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OXNARD, Calif. — CURE Pharmaceutical Tuesday announced it has successfully completed a pre-IND (Investigational New Drug) review with the U.S. Food and Drug Administration (FDA). The FDA provided feedback supportive of CURE’s clinical development plans for its CUREfilm Blue, a soluble thin film for oral administration of sildenafil citrate (Viagra) to treat erectile dysfunction (ED). With this feedback, CURE anticipates submitting its IND application in preparation for multiple clinical trials starting in Q3 of 2019.
“Receiving the FDA’s guidance is a key step toward executing our clinical development program,” said Rob Davidson, chief executive officer of CURE Pharmaceutical. “We believe that CUREfilm Blue will help those who have trouble swallowing pills and will improve the experience of millions of patients suffering from ED.”
CURE is the developer and manufacturer of a patented and proprietary fast-dissolving delivery system, called CUREfilm, the most advanced oral thin film on the market today. This drug delivery technology has the potential to increase patient compliance because it quickly dissolves in the mouth and goes straight into the bloodstream without the need for water, chewing or swallowing. An oral soluble film is an ideal form for sildenafil citrate formulation because it is designed to improve solubility, reduce gastrointestinal effects, potentially decrease dosage and provide fast-acting treatment.
