Esketamine oral thin film (OTF) for alcohol use disorder in the U.S.
The same approach as SVN-001, built for the U.S.: SVN-002 brings esketamine to moderate-to-severe AUD, with an FDA-agreed 505(b)(2) route and a scientific bridge to SPRAVATO®.
SVN-002 is investigational. Its efficacy and safety in AUD remain to be established in clinical studies. Patent grant, scope and Orange Book eligibility are not assured.
FDA agreed the 505(b)(2) route, and no additional clinical data are needed before Phase 2b
FDA feedback is not an approval or a guarantee of any outcome. SVN-002 is investigational. IND: Investigational New Drug application; 505(b)(2): an FDA pathway that can draw on data for an already-approved drug. Sources: Solvonis RNS, 21 January 2025, 22 July 2025, 22 June 2026 and 30 September 2026. SPRAVATO® is a trademark of Johnson & Johnson.
Esketamine OTF: peak levels in line with SPRAVATO®, and a strong psychedelic-type experience
ng/mL: 50 mg OTF vs SPRAVATO® 84 mg, reached in about 19 minutes
mystical-experience score (0–150): OTF vs placebo
serious adverse events; all 20 volunteers had dissociative effects
It is the standard measure of the psychedelic experience in psilocybin and LSD research. In a randomised trial of ketamine in at-risk drinkers, mystical-type experiences mediated the reduction in drinking (Rothberg et al., 2021).
SVN-002 is investigational. Peak levels are model estimates (OTF: Phase 1, 20 healthy volunteers; SPRAVATO® 84 mg: typical patient aged 18–60). Placebo-controlled study: 28 problem drinkers. Sources: Simons et al., Front Pain Res 2022; Perez-Ruixo et al., Clin Pharmacokinet 2021; Gent et al., J Psychopharmacol 2024; Rothberg et al., J Psychopharmacol 2021. SPRAVATO® is a trademark of Johnson & Johnson.
Granted patents to ~2041, and potential Orange Book listing
Covering the esketamine OTF formulation, granted in the U.S. and Europe; expected term to ~2041.
Esketamine OTF combined with psychotherapy in AUD and other substance use disorders, filed internationally.
Eligible patents can be listed in the FDA Orange Book, adding patent-based protection alongside regulatory exclusivity.
Patent grant, scope and Orange Book eligibility are not assured. SVN-002 is investigational. Sources: patents US 11,992,561 B2 and EP 3995137 B1, and PCT/US2025/013057; Solvonis RNS, 21 January 2025.
A U.S. population about four times that of treatment-resistant depression, and an established supervised-treatment model
Supervised in-clinic dosing visit with structured at-home digital psychosocial support, designed to align with established SPRAVATO® supervised-visit coding.
Epidemiological population estimates. SVN-002 is investigational. ¹ SAMHSA, 2024 NSDUH, Tables 5.2A and 5.2B (ages 12+; civilian, non-institutionalised); ² Zhdanava et al., J Clin Psychiatry 2021 (30.9% of 8.9m U.S. adults with medication-treated major depressive disorder); ³ Johnson & Johnson Q4 and full-year 2025 results (SPRAVATO® worldwide sales $1,696m in 2025 vs $1,077m in 2024). SPRAVATO® is a trademark of Johnson & Johnson.
One shared mechanism, two differentiated molecules, one for each market
Ketamine is manufactured and administered as a 50:50 mixture of two mirror-image enantiomers, R-ketamine (arketamine) and S-ketamine (esketamine). Both act primarily as NMDA-receptor antagonists.
S-ketamine binds the NMDA receptor with about 4–5 times greater affinity than R-ketamine (Ki 0.30 vs 1.4 µM, rat cortex)⁴. Esketamine is the active ingredient of SPRAVATO®.
SVN-002 leverages esketamine’s FDA precedent (SPRAVATO®) for a U.S. 505(b)(2) pathway, while SVN-001 develops racemic ketamine’s own UK and EU route.
SVN-001 and SVN-002 are not sequential. They are differentiated molecules, each built for its own market and regulatory pathway.
⁴ Zanos P, et al. “Ketamine and ketamine metabolite pharmacology: insights into therapeutic mechanisms.” Pharmacol Rev. 2018;70(3):621–660. doi:10.1124/pr.117.015198 (Ki values from Ebert et al., 1997). Bonaventura J, et al. “Pharmacological and behavioral divergence of ketamine enantiomers: implications for abuse liability.” Mol Psychiatry. 2021;26(11):6704–6722 (about 5-fold). Company information. SPRAVATO® is a trademark of Johnson & Johnson.