Rapid Therapeutic Prepares to File Investigational New Drug Application for its CBD Metered Dose Inhaler with FDA
June 02, 2021 at 04:30 pm IST
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Rapid Therapeutic Science Laboratories, Inc. announced it has executed two contracts to conduct Phase 1 human clinical trials of its metered dose inhaler containing Cannabidiol. RTSL entered into these two contracts in preparation for filing an Investigational New Drug Application with the U.S. Food and Drug Administration. Filing is anticipated in the next 30 days. An IND is a request for the FDA's authorization to administer an investigational drug to humans and is the first step towards designing and conducting clinical trials in the U.S. RTSL engaged Dr. Charles Powell, MD who is the Chief Medical Officer (CMO) and founder of a primary care group in North Texas with over 90,000 patients from which volunteers will be solicited for the planned studies. Dr. Powell is responsible for oversight of the studies on behalf of RTSL. Dr. Powell in conjunction with Dr. Haresh Boghara, MD of Epic Medical Research, who has been engaged as RTSL’s primary medical investigator, will launch five clinical studies to assess RTSL’s MDI containing CBD for dosage, efficacy and safety. The planned studies will initially focus on therapeutic benefits of CBD relating to depression, anxiety, insomnia, ADHD and arthritis/chronic pain. Of importance, the studies will measure blood serum levels (pharmacokinetics) to support clinical observations. RTSL will need to file and obtain approval of the IND by the FDA to begin the planned studies. RTSL previously announced it was in discussions with Dr. Powell and Accent Clinical Research Professionals, LLC for eight clinical studies. These discussions fell through when the previously proposed lead investigator could not participate due to undisclosed personal reasons not having to do with the proposed testing. While the application process is pending with the FDA, RTSL plans to utilize its existing lab equipment to continue to develop and manufacture non-MDI aerosol products for sale to the growing hemp product market.
Rapid Therapeutic Science Laboratories, Inc. is a biopharmaceutical company. The Company is focused on developing potential commercial opportunities which involve the rapid application of therapeutics using inhaler technology. The Company has developed a method of formulating and manufacturing pressurized metered dose inhalers (pMDI) that contain and properly aerosolize proprietary formula of one or more patent pending pharmaceutical-grade cannabinoid compounds. It has developed and is continuing to develop a series of complementary products in addition to its inhaler. It is also focusing on manufacturing its own branded MDI under the nhaler brand name.