$CURR News : Significantly higher serum concentrat
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Posted On: 07/27/2020 2:26:30 PM
$CURR News : Significantly higher serum concentration and absorption Showcases CUREform™ encapsulation and oral thin film technology
OXNARD, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- CURE Pharmaceutical (OTC: CURR), an innovative drug delivery and development company, today announced that its 25mg cannabidiol (CBD) oral thin film (OTF) showed improved bioavailability of cannabidiol in healthy subjects, compared with 25mg soft gels. Specifically, a pharmacokinetic (PK) study in 14 healthy adults showed a significantly higher serum concentration (Cmax) and significantly faster absorption (Tmax) from CURE's CBD OTF dose form than from a commercially available CBD soft gel. The study also suggests that the CUREform™ delivery platform, which entails solubilization and encapsulation of the molecule, might deliver better results than solubilization alone, as used in the soft gel product, and may play a synergistic or additive role in bioavailability.
CBD, a phytocannabinoid compound, has limited oral bioavailability because it is fat soluble, which is difficult for the body to absorb. It also degrades extensively via the first pass metabolism. CUREform™, CURE’s proprietary delivery platform, is uniquely designed to overcome such obstacles and deliver active ingredients more effectively.
“This study indicates that CUREform technology improved cannabinoid bioavailability, potentially allowing for a lower dose, which may facilitate a reduction in side effects and better compliance,” said Vered Gigi, PhD, Chief Scientific Officer of CURE Pharmaceutical. “We believe that our technology could be effectively applied to other molecules that have bioavailability challenges achieving multiple patient benefits.”
CURE’s CEO Rob Davidson, stated, “CURE’s delivery platform, which includes the encapsulation technology gained via the Chemistry Holdings acquisition, might have commercial applications for CBD, especially when given in high doses. Moreover, when we consider that CURE’s buccal, or transmucosal, application technology may avoid first pass drug metabolism, we might see further improvements beyond those observed in this study. The potential to meet a large consumer base and unmet medical need is compelling.”
About the Study
This open-label, randomized, single-dose, crossover study of 14 healthy adults compared the pharmacokinetics of a commercially available soft gel formulation (liquid encapsulated within a shell) of 25mg CBD to 25mg of CBD delivered via CUREfilm®, CURE’s oral thin film, or OTF, dose form. CUREfilm® OTF resulted in a significantly higher maximum serum concentration (~3x increase in Cmax) and a faster onset/absorption (~3x decrease in Tmax), compared to the reference product. No safety concerns were reported. In both arms of the study, the product was administered orally (PO) and, hence, ingested.
The study included a subjective survey comprising eight questions to aid in the understanding of CUREfilm® OTF as an acceptable dosage form. Results showed that none of the participants felt discomfort, pain, numbness or irritation during administration. 80% indicated “great” palatability, with 90% rating the CUREfilm® OTF experience as very pleasant or neutral.
About CURE Pharmaceutical Holding Corp.
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.
CURE’s delivery vehicles include CUREfilm®, an advanced oral thin film; CUREpods™, a novel chewable liquid or solid delivery form; and CUREdrops™, an emulsion technology that can be incorporated into different dosage forms (film, tincture, beverages, etc.), among others.
CURE’s clinical pipeline includes CUREfilm®Blue (sildenafil to treat erectile dysfunction), and CUREfilm®Canna (THC and CBD). Other OTC wellness products include Vitamin D, BCP Sleep, and Electrolytes. (Visit CURE’s catalog for the complete list.) As a vertically integrated company, CURE’s 25,000 square foot, FDA-registered, NSF® 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.
OXNARD, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- CURE Pharmaceutical (OTC: CURR), an innovative drug delivery and development company, today announced that its 25mg cannabidiol (CBD) oral thin film (OTF) showed improved bioavailability of cannabidiol in healthy subjects, compared with 25mg soft gels. Specifically, a pharmacokinetic (PK) study in 14 healthy adults showed a significantly higher serum concentration (Cmax) and significantly faster absorption (Tmax) from CURE's CBD OTF dose form than from a commercially available CBD soft gel. The study also suggests that the CUREform™ delivery platform, which entails solubilization and encapsulation of the molecule, might deliver better results than solubilization alone, as used in the soft gel product, and may play a synergistic or additive role in bioavailability.
CBD, a phytocannabinoid compound, has limited oral bioavailability because it is fat soluble, which is difficult for the body to absorb. It also degrades extensively via the first pass metabolism. CUREform™, CURE’s proprietary delivery platform, is uniquely designed to overcome such obstacles and deliver active ingredients more effectively.
“This study indicates that CUREform technology improved cannabinoid bioavailability, potentially allowing for a lower dose, which may facilitate a reduction in side effects and better compliance,” said Vered Gigi, PhD, Chief Scientific Officer of CURE Pharmaceutical. “We believe that our technology could be effectively applied to other molecules that have bioavailability challenges achieving multiple patient benefits.”
CURE’s CEO Rob Davidson, stated, “CURE’s delivery platform, which includes the encapsulation technology gained via the Chemistry Holdings acquisition, might have commercial applications for CBD, especially when given in high doses. Moreover, when we consider that CURE’s buccal, or transmucosal, application technology may avoid first pass drug metabolism, we might see further improvements beyond those observed in this study. The potential to meet a large consumer base and unmet medical need is compelling.”
About the Study
This open-label, randomized, single-dose, crossover study of 14 healthy adults compared the pharmacokinetics of a commercially available soft gel formulation (liquid encapsulated within a shell) of 25mg CBD to 25mg of CBD delivered via CUREfilm®, CURE’s oral thin film, or OTF, dose form. CUREfilm® OTF resulted in a significantly higher maximum serum concentration (~3x increase in Cmax) and a faster onset/absorption (~3x decrease in Tmax), compared to the reference product. No safety concerns were reported. In both arms of the study, the product was administered orally (PO) and, hence, ingested.
The study included a subjective survey comprising eight questions to aid in the understanding of CUREfilm® OTF as an acceptable dosage form. Results showed that none of the participants felt discomfort, pain, numbness or irritation during administration. 80% indicated “great” palatability, with 90% rating the CUREfilm® OTF experience as very pleasant or neutral.
About CURE Pharmaceutical Holding Corp.
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.
CURE’s delivery vehicles include CUREfilm®, an advanced oral thin film; CUREpods™, a novel chewable liquid or solid delivery form; and CUREdrops™, an emulsion technology that can be incorporated into different dosage forms (film, tincture, beverages, etc.), among others.
CURE’s clinical pipeline includes CUREfilm®Blue (sildenafil to treat erectile dysfunction), and CUREfilm®Canna (THC and CBD). Other OTC wellness products include Vitamin D, BCP Sleep, and Electrolytes. (Visit CURE’s catalog for the complete list.) As a vertically integrated company, CURE’s 25,000 square foot, FDA-registered, NSF® 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.
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