Top-line results: Nonhormonal drug reduces menopausal hot flash severity
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Two phase 3 trials assessing an investigational oral, nonhormonal compound for the treatment of moderate to severe hot flashes in menopausal women met their coprimary endpoints, according to top-line data from the SKYLIGHT studies.
The SKYLIGHT 1 and SKYLIGHT 2 trials showed statistically significant reductions from baseline to weeks 4 and 12 in the frequency and severity of moderate to severe vasomotor symptoms for women assigned once-daily fezolinetant (Astella Pharma) 30 mg and 45 mg compared with placebo, according to a press release form Astella Pharma.
Serious treatment-related adverse events occurred in less than 2% of trial participants, with headache as the most common adverse event.
“We are encouraged by these results for fezolinetant, which mark the first phase 3 data in a new category of selective neurokinin-3 (NK3)-targeted treatments for moderate to severe vasomotor symptoms,” Salim Mujais, MD, senior vice president and therapeutic area head for medical specialties at Astellas, said in the release. “Vasomotor symptoms can add a significant burden and impact quality of life for women. We are hopeful that with fezolinetant, we will be able to deliver a novel nonhormonal treatment option.”
As Healio previously reported, data from a phase 2b study demonstrated that menopausal women experiencing moderate to severe vasomotor symptoms reported fewer weekly hot flashes and reduced symptom severity across doses of fezolinetant compared with women assigned placebo. Those findings, which also showed women assigned fezolinetant experienced improvements in patient-reported outcomes, were presented at the 2019 North American Menopause Society annual meeting.
SKYLIGHT 1 and SKYLIGHT 2 are ongoing double-blind, placebo-controlled studies evaluating 30 mg and 45 mg fezolinetant administered once daily for the first 12 weeks, followed by 40-week active treatment extension periods.
Astellas said detailed results will be submitted for publication and for consideration at upcoming medical meetings.
Perspective
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Nanette Santoro, MD
This report indicates that the 12-week trial of fezolinetant reduced hot flashes among women receiving active drug compared with placebo. Adverse events appear overall low with no concerning safety signals. It will be important to see the 52-week results, which are more reflective of “real-life” use, since hot flashes are not a 12-week problem.
Overall, these studies look favorable for the eventual approval of this novel, first-in-class, nonhormonal treatment for hot flashes. Those of us who care for menopausal patients are really looking forward to having an effective alternative to hormones for women who cannot or do not wish to use hormone therapy to treat their menopausal symptoms.
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