Photo Credit: iStock.com/Alexandr Muşuc

FDA approval of a novel non-opioid analgesic will hopefully address the needs of many patients with acute pain and improve clinical outcomes and QOL.

Pain is one of the most prevalent reasons patients seek the use of non-prescription analgesics or seek medical care from their primary healthcare professionals (HCPs). Left unmanaged, pain can impose significant health and economic burdens on affected patients and the healthcare system, including an adverse impact on quality of life (QOL); delayed recovery; sleep disturbances; increased risks for stress, depression, and anxiety; reduced mobility; lost productivity; and direct and indirect expenses.^1,2

In October 2024, Vertex Pharmaceuticals released a report titled “The State of Pain in America,” which explored the facets of pain, its impact on patient QOL and productivity, current pain treatment options, limitations, the risks associated with traditional opioids, challenges related to treating acute pain, and the need for alternative therapies.²  The new report indicates that annually, an estimated 80 million adults in the US receive treatment for acute pain, and more than 40 million patients with acute pain receive a prescription for an opioid to manage their pain.² In addition, about 10% of patients with acute pain initially treated with an opioid continued with prolonged opioid use.^2,3  The authors wrote, “Although opioids can be effective, they also carry a labeled risk of addiction. Roughly 85,000 US adults are expected to develop opioid use disorder (OUD) within a year of their prescribed treatment of acute pain.” ²

The pharmaceutical company conducted a double-blind, quantitative survey involving 1,001 adults treated for acute pain in the last year and 547 HCPs who treated patients with acute pain in the previous month.  In a press release, “To further recognize the complexities of treating acute pain, Vertex commissioned the American Academy of Orthopedic Surgeons (AAOS) to conduct a separate survey among its membership of orthopedic surgeons who are on the frontlines of pain management. The sample included 49 US surgeon members of AAOS who treated patients with moderate-to-severe acute pain in the past month.”²

The survey revealed that 89% of patients surveyed indicated that pain interferes with day-to-day activities, with 70% reporting limitations in walking or exercising, 65% experiencing complications in engaging in hobbies or leisure activities, 69% reporting sleep disruptions, and 65% reporting psychologic and/or emotional challenges because of unmanaged pain. With regard to pain management, 77% were interested in trying a different medication, 52% expressed interest in new medicines with fewer and 31% reported discontinuing medication before the pain was resolved, of which 58% continued to experience pain. In addition, 49% of patients were concerned about the risk for opioid addiction, and 67% of patients reported that they would prefer a non-opioid medication for acute pain.²

With regard to perspectives from HCPs, 77% of HCPs and 51% of AAOS orthopedic surgeons surveyed reported encountering challenges when treating patients with moderate to severe acute pain with current options.² Moreover, 78% of HCPs and 74% of orthopedic surgeons reported concerns about the risk for opioid addiction among their patients; and 71% of HCPs and 59% of AAOS orthopedic surgeons surveyed stated there is a need for additional non-opioid medication options to manage their patients’ acute pain.² An estimated 88% of HCPs reported that their patients prefer non-opioid options for pain management.²

Recent Novel Non-Opioid Analgesic Approval

On January 30, 2025, the FDA approved Journavx (suzetrigine), a first-in-class oral, non-opioid, highly selective sodium channel blocker indicated as a treatment for adults with moderate to severe acute pain.^3,4 Clinical data revealed that this agent is an effective, well-tolerated medicine without evidence of addictive potential indicated for use with all types of moderate to severe acute pain.^3,4

The effectiveness of suzetrigine was evaluated in two randomized, double-blind, placebo- and active-controlled clinical trials involving patients from acute surgical pain.⁴  One trial was conducted after abdominoplasty, and the other, after bunionectomy. Participants with inadequate pain relief were permitted to use ibuprofen as a “rescue” pain medication in addition to the randomized treatment. Both trials showed a statistically noteworthy decrease in pain with Journavx compared with placebo.⁴ The safety profile of suzetrigine is primarily derived from pooled data from double-blind, placebo- and active-controlled trials involving 874 participants with moderate to severe acute pain after abdominoplasty and bunionectomy. Additional safety data come from a single-arm, open-label study with 256 participants experiencing moderate to severe acute pain from various conditions.⁴

The drug is supplied as 50-mg tablets, and the recommended dosage for suzetrigine is an initial dose of 100 mg taken orally on an empty stomach, followed by 50 mg every 12 hours, starting 12 hours after the initial dose.^3,4 The treatment should be used for the shortest duration necessary, with a maximum of 14 days, and patients should avoid grapefruit products. This agent is contraindicated for use with strong CYP3A inhibitors. The most commonly reported ADRs include pruritus, muscle spasms, increased creatine phosphokinase, and rash.^3,4

Clinician Insights

An internist stated, “I think the approval of a novel class of analgesics is exciting news. I have encountered patients who do not want to take opioid analgesics because of fear of addictive properties, with some patients continuing to struggle with pain, which affects almost every aspect of their lives.  This recent approval provides prescribers with another therapeutic option for the many patients who suffer with acute pain. The clinical trial data seems promising, the reported ADR profile is mild, and I look forward to learning more.”

A pharmacist stated, “The recent approval of the first-in-class analgesic Journavx (suzetrigine) is a great advancement, marking the first-in-class analgesic approved in 2 decades. This availability provides another therapeutic option for managing and treating acute pain in adults. Since it is a non-opioid analgesic, its unique mechanism of action of targeting a pain signal pathway is promising, especially as the opioid crisis continues. It will hopefully be of clinical benefit to patients living with acute pain who have concerns or fears about the risk for addictions. It will be interesting to see how many prescribers will consider this novel agent as a treatment option. As the news about the approval grows, there will probably be a lot of interest in this novel agent.”

The Future of Care

Effective treatment and management of acute pain warrants a patient-centered and multifaceted approach, weighing risks associated with certain therapies and considering patient factors. The findings of the recent report highlight the concerns of both patients and prescribers and the need for alternative options for pain management. The approval of a first-in-class non-opioid analgesic adds to the treatment landscape of non-opioid analgesics. It has the potential to diminish the risk associated with traditional opioid analgesics that patients and HCPs have expressed.  Hopefully, this novel non-opioid analgesic will address the needs of many patients with acute pain and improve clinical outcomes and QOL.