Solvonis Therapeutics has reported positive bridging pharmacokinetic data for its SVN-002 programme, a key step toward a Phase 2b trial for moderate to severe alcohol use disorder in the US. CEO Anthony Tennyson said preclinical studies showed that sublingual and buccal delivery of esketamine achieved comparable exposure levels to intranasal administration, establishing the scientific bridge required by the FDA. The company is repurposing Johnson & Johnson's approved esketamine treatment Spravato via the FDA's 505(b)(2) pathway, targeting a market of around 15 million American adults with alcohol use disorder. Tennyson noted the data could support a narrower toxicology package and a faster, capital-efficient development timeline, with next steps including FDA discussions ahead of an IND application.
Solvonis Therapeutics plcPositive bridging data for SVN-002 supports FDA path to Phase 2b trial for alcohol use disorder.
Johnson & Johnson