Solvonis Therapeutics PLC (LSE:SVNS) CEO Anthony Tennyson talked with Proactive's Stephen Gunnion about the company’s exciting developments regarding AWKN-002, a drug candidate targeting moderate to severe alcohol use disorder. Tennyson highlighted the significant unmet medical need in the US, where 29 million people suffer from alcohol use disorder and 75% relapse within a year after treatment.
In December, Awakn Life Sciences, which Solvonis plans to acquire, received positive feedback from the FDA during a pre-IND meeting. The FDA approved the company’s proposal to skip Phase 2a trials and proceed directly to Phase 2b. Furthermore, it supported Awakn’s expedited regulatory pathway through the 505(b)(2) process, allowing reference to J&J’s Spravato data.
Tennyson explained that AWKN-002 is a repurposed version of esketamine delivered through an oral thin film for sublingual administration. He added, “This clarity from the FDA reduces time and provides a clear direction for the R&D program.” The next step involves establishing a scientific bridge to SPRAVATO before seeking Phase 2b approval.
Watch the video for more updates, and don’t forget to like, subscribe to Proactive’s channel, and enable notifications for future videos!
#SolvonisTherapeutics #AWKN002 #AlcoholUseDisorder #FDAApproval #PharmaceuticalInnovation #SKetamine #AddictionTreatment #BiotechUpdates #MedicalResearch #ProactiveInvestors
