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AWKN-002

About AWKN-002

AWKN-002 is a novel combination therapy consisting of a patent pending proprietary esketamine oral thin film (OTF) with manualised psycho-social support to treat moderate to severe AUD in the US.

Clinical Evidence:

• Ph1 was successful completed by LTS Lohmann and in-licensed by Awakn.

Clinical Development & Regulatory Pathway:

• In Phase 2b planning
• Positive Pre-Investigational New Drug Application (IND) meeting with FDA in December 2024, FDA supportive of 505(b)(2) pathway

Intellectual Property:

• Formulation patents internationally by LTS Lohmann Systems AG
• Method of Use patents filed internationally by Awakn
  

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