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Vistagen Receives FDA “Study May Proceed” Letter Under its Refisolone IND Application, Enabling Further Phase 2 Clinical Development for the Treatment of Vasomotor Symptoms (Hot Flashes) due to Menopause
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":" SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced receipt of a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) under its U.S. Investigational New Drug (IND) application for refisolone nasal spray, the Company’s non-hormonal, non-systemic product candidate in Phase 2 development for treatment of moderate to severe vasomotor symptoms (VMS) (also known as “hot flashes”) due to menopause. The FDA’s Study May Proceed letter enables the Company to pursue further Phase 2 clinical development of refisolone in the U.S. for a large unmet need in women’s health, building on successful exploratory Phase 2a clinical studies for the treatment of menopausal hot flashes and premenstrual dysphoric disorder conducted in Mexico.\n\n\n“This regulatory milestone marks another important step forward in our women’s health program for refisolone. Approximately 75% of all women in America experience hot flashes during their menopausal transition, yet there is a critical need for new treatment options,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “As demonstrated in exploratory Phase 2a clinical data, refisolone has the potential to advance women’s health and bring a fast-acting, non-hormonal treatment option for millions of women seeking relief from menopausal hot flashes.”\n\n\nIn an exploratory randomized (N=36), double-blind, placebo-controlled Phase 2a clinical study in VMS (hot flashes) due to menopause in menopausal women with eight (8) or more daily hot flashes, refisolone was administered intranasally at a 3.2 μg dose as needed up to five (5) times daily for four (4) weeks. Refisolone (n=18) demonstrated statistically significant improvements versus placebo (n=18) in both the frequency and severity of daily menopausal hot flashes, with hot flash frequency reduced by 80% in refisolone-treated patients compared to 36% in the placebo group. The reduction in the frequency of hot flashes was observed as early as one (1) week (p Mexico by Pherin Pharmaceuticals, now a wholly owned subsidiary of Vistagen.\n\n\nAbout Refisolone Nasal Spray\n\n\nRefisolone (PH80) nasal ...