Vertex Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Journavx (suzetrigine) to treat adults with moderate-to-severe acute pain.
Journavx is a non-opioid oral treatment that targets NaV1.8 pain signals.
It is said to be the first and only FDA-approved non-opioid oral pain signal inhibitor. It also represents the first new class of pain medicine approved in over 20 years.
According to Vertex Pharmaceuticals, the painkiller is effective, well-tolerated, and has no addictive potential during use across all types of acute pain.
The biotechnology company has set the US wholesale acquisition cost at $15.5 per 50mg pill.
Vertex Pharmaceuticals CEO and president Reshma Kewalramani said: “With the approval of Journavx, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”
The FDA’s approval of Journavx was based on data from two late-stage trials, which demonstrated significant reductions in surgical pain compared to a placebo.
The safety profile of Journavx is primarily derived from data gathered in pooled, double-blind, placebo- and active-controlled trials involving 874 participants experiencing moderate to severe acute pain after abdominoplasty and bunionectomy. Additional safety data comes from a single-arm, open-label study with 256 participants suffering from moderate to severe acute pain across various conditions.
FDA Center for Drug Evaluation and Research acting director Jacqueline Corrigan-Curay said: “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.
“This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”
Despite its FDA approval, concerns about Journavx’s commercial potential remain, Reuters reported. Health insurers and hospitals may still prefer cheaper opioids.
Vertex Pharmaceuticals’ chief operating officer, Stuart Arbuckle, emphasised the company’s focus on overcoming insurance coverage and access challenges.
The company is also evaluating suzetrigine for peripheral neuropathic pain (PNP), with an ongoing Phase 3 programme for painful diabetic peripheral neuropathy.
Vertex Pharmaceuticals plans to advance its development programme for painful lumbosacral radiculopathy following regulatory discussions.
The biotechnology firm also has a clinical pipeline of investigational therapies targeting serious diseases. These include neuropathic pain, APOL1-mediated kidney disease, and IgA nephropathy, among others.
