February 24, 2014
TherapeuticsMD issued results from two
phase I trials of TX 12-004-HR, a rapidly
acting vaginal preparation capsule v. Novo
Nordisk’s Vagifem (estradiol vaginal tablet)
for the treatment of Vulvar Vaginal Atrophy
(VVA). ESTR-1K-499 was an open label, single
dose crossover, relative bioavailability study
comparing 10μg of TX 12-004-HR to 10μg of
Vagifem. ESTR-1K-500 had same design, but
compared 25μg of TX 12-004-HR to 25μg
of Vagifem. Study results showed substantially
lower systemic estradiol exposure of
TX 12-004-HR when compared to Vagifem.
This PK data suggests that TX 12-004-HR may
provide therapeutic advantages over Vagifem.
Biological effects showed statistically significant
results of quantitative endpoints, namely
reduction of vaginal pH (p=0.0002) and reduction
of vaginal parabasal cells. These results
will be used to design a development plan and
a clinical program to be submitted to FDA for
treatment of VVA in postmenopausal women.
June 23, 2008
QuatRx reported positive top-line results from a phase III trial of Ophena for the treatment of vulvovaginal atrophy. This randomized, double-blind, placebo-controlled, parallel group study enrolled 826 post-menopausal women in the US. The subjects were randomized into a 12-week treatment period to receive Ophena administered orally, once-daily at 30 and 60 mg doses or placebo. The co-primary endpoints were the change from baseline to week 12 in the percentage of parabasal cells in the vaginal maturation index, the percentage of superficial cells in the vaginal maturation index, vaginal pH, and improvements in the most bothersome moderate to severe vulvovaginal atrophy symptom. The study met all four co-primary endpoints, with the Ophena 60 mg dose demonstrating statistically significant improvements over placebo. Following 12 weeks of treatment with Ophena 60 mg, there was an average 30% decrease in parabasal cells compared to an increase of 4% with placebo and an average 11% increase in superficial cells as compared to 2% with placebo. The decrease in pH to a more favorable one in this Ophena treatment arm was also statistically significant as compared to placebo (-1.01 ± 1.1 versus -0.10 ± 0.8). In addition, women who identified dryness or painful intercourse as their most bothersome symptom showed significant improvements in each of these symptoms when treated with 60 mg of Ophena. Based on the results QuatRx plans to commence a second phase III trial later in 2008.