Shares in Solvonis Therapeutics PLC (LSE:SVNS, OTC:SLVNF), rose 12% to 0.21p after it said it had demonstrated that its experimental alcohol addiction medication releases the active ingredient into the bloodstream at levels comparable to an existing approved depression drug, clearing a significant regulatory hurdle.
The company is developing SVN-002, a dissolvable film containing esketamine, a fast-acting anaesthetic being tested as a treatment for severe alcohol addiction.
Rather than developing the drug from scratch, Solvonis is pursuing a faster regulatory route its (the FDA 505(b)(2) regulatory pathway) by showing its version works similarly to Spravato, an FDA-approved nasal spray form of esketamine already on the market for treatment-resistant depression.
In a laboratory study, Solvonis demonstrated that when SVN-002 dissolves under the tongue and inside the cheek, it delivers esketamine into the bloodstream at rates and levels that match Spravato.
This "bridging" evidence is critical because it allows regulators to rely on safety data from the already-approved drug rather than requiring duplicative testing.
The US Food and Drug Administration flagged this precise requirement last December when reviewing the company's development plan, making this data release a validation of the company's approach and a green light to proceed with the next phase.
Solvonis now plans to submit formal approval paperwork to start human trials, pending completion of additional animal toxicology studies. The company expects to launch a mid-stage clinical trial in patients with moderate-to-severe alcohol addiction within the next two years.
The market opportunity is substantial. Roughly 15 million American adults have moderate-to-severe alcohol use disorder, a condition where standard treatments often fail.
That is five times larger than the treatment-resistant depression population for which Spravato generated $1.7 billion in annual sales last year. Alcohol addiction currently lacks effective pharmaceutical options.
The tablet format is designed to be administered in a clinical setting with doctor supervision and educational support, rather than self-administered at home. This controlled approach mirrors how Spravato is used for depression patients.
The positive data de-risks Solvonis' regulatory strategy and brings the company closer to human testing in what remains an underserved medical market.
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