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, or APP-944, is composed of cis-clomiphene (zuclomiphene). Zuclomiphene is a potent nonsteroidal estrogen receptor agonist. Veru says that clomiphene, which contains 30-50 percent zuclomiphene, appears to be well-tolerated in studies conducted in men at doses as high as 400 mg/day and at up to three years of use. The company’s VERU-944 will be initially developed as a once weekly oral drug to treat hot flashes in men with advanced prostate cancer on ADT.
“As a 505(b)(2) drug candidate, VERU-944 may be developed on an accelerated basis and at lower cost and lower risk,” Mitchell S. Steiner, MD, chief executive officer of Veru Healthcare, said in a recent press release. “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.”