Vertex’s Non-Opioid Pain Candidate Hits Marks In Diabetic Peripheral Neuropathy

VX-548, which is set to read out Phase III data in acute pain in early 2024, demonstrated initial efficacy in chronic pain, but analysts say the drug will have to compete mainly on safety and tolerability.

Peripheral neuropathy
Vertex now has Phase II data for VX-528 in chronic pain while getting ready to file in acute pain • Source: Shutterstock

Vertex Pharmaceuticals Incorporated took another important step in its efforts to develop a NaV1.8 inhibitor for chronic pain on 13 December, reporting that VX-548 demonstrated statistical significance at three doses in diabetic peripheral neuropathy (DPN) versus a reference arm of Pfizer Inc.’s Lyrica (pregabalin). Analysts noted that while the drug hit the efficacy bar in DPN with data numerically similar to Lyrica, its best hope to compete in the generic-dominated pain market may lie in showing a better safety and tolerability profile.

Key Takeaways
  • Vertex’s VX-548 demonstrated efficacy for chronic pain reduction in a Phase II study in diabetic peripheral neuropathy.

  • The drug is a key component of Vertex’s efforts to develop non-opioid pain therapies for both acute and chronic pain indications

In a 192-patient, Phase II dose-ranging study, 23mg, 46mg and 69mg daily doses of VX-548 met statistical significance and showed what Vertex called clinically meaningful benefit in reducing pain 12 weeks from baseline as measured by the Numeric Pain Rating Scale

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