VX-993
- Generic Name
- VX-993
FDA Approves Journavx, a Novel Non-Opioid Painkiller, Offering New Hope for Acute Pain Management
• The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for treating moderate to severe acute pain in adults, offering a safer alternative to opioids.
• Journavx works by selectively blocking pain signals in the peripheral nervous system, reducing pain without the addictive potential and severe side effects associated with opioids.
• Clinical trials demonstrated Journavx's effectiveness in reducing pain after surgeries, with a safety profile comparable to placebo, though it didn't outperform opioid-acetaminophen combinations.
• Priced at $15.50 per pill, Journavx faces challenges in accessibility due to its higher cost compared to generic opioids, but it represents a significant step in combating the opioid crisis.
Vertex Pharmaceuticals Advances Pipeline with New Phase 3 Trials and Positive Data Readouts
• Vertex Pharmaceuticals increased its full-year product revenue guidance to $10.8 billion to $10.9 billion, driven by strong performance in CF and the early launch of CASGEVY.
• Three new programs advanced into Phase 3 clinical trials, including inaxaplin in APOL1-mediated kidney disease, suzetrigine in diabetic peripheral neuropathy, and povetacicept in IgA nephropathy.
• Positive Phase 2 data for povetacicept in IgA nephropathy demonstrated a mean 66% reduction from baseline in UPCR at 48 weeks, supporting the initiation of a Phase 3 study.
• The FDA review of suzetrigine in moderate to severe acute pain is underway, with a PDUFA date of January 30, 2025, and the company is preparing for a potential launch.
Vertex Initiates Rolling NDA Submission for Suzetrigine in Acute Pain Management
• Vertex Pharmaceuticals has begun a rolling NDA submission to the FDA for suzetrigine (VX-548) for moderate-to-severe acute pain, with completion expected in Q2 2024.
• Phase III trials demonstrated suzetrigine's efficacy in reducing pain intensity across various surgical and non-surgical pain conditions, supporting the NDA submission.
• Vertex is also advancing suzetrigine in neuropathic pain, with phase III trials planned for diabetic peripheral neuropathy (DPN) in the second half of 2024.
• Suzetrigine holds FDA Fast Track and Breakthrough Therapy designations for acute pain and DPN, highlighting its potential to address unmet needs in pain management.
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