A neuroactive nasal spray could reduce hot flashes during menopause, according to new data from VistaGen Therapeutics.
In a 36-patient Phase IIa trial, VistaGen’s nasal spray reduced the average number of daily menopausal hot flashes over four weeks. The nasal spray, called PH80, is designed for use on an as-needed basis up to four times a day, similar to how a rescue inhaler is typically used for asthma.
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“With positive proof-of-concept data demonstrating the efficacy, safety, and tolerability of intranasal administration of PH80, we look forward to exploring prospects for the Phase 2b clinical development of PH80, on our own or with collaborators,” VistaGen CEO Shawn Singh told Clinical Trials Arena.
The positive early trial comes amid a wider push for non-hormonal therapies to treat menopausal hot flashes. Hormonal therapies such as estrogen can help moderate vasomotor symptoms, but the approach is also associated with an increased risk of heart complications.
On 12 May, Astellas Pharma’s Veozah (fezolinetant) received approval from the US Food and Drug Administration (FDA) as a non-hormonal therapy for use against moderate to severe vasomotor symptoms caused by menopause. Meanwhile, antidepressants are also commonly used as a hormone therapy alternative.
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An estimated 20 million women in the US experience hot flashes during menopause, with nine million experiencing severe symptoms.
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By GlobalDataVistaGen’s nasal spray pipeline
In the Phase IIa study of PH80, 18 women receiving PH80 saw their average daily number of hot flashes drop from 7.7 at baseline to 1.5 after four weeks of treatment. Among the 18 women receiving the placebo, the average number of daily hot flashes lowered from 8.0 to 5.1 during the same period. The number of reported adverse events was similar between the placebo and treatment groups.
PH80 forms part of VistaGen’s wider platform of nasal sprays targeting mental health conditions and other central nervous system diseases.
The company’s lead candidate, the nasal spray fasedienol, is at the Phase III development stage for social anxiety disorder. VistaGen recently restructured its Phase III programme for fasedienol after missing the primary endpoint in a previous Phase III study.
