ANANDA Scientific Inc., (a biotech pharma company) today announced approval by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for the clinical trial evaluating Nantheia™ ATL5, an investigational drug using cannabidiol (CBD) in ANANDA’s proprietary delivery technology as an Adjunctive Treatment for Opioid Use Disorder. The study will be done at the Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA.
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“This is the fourth IND approval for our investigational drug Nantheia™ product line,and it further re-enforces our vision of developing CBD as a therapeutic for a number of key indications. This clinical study at UCLA is an important component of our clinical development efforts focused on opioid addiction, where a non-addictive therapy is a significant unmet need,” said Sohail R. Zaidi, ANANDA’s Chief Executive Officer. “We are excited to be working with the UCLA team and look forward to this trial advancing.”
This trial is being led by principal investigators Edythe London, Ph.D., Distinguished Professor of Psychiatry and Biobehavioral Sciences as well as Molecular and Medicinal Pharmacology at the Jane and Terry Semel Institute at David Geffen School of Medicine UCLA, and Richard De La Garza II,Ph.D., Professor of Psychiatry and Biobehavioral Sciences at the Jane and Terry Semel Institute at David Geffen School of Medicine UCLA. Funding for this trial is from the National Institute on Drug Abuse (NIDA). (Clinical Trials.gov Identifier: NCT03787628)
“The approval of the IND for this important clinical trial is a key milestone for our ongoing research into therapeutic alternatives for opioid use disorder and reversal of the effects of the opioid epidemic,” said Dr. London.
“With the IND approved we are now moving quickly to get the trial under way,” said Dr. De La Garza.
ABOUT ANANDA SCIENTIFIC
ANANDA is a leading research-focused biotech company pioneering high-caliber clinical studies evaluating therapeutic indications such as PTSD, Radiculopathic Pain, Anxiety and Opioid Use Disorder. The company employs patented delivery technology (licensed from Lyotropic Delivery Systems (LDS) Ltd. Jerusalem, Israel) to make cannabinoids and other plant derived compounds highly bioavailable, water soluble, and shelf-life stable and focuses on producing effective, premium quality pharmaceutical products. Consistent with its strong research-based data, the company also has a growing pipeline of nutraceutical over-the-counter products. The company has successfully launched these products in the US, Australia, and the UK, with expansion into additional markets such as the EU, China, Africa, and other countries in Asia. The company is expanding its research base through multiple sponsored research agreements with universities to diversify its technology portfolio.