FORT LAUDERDALE, Fla., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Endovia Health Sciences, Inc. (NYSE American: EDVA) and Lupvindol BioSciences have announced that the U.S. Food and Drug Administration's (FDA) Center for Veterinary Medicine has determined that CannEpil®, an investigational oral solution containing cannabidiol (CBD) and tetrahydrocannabinol (THC), qualifies as a "minor use" under the Minor Use and Minor Species (MUMS) program for managing bone cancer pain in dogs. This classification allows CannEpil to pursue a conditional approval pathway.

Read More

The FDA's designation of minor use will be maintained throughout the approval process of the New Animal Drug Application (NADA). The MUMS program aims to enable quicker access to therapies for less common diseases in animals by allowing conditional approval based on safety and manufacturing criteria, while further effectiveness data can be gathered post-approval.

Endovia and Lupvindol are scheduled to meet with the FDA on November 19, 2026, for a Pre-Submission Conference to discuss CannEpil's development program, including essential studies and regulatory submissions. Concurrently, the companies are working on establishing U.S.-based manufacturing capabilities to support the clinical program and a potential launch in 2027, contingent on regulatory approvals.

Brady Cobb, Interim CEO of Endovia Health Sciences, highlighted the significance of this regulatory milestone for CannEpil: "This determination provides clarity regarding our pathway with the FDA. We are advancing our FDA development program while simultaneously preparing for commercialization."

Cobb emphasized CannEpil's potential as a regulated cannabinoid medicine to address the pain of dogs with cancer, while laying the foundation for broader development avenues.

The MUMS conditional approval pathway is designed to promote new animal drugs for uncommon conditions, allowing market access while further clinical data is collected for full approval. It is essential to note that CannEpil® remains investigational and has neither been approved nor conditionally approved by the FDA, and the proposed 2027 commercial launch depends on successful regulatory navigation and manufacturing readiness.

About CannEpil®

CannEpil® is a proprietary formulation intended for managing pain associated with canine bone cancer, part of Endovia's strategy to develop cannabinoid-based therapeutics under federal regulations, paving the way for both veterinary and human applications.

About Endovia Health Sciences

Endovia Health Sciences, Inc. focuses on creating a diversified platform for cannabinoid therapeutics across pharmaceutical development and regulatory frameworks.

About Lupvindol BioSciences

Lupvindol BioSciences specializes in cannabinoid-based drug development, led by Hunter Land, Ph.D., with experience in the development of Epidiolex® and Sativex®.

Forward-Looking Statements

This announcement contains forward-looking statements regarding CannEpil®'s development, manufacturing, and commercialization. Actual outcomes may differ due to various risks, including obtaining financing, regulatory approvals, and market conditions. Risks are outlined in the Company’s filings with the Securities and Exchange Commission.