Vertex Painkiller Making Progress
- Posted by ISPE Boston
- On February 8, 2024
Vertex has announced positive results from its Phase 3 program in the treatment of moderate-to-severe acute pain using its selective NaV1.8 inhibitor called VX-548. NaV1.8 plays a critical role in pain signaling in the peripheral nervous system. Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of medicines that have the potential to provide effective pain relief without the limitations of opioids, including their addictive potential.
“We are very pleased with the results from the VX-548 pivotal program, which demonstrate a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings. The VX-548 benefit-risk profile ideally positions it to potentially fill the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex.
Vertex plans to submit a New Drug Application to the Food and Drug Administration (FDA) by mid-2024 with the goal of achieving a broad label in moderate-to-severe acute pain. VX-548 has secured Breakthrough Therapy and Fast Track designations in the U.S. for acute pain.
In addition, Vertex seeks to achieve a broad label in peripheral neuropathic pain. In support of this goal, the company recently reported positive Phase 2 results in painful diabetic peripheral neuropathy (DPN) and expects to advance to pivotal development in DPN with VX-548 following the end-of-phase 2 meeting with the FDA. Vertex has also initiated a Phase 2 peripheral neuropathic pain study of VX-548 in patients with pain caused by impairment or injury to nerve roots in the area of the lumbar spine.
In line with its portfolio strategy, Vertex continues to advance preclinical and clinical development of additional NaV1.8 and NaV1.7 inhibitors, for use alone or in combination, in acute and neuropathic pain. (Source: Vertex Website, 30 January, 2024)