Solvonis shows sublingual Spravato PK match, eyes Phase 2b alcohol use trial
JNJ•Solvonis Therapeutics reported that preclinical pharmacokinetic studies showed sublingual and buccal administration of esketamine achieved exposure levels comparable to intranasal Spravato. The company plans a 505(b)(2) pathway IND submission for a Phase 2b trial targeting roughly 15 million Americans with moderate to severe alcohol use disorder.
1. Positive PK Bridging Data
Solvonis’s preclinical studies demonstrated sublingual and buccal delivery of esketamine yields comparable systemic exposure of esketamine and its major metabolites to the approved intranasal Spravato formulation, establishing the FDA-required scientific bridge for a new indication.
2. 505(b)(2) Regulatory Strategy
The company is leveraging J&J’s Spravato clinical and safety data under a 505(b)(2) pathway to file an IND application, aiming to streamline toxicology requirements and reduce capital expenditures ahead of a planned Phase 2b alcohol use disorder trial.
3. Targeted Alcohol Use Disorder Market
Solvonis estimates that moderate to severe alcohol use disorder affects about 15 million American adults, a market size significantly larger than the current depression patient population for Spravato, highlighting potential for expanded revenue streams.
