FDA approves IND application for CBD product
Research-focused biotech company ANANDA Scientific was recently given the green light by the US Food and Drug Administration (FDA) for an Investigational New Drug (IND) designation for the clinical trial evaluating Nantheia ATL5.
Nantheia ATL5, an investigational drug using cannabidiol (CBD) in ANANDA’s proprietary delivery technology, was granted the approval for use in clinical trials as a CBD-based treatment for opioid use disorder.
Nantheia is a patented CBD delivery system designed to increase the CBD absorption. According to ANANDA, bioavailability was a major challenge.
“It is crucial for making CBD realize its profound therapeutic potential. The [bioavailability] problem has been distinctively resolved by ANANDA Scientific via its unique, patent-protected ‘Liquid Structure’ technology. It turns CBD (as well as other problematic plant-derived substances) into exceptional nutraceutical and pharmaceutical products that really work,” the company said.
The thin line between drugs and supplements
Currently, the only plant-derived FDA approved drug containing CBD is Epidiolex, produced by GW Pharmaceuticals. Epidiolex treats two rare forms of epilepsy in children over two years old, Lennox-Gastaut syndrome and Dravet syndrome.
So what does the announcement of another line of drug development for the dietary supplement industry? Attorney Jonathan Miller, general counsel to the US Hemp Roundtable, said not much.
“So it’s not relevant. We’ve already gone through this process of getting an IND for Epidiolex and the claim of the FDA was that the CBD was not introduced as a dietary supplement prior to the [Epidiolex] IND,” said Miller. “But it's clear now that CBD has been introduced as a dietary supplement and has been marketed as one, so the fact that there is another application for CBD as an IND is not a problem. The more we find good applications for CBD, the better it is for the industry.”
Looking ahead, Miller said he suspects congress will pass legislation that will require the FDA to regulate CBD as a supplement
Miller added that he is hopeful Dr. Robert Califf will be confirmed as the new FDA Commissioner, but says regardless he is going to congress to seek relief.
“What the FDA does is important, but they’ve been idling for more than 3 years now. They said they were going to take action in December 2018 and they’ve done nothing of substance. So maybe Dr. Califf will come in and push things forward, but we’re not taking anything for granted and that's why we’re focused on the legislation.”
Moving along quickly
While FDA drags its feet, ANANDA is putting the pedal to the metal.
“With the IND approved, we are now moving quickly to get the trial underway. We are excited to be working with the UCLA team and look forward to this trial advancing,” said Sohail Zaidi, ANANDA CEO. “This clinical study at UCLA is an important component of our clinical development efforts focused on opioid addiction, where non-addictive therapy is a significant unmet need.”
The study, which is funded by the National Institute on Drug Abuse (NIDA), will be led by principal investigators Edythe London, PhD, 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, PhD, Professor of Psychiatry and Biobehavioral Sciences at the Jane and Terry Semel Institute at David Geffen School of Medicine UCLA.
“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 London.
Summit to explore CBD
Several industry thought leaders will be speaking at the Sports & Active Nutrition Summit, which will focus on CBD, eSports, personalized nutrition and more. The summit returns in 2022 as an in-person event taking place February 14-16 in San Diego, with a leading session to focus on CBD in sports.