Acute Pain
Lauren Howell, PharmD
In January 2025, FDA approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for the treatment of moderate to severe acute pain. In an FDA press release announcing the approval, Jacqueline Corrigan-Curay, JD, MD, acting director of FDA’s Center for Drug Evaluation and Research, 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.”
Dosage and administration
Journavx works by selectively blocking a voltage-gated sodium channel that is expressed in peripheral sensory neurons, including dorsal root ganglion neurons, where it transmits pain signals. Inhibiting these channels also inhibits the transmission of pain signals to the spinal cord and brain.
Journavx is available as a 50 mg tablet. It should be swallowed whole, not chewed or crushed. Patients should avoid food or drink containing grapefruit juice during treatment.
The recommended starting dose is 100 mg orally. The starting dose should be taken on an empty stomach, at least 1 hour before or 2 hours after food. Clear liquids may be consumed during this time. Twelve hours after the starting dose, patients should begin taking 50 mg orally every 12 hours. These doses can be taken with or without food.
Journavx should only be used for the shortest duration of time that is consistent with individual patient treatment goals. The use of the medication for a period longer than 14 days has not been studied.
Adverse effects and safety
Concomitant use of Journavx with strong CYP3A inhibitors in contraindicated. If using Journavx concomitantly with moderate CYP3A inhibitors, reduce the Journavx dose. Additionally, avoid use with strong or moderate CYP3A inducers. Dosage modification of concomitantly used CYP3A substrates may be required when beginning or discontinuing treatment with Journavx.
Journavx use should be avoided in patients with severe hepatic impairment. Use in patients with moderate hepatic impairment may increase the risk of adverse reactions. The recommended dosage is lower in patients with moderate hepatic impairment than those with normal hepatic function.
Patients taking Journavx and using hormonal contraception containing progestins other than levonorgestrel and norethindrone should use an additional nonhormonal contraceptive method or an alternative hormonal contraceptive during concomitant use and for 28 days after discontinuing Journavx.
Clinical trials and efficacy
The efficacy of Journavx was established in two randomized, double-blind, placebo and active-controlled trials. One trial measured acute pain following full abdominoplasty while the other measured pain following bunionectomy. For both trials, pain was measured using a patient-reported 11-point numeric pain rating scale. Zero corresponded to no pain and 10 corresponded to the worst pain imaginable.
Patients were randomized to receive oral Journavx or hydrocodone bitartrate/acetaminophen for a duration of 48 hours. Patients receiving Journavx were given a loading dose of 100 mg, followed by 50 mg every 12 hours. Patients receiving hydrocodone bitartrate/acetaminophen received 5 mg/325 mg every 6 hours. For both groups, 400 mg of ibuprofen every 6 hours was available as a rescue medication, if needed for pain relief.
For the abdominoplasty group, treatment with Journavx demonstrated statistically significant superior reduction in pain compared to treatment with placebo. The median time to onset of perceptible pain relief for patients in the Journavx group was 34 minutes.
For the bunionectomy group, treatment with Journavx also demonstrated statistically significant superior reduction in pain compared with treatment with placebo. The median time to onset of perceptible pain relief for patients in the Journavx group was 60 minutes. ■