VERU-944 Therapy for Hot Flashes in Men Receiving Prostate Cancer Hormone Treatment Heads to Trial

VERU-944 Therapy for Hot Flashes in Men Receiving Prostate Cancer Hormone Treatment Heads to Trial
Veru Healthcare is set to begin a Phase 2 clinical trial evaluating VERU-944 (APP-944) for the treatment of hot flashes in men receiving hormone therapy for prostate cancer. The announcement comes after a Pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration (FDA). “We had a very positive meeting with FDA during which we received clarification on a path forward for the clinical development of VERU-944,” Robert H. Getzenberg, PhD, executive vice president for clinical development at Veru Healthcare, said in a press release. “The FDA expressed enthusiasm for the development of this product, acknowledging the importance of treating the unmet medical need of hot flashes in the large number of men that are undergoing androgen deprivation therapy.” About 80 percent of men on androgen deprivation therapy, or ADT, with drugs such as Lupron, Eligard and Firmagon, tend to experience hot flashes. Hot flashes are characterized by the subjective sensation of a rise in temperature in the face and trunk and are accompanied by a widening of blood vessels in the skin known as cutaneous vasodilatation, predominantly in the face, throat, and extremities, usually followed by profuse sweating. Hot flashes related to prostate cancer hormone therapy tend to persist over time, with the same frequency and intensity throughout the treatment course. VERU-944,
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