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).
OXNARD, Calif., March 26, 2019 (GLOBE NEWSWIRE)
CURE Pharmaceutical (OTC: CURR), an innovative drug delivery and development company, today 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, CEO 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.
About CURE Pharmaceutical
CURE Pharmaceutical is a vertically integrated drug delivery and development company committed to improving drug efficacy, safety and the patient experience through its proprietary drug dosage forms and delivery systems. CURE has a full-service cGMP manufacturing facility and is a pioneering developer and manufacturer of a patented and proprietary delivery system (CUREfilm™), one of the most advanced oral thin film on the market today. CURE is developing an array of products in innovative delivery platforms and partners with biotech and pharmaceutical companies. CURE has positioned itself to advance numerous therapeutic categories, including the pharmaceutical cannabis sector with partnerships in the U.S., Canada and Israel. The company’s mission is to improve people’s lives by redefining how medicines are delivered and experienced.
For more information about CURE Pharmaceutical, please visit its website at www.curepharma.com.
Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. There are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the ability to successfully market our products, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties and the ability to obtain financing on favorable terms. The forward-looking statements in this press release reflect the Company’s judgment as of the date of this press release.
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