Pivot Pharmaceuticals (“a biopharmaceutical company engaged in the development and commercialization of premium cannabinoid-based nutraceuticals and pharmaceuticals”) announced they will file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) and Clinical Trial Application (CTA) with Health Canada to begin human clinical trials of the Companys pharmaceutical drug candidate for the treatment of Female Hypoactive Sexual Desire Disorder (HSDD). PVT-005 will use Pivot’s previously tested topical delivery system to deliver cannabinoids (1% CBD formulated) intravaginally.
Pivot points out there are many drugs available to treat the most common male sexual dysfunction (ED), but very little to treat the most common female sexual dysfunction – Hypoactive Sexual Desire Dysfunction.
Pivot’s Chief Medical Officer, Dr. Wolfgang Renz stated, “Given that our topical delivery system has previously shown to be safe and well tolerated when administered intravaginally in a clinical trial setting, we believe that we can deliver cannibinoids to target female sexual dysfunction, a large unmet medical need with a multi-billion dollar market. The use of a highly bioavailable and safe topical cannabinoid is a great option for treating this indication, avoiding the known side effects of existing therapeutics.”
They further point out that the Female Sexual Dysfunction market in the U.S. is estimated to exceed $4 billion with over 50 million potential sufferers.
So… is the goal helping women, a novel way to use Cannabis, or a slick product that might tap into the $4 billion dollar industry? Who are they seeking to serve here? Are women’s issues being served or exploited?
[By the way, as of this writing, Pivot’s stock is up 10% from what it was at the time of the press release.]