On Jan. 25, Forbes reported that biotechnology pharmaceutical company Ananda Scientific Inc. anunció ese mismo mes la aprobación de la FDA para el ensayo clínico que evalúa Nantheia ATL5, un fármaco en investigación que usa CBD como tratamiento complementario para el trastorno por uso de opioides. The study will be conducted at the University of California, Los Angeles (UCLA).
The initial structure of the drug is a softgel capsule, for oral consumption and containing 100mg of CBD. According to the pharmaceutical company, this product could have the ability to reduce opioid use in clinical patients or opioid addicts.
“This is IND’s fourth approval for our Nantheia line of investigational drug products, and further reinforces our vision to develop CBD as a treatment for a number of key indications,” said Sohail R. Zaidi, Ananda’s executive director in a press release.
The FDA stipulates that the main objective during the early preclinical development of a new drug is to determine its safety when used in humans and whether its production would be justified at the commercial level.
According to the Centers for Disease Control and Prevention (CDC), nearly 841,000 people have died since 1999 from drug overdoses, and more than 70% of drug overdose deaths in 2019 involved an opioid.
“The opioid crisis remains a serious problem in the United States, and we will continue to crack down on companies trying to profit from the sale of products with unfounded treatment claims,” FDA Deputy Chief Commissioner Amy Abernethy said in a press release.
the doctor Dr. Yasmin Hurd, chair of Ward-Coleman Translational Neuroscience and director of the Addiction Institute at Mount Sinai, demonstrated in preclinical animal studies that CBD decreases heroin seeking during drug withdrawal.