regulatory
confidence high
sentiment positive
materiality 0.65
Endovia's CannEpil for canine bone cancer pain gets FDA 'minor use' status, opening conditional approval path
SPLASH BEVERAGE GROUP, INC.
- FDA's Center for Veterinary Medicine determined CannEpil, an investigational CBD/THC oral solution for pain from bone cancer in dogs, qualifies as a 'minor use' under the MUMS program.
- The determination makes CannEpil eligible for the conditional approval pathway, and FDA said the minor-use status will be maintained through approval of the New Animal Drug Application (NADA).
- Endovia and Lupvindol BioSciences are scheduled to meet FDA on November 19, 2026 for a Pre-Submission Conference on required studies, manufacturing and regulatory submissions.
- The companies are finalizing U.S.-based FDA-compliant manufacturing to support a potential 2027 veterinary commercial launch; CannEpil remains an unapproved investigational new animal drug.