Pivot Pharmaceuticals (CSE: PVOT) (OTCQB: PVOTF) (FRA: NPAT) this morning announced that it 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 its pharmaceutical drug candidate for the treatment of Female Hypoactive Sexual Desire Disorder (“HSDD”), PVT-005. Pivot will employ its drug formulation and delivery platform technologies to develop a topical cream containing cannabinoids for perimenopausal, menopausal and post-menopausal women who have observed a decline in sexual desire and response. “In vitro results from our contract research laboratory indicated that PVT-005 (1% CBD – formulated) was highly bioavailable. Additional studies showed that the product did not cause any local irritation in an in-vivo model. We have also successfully conducted degradation and stability studies with the product candidate. As a result, we have selected a drug candidate for HSDD which we will move to IND and CTA filings with health authorities to conduct clinical trials in women. Our cGMP manufacturing partner, BioV Pharma Inc., will produce the clinical trial material made using our formulation technology,” Pivot Pharmaceuticals Executive Vice President, Product Development, Dr. Joseph Borovsky stated in the news release.
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About Pivot Pharmaceuticals Inc.
Pivot Pharmaceuticals Inc. is a biopharmaceutical company engaged in the development and commercialization of therapeutic pharmaceuticals and nutraceuticals using innovative drug delivery platform technologies. Pivot’s wholly-owned medical cannabis products division, Pivot Green Stream Health Solutions Inc. (“PGS”), conducts research, development and commercialization of cannabinoid-based nutraceuticals and pharmaceuticals. Pivot’s wholly-owned U.S. subsidiary, Pivot Naturals, LLC, based in Costa Mesa, California, will manufacture and supply finished powderized cannabis products such as food additives, capsules, bulk powder and stick packs to the California market. PGS has acquired worldwide rights to Ready-To-Infuse Cannabis (“RTIC”) oil-to-powder technology, BiPhasix™ Dermal Drug Delivery platform technology (topical), Solmic Solubilisation technology (oral) and Thrudermic Transdermal Nanotechnology (transdermal) for the delivery and commercialization of cannabinoid, cannabidiol (“CBD”), and tetrahydrocannabinol (“THC”)-based products. For more information, visit the company’s website at www.PivotPharma.com.
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