MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) ("MyMD" or "the Company"), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, today announced that the U.S. Drug Enforcement Administration (DEA) has conducted a scientific review and determined that investigational cannabinoid Supera-CBD™ is not currently considered a controlled substance or listed chemical. The scientific review of the chemical structure of Supera-CBD was conducted in accordance with the Controlled Substances Act (CSA) and its governing regulations.
"Currently, all FDA-approved cannabinoid products are considered controlled substances, with the exception of Epidiolex, and although plant-derived cannabidiol (CBD) is unscheduled, its use by military and federal civilian employees currently is prohibited without a valid prescription. This decision by the DEA is tremendous news for Supera-CBD and we are very pleased that our product candidate will not require DEA scheduling during development," said Christopher Chapman, MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. "We look forward to studying Supera-CBD’s potential to improve upon the benefits of CBD while retaining its safety and tolerability without intoxicating effects."
"It is a tremendous benefit to be able to conduct drug development without the burden of dealing with a scheduled product," said Dr. Jack Henningfield, Vice President, Research, Health Policy, and Abuse Liability at Pinney Associates, Inc. "We look forward to continuing our support of MyMD Pharmaceuticals as Supera-CBD advances through development."
Supera-CBD™ is a synthetic, non-toxic cannabidiol (CBD) analog that is an 8000-times more potent CB2 agonist than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown in preclinical studies to have anti-inflammatory effects. Supera-CBD is a unique synthetic analog of CBD whose structure has been modified to be CB2-receptor selective. Studies to investigate Supera-CBD’s binding and affinity to CB1 and CB2 receptors show that the compound had very low affinity to CB1 and had a four-fold increase in binding to the CB2 receptor in comparison to CBD. Supera-CBD has completed genotoxicity studies and the company has initiated preclinical pain studies in partnership with Johns Hopkins Medicine.
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