applicator-free estradiol vaginal softgel capsule developed to treat moderate-to-severe vaginal pain during sexual intercourse, a symptom of vulvar and vaginal atrophy (VVA) due to menopause. In its rejection of TX-004HR, the FDA raised concern over the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal Phase III trial.
The reversal marks the third time this year the FDA has changed course on a drug it previously rejected over safety concerns. Each reversal came after new FDA Commissioner Scott Gottlieb took over the reins of the agency. Gottlieb, along with President Donald Trump, has indicated a need for streamlining the regulatory process.
In July, the regulatory agency first reversed course on Amicus Therapeutics’ Phase III treatment for Fabry disease. The change paves the way for Amicus to seek regulatory approval later this year. In November 2016, the FDA stunned Amicus when it called for a new clinical trial for its lead drug candidate migalastat, also known as Galafold in Europe, in order to win regulatory approval. The FDA was interested in additional safety data and sought a 35-patient trial seeking additional data on gastrointestinal (GI) symptoms in Fabry patients who have an amenable mutation. That was expected to delay Amicus by about three years, but the FDA reversal cleared the way for a redo.
The second company to receive a new chance to resubmit a previously rejected drug was Eli Lilly. In April, the FDA rejected rheumatoid arthritis drug baricitinib. The agency said it wanted more clinical data on dosing, as well as more data to address broader safety concerns. Those concerns turned out to be over blood clots. However in August, Lilly said it will resubmit its NDA for baricitinib by the end of January 2018.
Now TherapeuticsMD is getting a second chance. But its vaginal pain treatment won’t be the only NDA submitted to the FDA. The company said it will submit the NDA for its hormone therapy treatment TX-001HR by the end of December. The investigational drug is being developed for the treatment of moderate-to-severe vasomotor symptoms due to menopause.
“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,” TherapeuticsMD Chief Executive Officer Robert Finizio said in a statement.
Shares of TherapeuticsMD hit a morning high of $6.78, but has dropped back to $6.25 as of 10:53 a.m.
