TherapeuticsMD Inc (NYSEMKT:TXMD) reported its candidate TX-001HR met expectations in a study dubbed the Replenish Trial, which tested the candidate against a placebo for treatment of vasomotor symptoms in post-menopausal women.
Vasomotor symptoms include hot flashes, flushes and night sweats. TX-001HR was able to reduce the severity and number of these symptoms, with the result being statistically significant compared to the outcome of placebo treatment.
TherapeuticsMD’s TX-001HR is a combination of 17ß-estradiol and progesterone and it is in the form of oral softgel.
The Replenish Trial
TherapeuticsMD Inc (NYSEMKT:TXMD) enrolled 1,835 women patients aged between 40 and 45 years. TX-001HR was administered to these study subjects in four different doses. Some 416 patients received the 17ß-estradiol 1 mg/progesterone 100 mg dose. Another group of 423 patients received 17ß-estradiol 0.5 mg/progesterone 100 mg dose.
A group of 421 patients was given 17ß-estradiol 0.5 mg/progesterone 50 mg dose and another group of 424 patients received 17ß-estradiol 0.25 mg/progesterone 50 mg dose. The placebo group was 151 patients.
On the efficacy side, the primary endpoints TherapeuticsMD was pursuing were baseline change in severity and number of hot flashes after 4 weeks and after 12 weeks as compared to placebo.
On the safety side, the primary endpoint was the endometrial hyperplasia incidence following 12 months of treatment.
TX-001HR met the efficacy and safety targets, boosting TherapeuticsMD’s confidence in the marketing prospects of the drug as the FDA examines the drug’s data.
“We are very pleased that multiple doses of TX-001HR studied in the Replenish Trial demonstrated these positive results, suggesting that, if approved, this drug product candidate is poised to address the significant demand for bio-identical hormone therapy,” said TherapeuticsMD CEO Robert G. Finizio.
TherapeuticsMD Inc (NYSEMKT:TXMD) posted EPS loss of $0.13 on revenue of $5.53 million in 3Q16. The results missed the consensus estimate that called for EPS loss of $0.10 on revenue of $5.76 million.
Investors pushed up TherapeuticsMD shares in the last session following the release of the upbeat Replenish Trial results. While the stock only rose 0.65% in regular trading hours, it shot up sharply by more than 20% in the afterhours trading to close at $7.45.
Note: This article is written by Adam Russell and originally published at Market Exclusive.