Vertex takes next step for non-opioid pain med with FDA rolling review

2024-04-18

临床2期临床3期并购

Vertex Pharmaceuticals on Thursday announced updates across its suzetrigine (VX-548) pain programme, including the start of an FDA rolling submission seeking approval of the non-opioid drug in moderate-to-severe acute pain. The company says it is on track to complete the filing for the oral selective NaV1.8 pain signal inhibitor NaV1.8 pain signal inhibitor this quarter.

"Given the favourable benefit/risk profile demonstrated by suzetrigine across the entire clinical programme and the positive interactions with regulators, we are excited by the opportunity to rapidly advance suzetrigine…for the millions of patients suffering from acute and peripheral neuropathic pain," stated chief medical officer Carmen Bozic.

In a note to clients after the drug succeeded in two Phase III acute pain studies earlier this year, Stifel analysts said they "continue to view VX-548 as a blockbuster potential drug in chronic pain," where opioids are far less acceptable of an option due to potential abuse.

The two trials, conducted in patients who had undergone abdominoplasty or bunionectomy surgery, hit their primary endpoints against placebo, but didn't demonstrate superiority over Vicodin (hydrocodone/acetaminophen). Still, Stifel analysts suggested this drawback "may matter less for the long-term prospects" of suzetrigine given the tens of millions of prescriptions written each year for non-opioid analgesics to treat chronic pain.

That stance was echoed by key opinion leader Antje Barreveld, an associate professor at Tufts University School of Medicine and clinical researcher at Harvard Medical School, who told FirstWord in an interview that "when it comes to acute pain, any medication that has some applicability in the perioperative world is going to have high uptake. This will be especially so if it is an opioid alternative because we don't have a lot of those."

In addition to the acute pain programme, Vertex said it also plans to kick off a Phase III trial of suzetrigine in patients with diabetic peripheral neuropathy (DPN) next half. The move follows a positive Phase II readout in December where suzetrigine appeared to have similar efficacy to Viatris' Lyrica (pregabalin). The programme will consist of two 12-week trials evaluating once-daily suzetrigine against placebo, focusing on changes to weekly average of daily pain intensity scores from baseline as the main measure. A key secondary endpoint will compare the drug to Lyrica.

In addition, Vertex continues to enrol its Phase II study of suzetrigine in patients with lumbosacral radiculopathy, another form of neuropathic pain, and is on track to complete recruitment by year's end.

Vertex's advancements in pain come shortly after the company agreed to buy out Alpine Immune Sciences for $4.9 billion, its largest acquisition to date. The deal brings Alpine's asset for IgA nephropathy into Vertex's pipeline, bolstering the company's presence in the immunology space (see – Vital Signs: Dissecting dealmaking at Vertex and its Alpine takeout).

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构