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News: CURE Pharmaceutical CBD Oral Thin Film Pharmacokinetic Study Shows Improved Bioavailability Compared to CBD Soft Gel
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.
Forward-Looking Statements
Statements CURE makes in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. CURE intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and is making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, without limitation, the ability to successfully market the partnered products, the difficulty in predicting the timing or outcome of related research and development efforts, partnered 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. The Company disclaims any intent or obligation to update these forward-looking statements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of our securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Contact:
Media:
Deanne Eagle
deanne@planetcommunications.nyc
917.837.5866
Investors:
Ina McGuinness
investor@curepharma.com
805.427.1372
Or
Gary Zwetchkenbaum
Plum Tree Consulting LLC
516.455.7662
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.
Forward-Looking Statements
Statements CURE makes in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. CURE intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and is making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, without limitation, the ability to successfully market the partnered products, the difficulty in predicting the timing or outcome of related research and development efforts, partnered 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. The Company disclaims any intent or obligation to update these forward-looking statements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of our securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Contact:
Media:
Deanne Eagle
deanne@planetcommunications.nyc
917.837.5866
Investors:
Ina McGuinness
investor@curepharma.com
805.427.1372
Or
Gary Zwetchkenbaum
Plum Tree Consulting LLC
516.455.7662
