Veru Healthcare to Advance Proprietary Drug for the Treatment of Hot Flashes in Men Receiving Prostate Cancer Hormonal Therapy Following FDA Meeting
FEMALE HEALTH (FHCO)
US:NASDAQ Investor Relations:
verupharma.com/investors
Company Research
Source: GlobeNewswire
MIAMI, May 24, 2017 (GLOBE NEWSWIRE) -- Veru Healthcare (NASDAQ:FHCO), a pharmaceuticals company focused on developing pharmaceuticals for men’s and women’s health and oncology, today announced that following a Pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration (FDA), it plans to advance into Phase 2 clinical trial its proprietary drug candidate, VERU-944, for the treatment of hot flashes in men receiving hormone therapy for prostate cancer. “VERU-944 addresses a $600 million US market,” said Mitchell S. Steiner, M.D., Chief Executive Officer of Veru Healthcare. “As a 505(b)(2) drug candidate, VERU-944 may be developed on an accelerated basis and at lower cost and lower risk. Importantly, VERU-944 has the potential to be the first FDA approved medication for this indication. Our plan is to commence the Phase 2 trial as soon as possible, and if successful, we expect to begin our Phase 3 trial in the second half of 2018.” “We had a very p
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