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FDA Approves Suzetrigine, New Alternative to Opioids for Acute Pain
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The drug is a selective NaV1.8 pain signal inhibitor and is the first new class of medication to treat acute pain in over 20 years.
The FDA approved suzetrigine (Journavx, previously VX-548; Vertex Pharmaceuticals Incorporated) to treat moderate-to-severe acute pain. The drug is a selective NaV1.8 pain signal inhibitor and is the first new class of medication to treat acute pain in over 20 years.1
"Today's approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year," said Reshma Kewalramani, MD, CEO and president of Vertex, in a news release. "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."1
Suzetrigine is the first new class of medications for pain management in over 20 years | Image credit: Tada Images | stock.adobe.com
From data published in the New England Journal of Medicine, investigators found that at the highest dose, the drug reduced acute pain over a 48-hour period after abdominoplasty or bunionectomy. Investigators aimed to establish the efficacy and safety of the drug in treating acute pain after an abdominoplasty in study one (NCT05034952) and bunionectomy in study 2 (NCT04977336). The trials were phase 2, randomized, double-blind, placebo-controlled studies including patients aged 18 to 75 years with a pain score of at least 4 on the Numeric Pain Rating Scale. Furthermore, they had a moderate or severe score on the Verbal Categorical Rating Scale within 4 hours after completion of the surgery and general anesthesia for abdominoplasty and 9 hours after removal of popliteal sciatic nerve block on postoperative day 1 for bunionectomy.2-4
In the abdominoplasty trial, individuals were assigned treatment randomly in a 1:1:1:1 ratio of: oral suzetrigine at a loading dose of 100 mg, followed by 50 mg every 12 hours (high dose); oral suzetrigine at a loading dose of 60 mg, followed by 30 mg every 12 hours (middle dose); oral hydrocodone bitartrate-acetaminophen every 6 hours; or oral placebo every 6 hours. For the bunionectomy trial, individuals randomly received treatment in a 2:2:1:2:2 ratio with high dose every 12 hours, middle dose every 2 hours, low dose of 20 mg followed by 10 mg every 12 hours, oral hydrocodone bitartrate-acetaminophen every 6 hours, or placebo every 6 hours. For both trials, the primary efficacy end point was the time-weighted sum of the pain intensity difference (SPID) over a period of 48 hours for suzetrigine compared with the placebo. Secondary endpoints included time-weighted (SPID) between suzetrigine and the placebo over a 24-hour period and percentage of individuals with a pain reduction of 30%, 50%, or 70% from baseline at 48 hours after the first dose of their respective treatment.2
There were 303 individuals included in the abdominoplasty trial and 274 in the bunionectomy trial. In both trials, few patients discontinued the high-dose compared with hydrocodone bitartrate-acetaminophen and the placebo at 9.2%, 27.6%, and 24.7%, respectively, for the abdominoplasty trial, and 3.3%, 11.7%, and 13.6%, respectively, in the bunionectomy trial. Furthermore, the least-squares mean differences in the high-dose group and placebo were 37.8 in the abdominoplasty trial and 36.8 in the bunionectomy trial. Investigators added that the lower doses had similar results compared to the placebo for both trials.2
As for safety, the most common adverse events (AEs) that occurred in at least 10% of patients in either trial group were nausea, headache, constipation, dizziness, and vomiting for the abdominoplasty trial and nausea and headache in the bunionectomy trial. There were 3 individuals in the abdominoplasty trial that experienced serious AEs, with 1 in the placebo group, 1 in the hydrocodone bitartrate-acetaminophen group, and one in the middle dose group (pulmonary embolism) There were no serious AEs in the bunionectomy trial.2
"This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential," said Jessica Oswald, MD, MPH, associate physician in emergency medicine and pain medicine in San Diego and a member of the Vertex Acute Pain Steering Committee, in a news release. "I believe Journavx could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed."1
