TherapeuticsMD Inc. (NYSEMKT: TXMD) was leading the health care sector in Tuesday’s session on positive top-line results from one of its late-stage trials. The company announced positive results from its pivotal Phase 3 Rejoice Trial of TX-004HR, an investigational, applicator-free vaginal estradiol softgel, for the treatment of moderate to severe dyspareunia.

For some background, dyspareunia is vaginal pain during sexual intercourse, a symptom of vulvar and vaginal atrophy (VVA) due to menopause. VVA is a chronic condition affecting nearly half of postmenopausal women in the United States that can significantly impair their quality of life.

Safety and efficacy analyses of the Rejoice Trial data are ongoing. TherapeuticsMD plans to submit Rejoice Trial results for presentation at future scientific meetings and for publication in peer-reviewed journals.

Robert G. Finizio, CEO of TherapeuticsMD, said:

We are extremely encouraged that all three doses of TX-004HR studied in the Rejoice Trial demonstrated positive results. With efficacy observed as early as two weeks and the convenience of the applicator-free vaginal softgel, we believe that, if approved, TX-004HR has the potential to offer a highly differentiated, new treatment option that meets the needs of the millions of postmenopausal women with VVA who are suffering from pain during sexual intercourse. We look forward to sharing the Rejoice Trial results and to submitting a New Drug Application for TX-004HR to the Food and Drug Administration as soon as the first half of 2016.

Sebastian Mirkin, M.D., Chief Medical Officer of TherapeuticsMD, added:

Nearly half of all postmenopausal women have VVA, yet few are treated with prescription therapy. The highly statistically significant efficacy results and safety profile from the Rejoice Trial are very promising. We are excited about the potential for TX-004HR to be a new treatment option with low systemic absorption for women with VVA suffering from moderate to severe dyspareunia.

Shares of TherapeuticsMD were last seen trading up over 45% at $9.62, with a consensus analyst price target of $17.40 and a 52-week trading range of $3.44 to $9.45.

Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.