Endovia Health Sciences says it plans to make its next Food and Drug Administration (FDA) submission for CannEpil in the coming week and request a meeting with the agency to discuss the cannabinoid drug’s regulatory and development pathway.

CannEpil is a pharmaceutical-grade oral formulation made with isolated cannabidiol (CBD) and tetrahydrocannabinol (THC). The drug was originally developed for drug-resistant epilepsy, and Endovia holds exclusive worldwide rights to develop and commercialize it for human and veterinary uses.

In an announcement issued Monday, Endovia said it intends to request a pre-submission conference with the FDA to discuss how CannEpil could advance through the agency’s regulated drug-development process.

“CannEpil is our first major asset within that strategy, and we expect to make our next FDA submission in the coming week and request a pre-submission conference with the FDA,” said Endovia CEO Brady Cobb.

The company has not announced that CannEpil has received FDA approval, and the planned meeting represents an early regulatory step rather than an authorization to market the drug in the United States.

Endovia acquired the exclusive global rights to CannEpil in July. Its license covers drug-resistant and refractory epilepsy, seizure disorders and related neurological conditions in humans. The company later expanded the agreement to cover veterinary uses.

The veterinary program has already reached a separate FDA milestone. On August 25, the agency’s Center for Veterinary Medicine established an Investigational New Animal Drug file for CannEpil, formally beginning the regulatory process for its development as an investigational veterinary pharmaceutical. Endovia is initially pursuing the drug for cancer-related pain in companion animals, beginning with dogs.

Endovia said Monday that it is also evaluating additional cannabinoid formulations and intellectual property for potential licensing, acquisition or collaboration.

The company tied its broader development strategy to the evolving federal marijuana policy environment, including federal support during recent Drug Enforcement Administration (DEA) proceedings for moving marijuana from Schedule I to Schedule III of the Controlled Substances Act. Endovia said its strategy, however, does not depend on federal legalization of adult-use marijuana.