Ophirex Secures FDA Agreement for Varespladib Snakebite Treatment Development

Ophirex, Inc. announced a regulatory agreement with the FDA to develop varespladib as an oral rescue treatment for snakebite envenomation under the FDA's Animal Rule. This pathway allows for human approval based on safety data from humans and efficacy data from animal studies.

Varespladib has received MUMS designation for treating snakebite in dogs. The drug has also been granted FDA Orphan Drug, Rare Pediatric Disease, and Fast Track designations. Phase 2 studies, BRAVO and BRAVIO, investigated varespladib in emergency patients; the primary endpoint in BRAVO was not met, but benefits were noted in a subgroup.

Ongoing studies will help determine the effective dose. The Defense Health Agency supports the development through the BSSA program, emphasizing a need for innovative solutions in snakebite treatment.