CURE Pharmaceutical Holding, a technology focused, vertically integrated drug delivery and product development company in the pharmaceutical and health & wellness space, announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for its product CUREfilm Blue, an oral soluble film of sildenafil citrate (the active ingredient present in Viagra®1) for the treatment of erectile dysfunction (ED).
CURE is seeking approval of this product via the 505(b)(2) regulatory pathway to expedite the U.S. approval process.
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.
“Since CURE was founded, moving our flagship technology CUREfilm™ through the FDA regulatory process has been at the cornerstone of our pharmaceutical strategy. This approval of the IND filing from the FDA marks a significant milestone for our company, validating the value-proposition of our technology and proprietary dosage form,” said CURE CEO Rob Davidson. “Our oral film technology makes complete sense to meet patients’ sildenafil needs for treating ED. Our team has worked diligently for the past year to make several inroads on clinical efforts to achieve this important accomplishment and I am confident that we are optimally positioned to continue to trials in early 2021.”
“The erectile dysfunction market has evolved significantly over the last several years with the advent of telemedicine. Our patent pending CUREfilm Blue™ oral soluble film of sildenafil citrate should bring a significant value proposition to patients, physicians and providers in the erectile dysfunction market,” said CURE Chief Business Officer, Jonathan Berlent.
The global erectile dysfunction drug market is projected to reach approximately USD$6.6 Billion by 2025, at a CAGR of 6.0% over the five-year forecasted period with sildenafil representing a majority of the market according to a report by QYR Research.
CURE Pharmaceutical is the pioneering developer of CUREform, a patented drug delivery platform that offers a number of unique immediate- and controlled-release drug delivery vehicles designed to improve drug efficacy, safety, and patient experience for a wide range of active ingredients.
As a vertically integrated company, CURE’s 25,000 square foot, FDA-registered, NSF® and cGMP-certified manufacturing facility enables it to partner with pharmaceutical and wellness companies worldwide for private and white-labeled production. CURE has partnerships in the U.S., China, Mexico, Canada, Israel, and other markets in Europe.
Source: Company Press Release