The FDA has accepted a rolling submission for a New Drug Application (NDA) for suzetrigine for moderate-to-severe acute pain, with the first module submitted and completion expected within the current quarter.
For neuropathic pain, specifically pain associated with diabetic peripheral neuropathy (DPN), Vertex has also successfully completed an end-of-phase 2 meeting with the FDA. Following positive phase 2 results, the company is preparing to launch a phase 3 study in the latter half of 2024. Suzetrigine has also received the FDA’s Breakthrough Therapy designation for its application in DPN treatment.
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