Vertex inches closer to acute pain market with FDA application acceptance

Vertex Pharmaceuticals has inched closer to bringing a new, non-opioid med to the blockbuster pain market, with the FDA accepting a rolling new drug application for the company’s NaV1.8 inhibitor VX-548 in moderate-to-severe acute pain.

Vertex is slated to complete the submission for VX-548, now dubbed suzetrigine, in the second quarter of this year, according to an April 18 company release.   

The Boston-based biopharma believes suzetrigine, which has snagged both FDA fast track and breakthrough therapy tags in the indication, could be the first new medicine class for acute and neuropathic pain in more than two decades. The opportunity is huge, with more than 80 million Americans prescribed medicine for acute pain each year, according to Vertex.

The rolling FDA submission follows a pair of phase 3 trial results shared this January. The late-stage trials found suzetrigine, which is aimed at the sodium channel, beat placebo in improving pain intensity. However, while the primary endpoints compared VX-548 to placebo, the oral drug failed to hit key secondary endpoints designed to show the non-opioid medicine is more effective than the existing, widely-used painkiller Vicodin, opening up the biotech to skepticism that suzetrigine is a better option than established, relatively cheap alternatives.

Vertex’s push to get suzetrigine over the finish line in acute pain is part of a broader program. The company also announced the planned launch of a phase 3 pivotal program testing suzetrigine among patients with painful diabetic peripheral neuropathy (DPN) in the second half of 2024, according to the April 18 release. The late-stage program is set to include two identical 12-week double-blind, placebo-controlled studies evaluating the efficacy and safety of 70 mg daily suzetrigine, with about 1,100 patients expected to enroll in each phase 3 study.  

In December 2023, Vertex shared phase 2 results assessing the NaV1.8 inhibitor among people with DPN, linking the pain candidate to statistically significant improvements in pain intensity. Suzetrigine has also landed breakthrough therapy status for treating pain associated with DPN.

The company is also studying suzetrigine in a phase 2 trial for patients with pain tied to lumbosacral radiculopathy, which is caused by inflammation or irritation of nerve roots in the lower back. Enrollment for the study is slated to wrap by the end of this year. 

The new Vertex updates crossed the wire at 8 a.m. ET, coinciding with a share price spike from $393 at market close yesterday to $408 directly after market open today. However, the stock has slipped down to $394 per share as of 10:45 a.m. ET today.