November/11/2019
Connecticut Pharmaceutical Solutions (CTPharma) has announced that the FDA has approved medical marijuana clinical studies to study stress and pain management using human subjects.
The announcement was made during a press conference held at the Beaumont Room at Yale School of Medicine. Among those present during the announcement of the launch of the clinical studies involving the Investigational New Drug (IND) were CTPharma founder Tom Schultz and Rino Ferrarese, the Commissioner of the Department of Consumer Protection in Connecticut, Michelle Seagull, and Yale school administrators as well as the medical researchers.
According to CTPharma, the initial stage of the clinical study will focus on safety and proper dosage when treating the symptoms. The study will select subjects randomly, who will be issued with placebo while adhering to the FDA protocols. While speaking to Cannabis Business Times (CBT), Ferrarese said that for the past century, America has been setting the pace in the pharmaceutical industry across the globe. He also noted that in the pharmaceutical market, CTPharma, an American company, has the only FDA-approved medical product, which is plant-based. The Connecticut Pharmaceutical Solution has the capability and discipline to apply marijuana plant extract formulations to prove their efficacy and safety to any standard.
CTPharma and Yale have been working since 2017 on the application process for the IND study.
FDA regulations require the researchers to submit applications before conducting any human test with a drug that is not approved by the FDA. For Investigation New Drug, the FDA requires the application to include:
- Protocols describing the proposed clinical studies
- Qualifications of the researchers involved in the studies
- Informed consent of the human subjects
- Protection of the rights, safety, and welfare of the human subjects
The FDA further reviews the IND to ensure that the clinical trials do not inflict harm to the human participants. The Agency also evaluates and verifies the informed consent form and protection procedures in place.
According to the Chairman of the CTPharma Board of Directors at the Yale School of Medicine, Michael Fedele, CTPharma, in partnership with Yale, are conducting the FDA-approved study providing the safety and efficacy of the Investigational New Drug. The IND is made of plant-based phytocannabinoids.
At the press conference, Dr Rajota Sinha said that she would be supervising part of the clinical trials. She further said that her work specializes in addiction, stress, trauma, and chronic illnesses. Dr Sinha said that at Yale, as they have been working at developing treatments for the symptoms and other disorders as well as understanding how the endocannabinoid system reacts to the medicine. Understanding the plant’s therapeutic potential requires the researchers to look at the positive and negative effects of plant-based marijuana drugs to develop treatments and prevention programs for specific illnesses.
Patients who want to participate in the clinical trials must be registered with the medical marijuana program in Connecticut. The Pharmaceutical Company is hoping that the state will be placed on the cannabis biotech map after successful clinical trials.
According to Fedele, medical marijuana has attracted significant interest in biotech research, and he believes that Connecticut will be at the forefront because of the clinical studies. He further noted that a substantial share of the biotech industry would be in Connecticut, thus creating jobs and boosting the state’s economy.
