LAS VEGAS, NV--(Marketwired - June 19, 2017) - CV Sciences, Inc. (
CV Sciences President and CEO Michael J. Mona, Jr. commented, "Our pre-IND meeting with the FDA was very constructive and provided the Company with a favorable development roadmap for this important combination drug candidate. We have immediately commenced preparation of our Investigational New Drug application (IND) to initiate human trials. Our New Drug Application will be under the 505(b)2 pathway using nicotine-polacrilex gum, an FDA-approved nicotine replacement therapy, as our referenced listed drug. While nicotine-polacrilex gum is one of several approved nicotine replacement therapies for smoking tobacco addiction, all forms of nicotine replacement therapy have failed to achieve success in smokeless tobacco addiction. The FDA confirmed that it does not consider CBD to be a New Chemical Entity. We explained our scientific rationale for the addition of CBD to nicotine replacement therapies, based on our own proprietary research and peer-reviewed literature showing evidence of CBD inhibition of several different molecular pathways known to be important in treating nicotine addiction. We are extremely excited to advance this program in developing an effective therapy for one of the most addictive and potent ways of consuming nicotine, affecting 300 million users worldwide and 9 million users in the U.S."
About CV Sciences, Inc.
CV Sciences, Inc. (
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IRTH Communications
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