Apricus Biosciences, Inc., a biopharmaceutical company committed to developing innovative medicines in the field of rheumatology and urology, recently announced that the United States Patent and Trademark Office (USPTO) issued the company a patent titled “Methods and compositions for treating Raynaud’s disease” with claims directed to treat Raynaud’s phenomenon. The patent will expire no earlier than in 2032.
RayVa™ is the proprietary name for the drug candidate that Apricus has developed to address Raynaud’s phenomenon. The phenomenon, which is secondary to systemic sclerosis, is a circulatory disease that affects both feet and hands, and affects about 3 to 5 percent of the United States’ population, most of which are women. Currently there are no approved therapies for Raynaud’s phenomenon.
The FDA noted that Apricus’ RayVa may qualify for priority review since it represents a response to an unmet medical need, since there are no other options to treat the disease. After its submission, which is expected to occur in 2017, the FDA will assess if RayVa’s New Drug Application qualifies for priority review.
Apricus’ CEO, Richard Pascoe, commented in a press release: “We are excited about the issuance of this patent as it further increases the value for the RayVa product as a first-in-class treatment for Raynaud’s phenomenon, which we are pursuing initially as secondary to scleroderma. We look forward to establishing proof-of-concept for RayVa in the first half of this year with the goal of advancing the RayVa clinical development program in this difficult-to-treat patient population for which there is no adequate or approved therapies in the United States.”
RayVa combines alprostadil, a vasodilator, with Apricus’ permeation enhancer, which is used as a topical cream to apply on affected extremities. In Late December 2014, patient enrollment began for a 45-patient Phase 2a clinical trial for the product.
Apricus Biosciences, Inc. is biopharmaceutical company focused on advancing science in the urology and rheumatology fields. The company is now developing a strategy to fund Femprox® development to address female sexual disorder.