CURE Pharmaceutical Announces the Initiation of Clinical Trials for Erectile Dysfunction Product CUREfilm Blue
CURE Pharmaceutical Holding Corp. (“CURE” or the “Company”) (OTC: CURR), a technology focused, vertically integrated drug delivery and product development company in the pharmaceutical and health & wellness space, announced this week’s start of its initial Pharmacokinetics (PK)/bioequivalence studies in support of a previously approved Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). This application has been initiated via the 505(b)(2) drug approval pathway, and is in continuation of FDA-provided feedback in support of CURE’s clinical development plans for its CUREfilm Blue, an oral soluble film of sildenafil citrate (the active ingredient present in Viagra1) for the treatment of erectile dysfunction (ED).
CUREfilm Blue utilizes the Company’s patented and proprietary fast-dissolving drug delivery platform, known as CUREfilm, to deliver the active pharmaceutical ingredient (API) sildenafil citrate. By innovating beyond the traditional pharmaceutical delivery of pills and solutions, CURE is advancing this uniquely discrete, convenient and portable oral film product for achieving a better patient experience.
“We are so excited to advance our oral soluble film sildenafil citrate program to human clinical trials as we continue to focus our resources on a few key areas of differentiation – including applying our film technology to therapies for critical central nervous system (CNS) disease states as well as antiviral therapeutics,” said Vered Gigi, Chief Scientific Officer.
“This is an important milestone in our overall clinical program,” said Robert Davidson, CEO of CURE. “CUREfilm Blue is our first pharmaceutical product that utilizes our patented drug delivery platform to enter the human clinical phase. We believe delivering the main active ingredient sildenafil through this technology could improve the overall patient experience of those struggling with ED and become the new standard for treatment of the indication. We are using an expedited regulatory pathway through the FDA that we hope will enable us to bring this product to market faster than most other clinical program candidates.”