Hepion Pharmaceuticals Receives Positive FDA Response on GV104 in Gambling Disorder, a Condition With No Approved Medication
Hepion's subsidiary Gravitas Life Sciences received positive FDA written responses to a Type B pre-IND meeting request for GV104, a buccal film of nalmefene, in gambling disorder — a condition with no approved pharmacotherapy. The FDA outlined a 505(b)(2) regulatory pathway, confirmed prior nonclinical and CMC data can be cross-referenced, and said the planned 12-week Phase 2 proof-of-concept design and primary endpoint are generally appropriate.
Key figures
- Drug Name
- GV104 (transmucosal buccal film of nalmefene)
- Phase Of Trial
- Phase 2 (planned)
- Study duration
- 12 weeks
- Regulatory pathway
- 505(b)(2) NDA relying in part on prior FDA findings for an approved nalmefene product
- Ind submission expected
- 2027
AI analysis
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