This Pharma Co. Kicks Off FDA Approval Process For CBD-Based Treatment Of Chronic Pain

Innocan Pharma Corporation INNO IP INNPF announced on Monday that it has submitted its letter of application for a Pre-IND meeting with the U.S. Food and Drug Administration (FDA), for its Liposome-Cannabidiol (LPT-CBD) injectable treatment of chronic pain.

With the move, the company initiated the regulatory process with the FDA for the approval of its prolonged CBD release technology for human use.

Why It Matters

"Innocan’s therapy has shown consistent efficacy in multiple pre-clinical trials in recent years of its LPT-CBD injectable treatment through prolonged and controlled release of CBD in animals with chronic pain conditions," the company said in a press release.

Iris Bincovich, CEO of Innocan, explained what the move means for Innocan.

"This is a key milestone for Innocan and marks our first step towards the FDA’s recognition of our technology," Bincovich said. "We see significant potential for our therapy, with an addressable market for pain management therapeutics expected to exceed US $100 billion by 2032, and we look forward to tapping that.”

Meanwhile, the innovative treatment is an alternative to opioid-based approaches to treating chronic pain.

In a recently published groundbreaking study, researchers weighed the pain-alleviating potential of medical marijuana versus opioids, showing that cannabis is similarly effective as opioids and traditional pain meds for the treatment of non-cancer pain.

See also: CBD A Potent Alternative For Dental Pain Management, Says Study

Moreover, many people are struggling with opioid use disorder (OUD). Fentanyl, an opioid used as a pain medication, is considered dangerous, addictive and one of the reasons why rates of drug overdose deaths are skyrocketing.

According to CDC data, overdose deaths caused by synthetic opioids other than methadone, including fentanyl and fentanyl analogs, increased by over 56% from 2019 to 2020.

What's Next

Innocan said at the Pre-IND meeting that it will focus on obtaining guidance from the FDA on the preclinical and clinical development plan thus enabling the initiation of an Investigational New Drug (IND) program in the country.

"We believe that Innocan’s unique treatment method, if and when it should become FDA-approved has the potential of being a highly valuable non-opioid addition in the medical arsenal of the management of chronic pain,” said Dr. Joseph Pergolizzi, Innocan’s FDA advisory board member.

Now read: CBD-Focused Pharma Co. Innocan Reveals 433% YoY Increase In 2023 Revenue As It Pursues FDA Approval