Solvonis Therapeutics (LSE:SVNS), an LSE-listed late-stage biopharmaceutical company focused on central nervous system disorders, has reported positive pharmacokinetic bridging data for SVN-002, its oral thin-film esketamine candidate targeting moderate-to-severe Alcohol Use Disorder in the United States.
The preclinical study found that combined sublingual-buccal administration of SVN-002 produced rapid systemic esketamine exposure within the range observed for intranasal esketamine, the FDA-approved reference product sold as Spravato by Johnson & Johnson, which generated worldwide sales of approximately $1.7 billion in 2025 for depression indications.
The result is directly relevant to the company's planned 505(b)(2) regulatory pathway, under which Solvonis intends to establish a scientific bridge to Spravato to avoid duplicating a full de novo development package, relying instead on existing third-party preclinical data, in-licensed Phase 1 clinical data, and targeted bridging studies.
Systemic esketamine exposure had been flagged by the FDA as a key consideration at a Type B pre-IND meeting held in December 2024 by Awakn Life Sciences, the asset's prior owner, before Solvonis acquired the programme.
"The data support that objective and provide an important basis for the next stage of regulatory engagement," said Chief Executive Anthony Tennyson.
Solvonis will now seek FDA feedback on the remaining nonclinical toxicology work required before submitting an Investigational New Drug application to support a Phase 2b trial in moderate-to-severe AUD patients.
