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news.Vivus has said its new drug application for EvaMist has been accepted for review by the FDA as a new treatment for vasomotor symptoms associated with menopause.
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EvaMist is a transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women. Vivus reported positive results from its phase III trial of EvaMist earlier this year.
Results showed that EvaMist decreased the number of hot flashes by 78%, from 10.8 hot flashes per day at baseline to 2.3 hot flashes after treatment. This decrease was statistically significant compared to placebo. The reduction in frequency and severity of moderate to severe hot flashes was statistically significant over placebo for all three doses of EvaMist evaluated. Importantly, application site irritation was 1.5% and was typically mild in nature.
“We are already working with the agency and look forward to gaining regulatory approval of this important new treatment for women suffering with the symptoms of menopause,” stated Leland Wilson, president and CEO for Vivus.