The U.S. Drug Enforcement Administration (DEA) has cleared the use of the active ingredient in EHP-101, an investigational therapy for treating multiple sclerosis (MS) and systemic sclerosis (SSc), according to Emerald Health Pharmaceuticals, the therapy’s developer.
After a detailed review, the regulatory agency has determined that the active pharmaceutical ingredient in EHP-101 — a non-reactive, non-psychotropic compound called VCE-004.8, derived from synthetic cannabidiol — is not classified as a controlled substance under the Controlled Substances Act.
This new status means EHP-101 is not defined as substance that could be associated with a potential for abuse, such as hallucinogens, narcotics, depressants, and stimulants, the company said.
“This determination by the DEA that our lead product candidate, EHP-101, is not considered a controlled substance in the U.S. is of great benefit to us,” Jim DeMesa, MD, CEO of Emerald Health, said in a press release.
EHP-101 is an orally available therapy that is being explored as a potential treatment for systemic sclerosis. It was found to modulate inflammatory and fibrotic processes in earlier mouse models of the disease.
Results from previous studies in animals also have shown that treatment with EHP-101 can potentially promote the formation of new blood vessels and prevent vascular damage, which is common in systemic sclerosis patients.
The study is recruiting up to 104 healthy adults who will be randomly selected to receive single ascending doses or multiple ascending doses of EHP-101, or a placebo. Results from this initial study, scheduled for completion in May, are expected to support further Phase 2 trials in patients with systemic sclerosis.
“Not being a controlled substance eliminates the many costs and complexities associated with developing controlled substances,” DeMesa said. “It facilitates the manufacturing and import of the product to the U.S. and simplifies the conduct of our non-clinical and clinical studies, including the selection of U.S. clinical sites to conduct our planned Phase 2 studies for MS and SSc patients.”
Orphan drug status, which allows for a faster schedule of development and review for approval, is given to potential therapies that have demonstrated promise to treat rare diseases.