remedy Pharmaceutical protecting Corp. ("remedy" or the "business") (OTC: CURR), a expertise focused, vertically integrated drug beginning and product development business in the pharmaceutical and fitness & wellbeing area, announced this week's beginning of its initial Pharmacokinetics (PK)/bioequivalence studies in aid of a up to now accepted Investigational New Drug (IND) software with the U.S. meals and Drug Administration (FDA). This application has been initiated by means of the 505(b)(2) drug approval pathway, and is in continuation of FDA-supplied remarks in help of cure's scientific construction plans for its CUREfilm Blue, an oral soluble film of sildenafil citrate (the energetic ingredient current in Viagra1) for the treatment of erectile dysfunction (ED).
CUREfilm Blue makes use of the company's patented and proprietary speedy-dissolving drug start platform, known as CUREfilm, to convey the active pharmaceutical ingredient (API) sildenafil citrate. through innovating past the common pharmaceutical delivery of pills and solutions, cure is advancing this uniquely discrete, easy and portable oral film product for attaining a higher patient adventure.
"we're so excited to improve our oral soluble film sildenafil citrate program to human clinical trials as we proceed to center of attention our resources on a few key areas of differentiation – including making use of our film technology to remedies for crucial relevant apprehensive system (CNS) disorder states as well as antiviral therapeutics," talked about Vered Gigi, Chief Scientific Officer.
"here is a vital milestone in our standard medical software," observed Robert Davidson, CEO of treatment. "CUREfilm Blue is our first pharmaceutical product that makes use of our patented drug birth platform to enter the human medical phase. We accept as true with supplying the leading energetic ingredient sildenafil via this expertise might enhance the universal affected person adventure of these struggling with ED and turn into the brand new average for remedy of the indication. we are using an expedited regulatory pathway through the FDA that we hope will allow us to convey this product to market faster than most different clinical software candidates."
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