CURE Pharmaceutical Augments Its Existing U.S. DEA
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Posted On: 03/23/2021 10:26:17 AM
CURE Pharmaceutical Augments Its Existing U.S. DEA License in Order to Initiate Development of Its Psychedelics-Based Pharmaceutical Clinical Pipeline
CURE Pharmaceutical Holding Corp. (“CURE” or the “Company”) (OTC: CURR), a vertically integrated drug delivery and product development company, announced today that it has secured an extension to its Schedule I U.S. Drug Enforcement Agency (DEA) license that will allow the Company to conduct research on psychedelics-based pharmaceuticals using compounds such as LSD, MDMA, and psilocybin as potential treatments for various mental health disorders. The license enables CURE to conduct fully integrated research at its facility utilizing leading compounds and its patented delivery platform, seeking innovative solutions in high-impact and unmet patient need areas.
Schedule I licenses are granted to companies with the qualifications and research protocols for the handling of drug substances with no accepted medical use and a high potential for abuse. Obtaining this type of license is a rigorous process, requiring a well-documented scientific investigation in a formal application, inspection of laboratory facilities and confirmation of facility security.
“This license will allow us to build out our previously announced psychedelics program safely and legally, expanding our specialty pharmaceutical pipeline and opening new doors to research advancement,” said Rob Davidson, CEO of CURE. “Since the company was founded, we have been focused on providing unique patient solutions and we’re excited to continue to do so using this expanded license in conjunction with our cGMP-certified and FDA-registered facility.”
CURE’s existing DEA license allows the company to manufacture cannabinoid-based pharmaceuticals. Last year, CURE used this license to complete a pharmacokinetic study of its preliminary 25mg cannabidiol (CBD) oral film showing improved bioavailability of CBD in healthy subjects when compared to 25mg soft gels. The study showed significantly higher serum concentration (Cmax) and significantly faster absorption (Tmax) comparing CURE's CBD oral film dosage form to a commercially available CBD soft gel.
Further research on psychedelic compounds as potential treatments for mental health disorders has gained significant interest in last few years. There is promising research being conducted at the private, academic, and federal level on treatment of depression, PTSD, addiction disorders, obsessive compulsive disorder, and anxiety.
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.
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 Statement
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 CURE’s judgment as of the date of this press release. CURE 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210323005442/en/
CURE Pharmaceutical Holding Corp. (“CURE” or the “Company”) (OTC: CURR), a vertically integrated drug delivery and product development company, announced today that it has secured an extension to its Schedule I U.S. Drug Enforcement Agency (DEA) license that will allow the Company to conduct research on psychedelics-based pharmaceuticals using compounds such as LSD, MDMA, and psilocybin as potential treatments for various mental health disorders. The license enables CURE to conduct fully integrated research at its facility utilizing leading compounds and its patented delivery platform, seeking innovative solutions in high-impact and unmet patient need areas.
Schedule I licenses are granted to companies with the qualifications and research protocols for the handling of drug substances with no accepted medical use and a high potential for abuse. Obtaining this type of license is a rigorous process, requiring a well-documented scientific investigation in a formal application, inspection of laboratory facilities and confirmation of facility security.
“This license will allow us to build out our previously announced psychedelics program safely and legally, expanding our specialty pharmaceutical pipeline and opening new doors to research advancement,” said Rob Davidson, CEO of CURE. “Since the company was founded, we have been focused on providing unique patient solutions and we’re excited to continue to do so using this expanded license in conjunction with our cGMP-certified and FDA-registered facility.”
CURE’s existing DEA license allows the company to manufacture cannabinoid-based pharmaceuticals. Last year, CURE used this license to complete a pharmacokinetic study of its preliminary 25mg cannabidiol (CBD) oral film showing improved bioavailability of CBD in healthy subjects when compared to 25mg soft gels. The study showed significantly higher serum concentration (Cmax) and significantly faster absorption (Tmax) comparing CURE's CBD oral film dosage form to a commercially available CBD soft gel.
Further research on psychedelic compounds as potential treatments for mental health disorders has gained significant interest in last few years. There is promising research being conducted at the private, academic, and federal level on treatment of depression, PTSD, addiction disorders, obsessive compulsive disorder, and anxiety.
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.
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 Statement
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 CURE’s judgment as of the date of this press release. CURE 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210323005442/en/
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