Vertex Narrows Focus for Pain Drug Journavx After FDA Feedback

Vertex Pharmaceuticals has encountered a setback in its efforts to expand the use of its non-opioid pain medication Journavx (suzetrigine) for chronic pain conditions. The company has decided to adjust its development strategy following discussions with the U.S. Food and Drug Administration (FDA).

FDA Limits Broad Label for Neuropathic Pain

Vertex CEO Reshma Kewalramani revealed that the FDA does not currently see a path to a broad indication for Journavx in peripheral neuropathy (PNP), a chronic pain condition resulting from nerve damage outside the brain and spinal cord. This development has prompted Vertex to revise its near-term plans for the drug's expansion.

"At this time, the FDA does not see a path to a broad indication," Kewalramani stated during an analyst call. As a result, Vertex is postponing its phase 3 trial of Journavx in lumbosacral radiculopathy (LSR) and will instead prioritize a second phase 3 study in diabetic peripheral neuropathy (DPN).

Focusing on Diabetic Peripheral Neuropathy

Vertex is now concentrating its efforts on securing approval for Journavx in DPN, which affects approximately 2.4 million people in the United States. The drug has already received breakthrough therapy designation from the FDA for this indication.

Kewalramani emphasized the company's revised strategy: "Our plan is now to go DPN first, then add on single indications, but work with the [FDA] to get to broad PNP." She added that while the FDA doesn't currently see a path to a broader PNP indication, "we have a clear agreement on DPN."

Pipeline Setbacks and Market Response

In addition to the Journavx news, Vertex disclosed another challenge in its pain portfolio. The company's sodium channel inhibitor VX-993, intended as a follow-up to Journavx, failed to outperform placebo in improving pain scores for patients who had undergone bunion removal surgery. Consequently, Vertex has halted the development of VX-993 as a monotherapy for acute pain.

These announcements, coupled with Vertex's second-quarter earnings report, led to a significant drop in the company's stock price. As of midmorning Tuesday, Vertex shares were trading down more than 15%.