University of Nebraska Medical Center and ANANDA Scientific announce FDA approval of the IND for a clinical trial exploring treatment for Post-Traumatic Stress Disorder (PTSD)
The trial is being led by principal investigator Mathew Rizzo, M.D., the Reynolds Professor and chair of the UNMC Division of Neurological Sciences and Chief Doctor for neurological providers at Nebraska Medication.
The research will consider the effectiveness of Nantheia™ ATL5, an investigational drug utilizing cannabidiol in ANANDA’s proprietary supply expertise. An investigational new drug (IND) utility for the trial has been accepted by the U.S. Meals and Drug Administration (FDA).
“That is our second scientific trial concentrating on PTSD. We’re excited that UNMC’s analysis staff has partnered with us to judge our promising drug for this very debilitating situation,” mentioned Sohail R. Zaidi, ANANDA’s Chief Government Officer. “It is a crucial step in our efforts to supply sufferers with PTSD with doubtlessly improved therapeutic choices.”
“Advancing evidence-based analysis into new therapeutics to supply a big PTSD affected person inhabitants with new modern therapy choices is a key goal for our analysis staff,” Dr. Rizzo mentioned. “We’re delighted to be collaborating with ANANDA Scientific on this trial.”
Dr. Rizzo is also the director of the Nationwide Institutes of Well being’s Nice Plains IDeA Scientific and Translational Analysis Community. He chairs the manager committee of the American Mind Coalition which advocates to advance analysis for neurological cures.
Dr. Rizzo’s analysis staff will embody Jennifer Merickel, Ph.D., Cognitive Neuroscientist and Assistant Professor within the UNMC Division of Neurological Sciences and Brigette Vaughan, an Superior Follow Registered Nurse, Clinician and Researcher within the UNMC Division of Psychiatry.
This section II double-blind, placebo managed, randomized scientific research is planning to enroll 240 members to supply rigorous scientific and real-world analysis of the efficacy and security of Nantheia™ ATL5.
ABOUT NANTHEIA™ ATL5
Nantheia™ ATL5 is an investigational drug that makes use of cannabidiol in ANANDA’s propriety Liquid Construction supply expertise. Pre-clinical and preliminary scientific research present that ANANDA’s Liquid Construction™ supply expertise (licensed from Lyotropic Supply Programs (LDS) Ltd in Jerusalem, Israel) enhances the effectiveness and stability of cannabidiol. Nantheia™ ATL5 is an oral product with 100mg cannabidiol per softgel capsule.
ABOUT College of Nebraska Medical Middle
As Nebraska’s solely public tutorial well being sciences heart, UNMC is dedicated to the schooling of a twenty first century well being care work power, to discovering cures and coverings for devastating ailments, to offering the perfect take care of sufferers, and to serving the state and its communities by way of award-winning outreach. UNMC has six schools and two institutes, serving greater than 4,200 college students in two dozen packages. Researchers at UNMC carry out cutting-edge analysis in neurological sciences, oncology, infectious illness, and different key areas.
ABOUT ANANDA SCIENTIFIC
ANANDA is a number one research-focused biopharmaceutical firm pioneering high-caliber scientific research evaluating therapeutic indications corresponding to PTSD, Radiculopathic Ache, Nervousness and Opioid Use Dysfunction (Mt. Sinai and UCLA). The corporate employs patented supply expertise to make cannabinoids and different plant derived compounds extremely bioavailable, water soluble, and shelf-life steady and focuses on producing efficient, premium high quality pharmaceutical merchandise. The corporate is increasing its analysis base by way of a number of sponsored analysis agreements with universities to diversify its scientific portfolio. According to its sturdy research-based information, the corporate has a rising pipeline of nutraceutical over-the-counter merchandise. ANANDA has efficiently launched these merchandise within the U.S., Australia, and the U.Ok., with enlargement into extra markets such because the EU, China, Africa, and different international locations in Asia.