TherapeuticsMD stock plummets on receiving vaginal pain drug CRL

Shares in women’s healthcare specialist TherapeuticsMD (NYSE: TXMD) fell by 10.5% to $4.18 on Monday following news that the company had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) relating to its vaginal pain drug TX-004HR.

The US company, however, remains confident of receiving approval for TX-004HR, its investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

In the CRL, the FDA raised a concern over a lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal phase III Rejoice trial.