Vertex’s VX-548 For Acute Pain May Be Right On Time For Market

Medicare Policy Change In 2025 Favors Non-Opioids

 
• By Mandy Jackson
  
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The company’s NaV1.8 inhibitor succeeded in Phase III acute pain trials and will be submitted for US FDA approval in mid-2024. It may reach the market in time for Medicare reimbursement changes favoring non-opioids.

Abdominoplasty plastic operation to reduce the abdomen and remove cellulite
VX-548 succeeded in Phase III abdominoplasty and bunionectomy studies • Source: Shutterstock

The closely watched Phase III clinical trials for Vertex Pharmaceuticals Incorporated’s NaV1.8 inhibitor VX-548 in the treatment of moderate-to-severe acute pain following abdominoplasty, bunionectomy and other procedures or events successfully met most of the three studies’ endpoints. As a result, the company plans to submit the drug for US Food and Drug Administration approval by mid-2024 and, if approved, it could reach the market in time for Medicare reimbursement changes favoring non-opioids.

Key Takeaways

  • VX-548 achieved statistical significance versus placebo on the primary endpoint in two Phase III studies and was deemed safe and effective in a Phase III single-arm trial in acute pain.

Vertex closed up 2.4% at $446.08 – a new all-time high – on 30 January when it reported the Phase...

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