RE: The Link27 Aug 2025 17:14
Cheers MG
Also this.
with no FDA-approved medications currently available, despite the substantial public health burden they represent (source: U.S. Veterans Affairs Health Services R&D
The FDA have nothing approved, diddly squat.
Solvonis Therapeutics plc (LON: SVNS), ("Solvonis" or the "Company") an innovative biotechnology company co-developing therapeutics for mental health disorders, is pleased to announce that Awakn Life Sciences Corp. ("Awakn"), the company Solvonis plans to acquire, has reached a significant regulatory milestone. Awakn announced a positive outcome from a Pre-Investigational New Drug ("Pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") regarding AWKN-002, a proprietary oral thin film ("OTF") formulation of esketamine, designed for sublingual and buccal administration in combination with structured alcohol education. This drug candidate is being developed for the treatment of moderate to severe alcohol use disorder ("AUD") with a focus on U.S market.
The Pre-IND meeting, held on 16 December 2024, marks a critical step in the U.S. drug development process. During the meeting, Awakn received positive feedback from the FDA regarding its development strategy for AWKN-002. Notably, the FDA confirmed that no additional clinical data are required prior to initiating a Phase 2b trial for AWKN-002 in patients with moderate to severe AUD enabling Awakn to expedite its clinical development program. This decision provides a clear path forward for advancing the drug to the next phase of clinical testing.
Additionally, the FDA agreed that AWKN-002 can be reviewed under the 505(b)(2) New Drug Application (NDA) approval pathway. This pathway allows data from an approved esketamine product to support the development of AWKN-002 for AUD treatment, provided a scientific bridge is established between AWKN-002 and the reference product. This regulatory pathway is expected to streamline the process and potentially reduce time to market.
This outcome represents a major milestone for Awakn and, by extension, for Solvonis, highlighting AWKN-002's potential as a breakthrough treatment for AUD, a condition with significant unmet medical need. The positive feedback from the FDA reinforces the scientific and clinical promise of AWKN-002, enhancing its value as Solvonis continues with its proposed acquisition of Awakn, as announced on 16 December 2024.
FDA are obviously in need of cover in the field and so far they like what Solvonis have proposed.
Let's hope they can get it to the finish line
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