Canada Rules EHP-101, Potential Cannabidiol Treatment, Not Controlled Substance

EHP-101, a cannabidiol-derived investigational therapy being developed by Emerald Health Pharmaceuticals (EHP) to treat multiple sclerosis (MS), is not a controlled substance in Canada, the company announced.

The active ingredient in EHP-101 is a derivative of cannabidiol, abbreviated CBD. This is one of the most well-known active compounds in the cannabis plant, the other being tetrahydrocannabinol (THC). Unlike THC, CBD is not psychoactive; that is, it does not induce a ‘high’ — but it does have other effects throughout the body.

In Canada, cannabis and other mind-altering substances (like cocaine, opium, morphine, oxycodone, and codeine) are regulated under the Controlled Drug and Substance Act (CDSA). The new regulatory decision states that EHP-101 is not subject to the CDSA.

This decision has numerous implications. But most relevantly, it means fewer regulatory hurdles will have to be cleared to develop, test, and potentially market EHP-101. Controlled substances are subject to strict manufacturing codes and limited importation, and their use in clinical trials requires administrative clearance beyond what is needed for trials of non-controlled substances.

A similar decision in the United States was made in 2019.

“The determination in Canada that EHP-101 is not a controlled substance adds to the same determination by the U.S. DEA [Drug Enforcement Administration] last year, providing us more flexibility in advancing our clinical program globally,” Jim DeMesa, MD, president and CEO of EHP, said in a press release.

“These determinations by Canada and the U.S. also highlight the important difference between our novel molecules compared to natural cannabinoids. We plan to continue seeking these determinations in various countries as we expand our clinical program throughout the world,” DeMesa added.

Preclinical studies in MS mouse models showed that EHP-101 can reduce inflammation and promote remyelination (the reconstruction of the protective myelin ‘sheath’ that covers nerves and is damaged in MS).

Data from a recently completed Phase 1 clinical trial (NCT03745001), which evaluated the safety and tolerability of EHP-101 in healthy volunteers, showed that the investigational therapy had a good safety profile, with only mild to moderate adverse events being reported.

Phase 2 trials to evaluate the efficacy of EHP-101 in people with MS and systemic sclerosis (a chronic, inflammatory, autoimmune disease) are being planned.