Journavx, a non -opioid drug drug, receives FDA approval

The Food and Drug Administration (FDA) approved the Journavx ™ (Suzetrigine) to treat measure to severe acid pain in adults.

The active ingredient in Journavx is Suzetrigine, a sodium channel inhibitor. Suzrigine inhibits the transmission of brain pain signals and spinal cord, selectively inhibiting Nav1 sodium channels.

Approval was based on data from two randomized, double blind, placebo -controlled tests that evaluated the efficacy and safety of souzetrin after abdominal surgery (clinicaltrials.gov ID: NCT05558410) and Bunionectomy surgery (clinicaltrials.gov ID: NCT055553366).

In order to be eligible for these tests, participants had to have moderate to severe pain in the verbal system of categorical evaluation and pain rating 4 or greater in the numeric scale of pain rating (NPRS), within 4 hours of completion of the Command of the 9-hour period after the interruption of regional anesthesia after bunionectomy.

The main endpoint for both studies was the time -consuming sum of the pain difference from 0 to 48 hours (SPID48) in the Suzetrigine team compared to the placebo group and then with the hydrocodone group of Bitartrate/Acetaminophen (HB/APAP ).

In the trial of synopsis, patients were randomly assigned to receive Suzetrigine (n = 447), placebo (n = 223) or HB/APAP (n = 448). Findings showed statistically significantly superior decrease in pain with Suzetrigine compared to placebo (minimal squares [LS] Average difference in Spid48, 48.4 [95% CI, 33.6–63.1]; P. <.0001). The average time until pain relief (defined as a reduction of ≥ 2 points in NPRS) was reported to be 119 minutes in the Suzetrigine group and 480 minutes in the placebo group.

In the Bunionectomy study, patients were randomly commissioned to receive suzetrigine (n = 426), placebo (n = 216) or HB/APAP (n = 431). The results showed that Suzetrigine showed a higher decrease in pain compared to placebo (the average LS difference in Spid48, 29.3 [95% CI, 14.0-44.6]; P. = .0002). The average time until pain relief reported that it was 240 minutes in the Suzetrykin team and 480 minutes in the placebo group.

Suzetrigine was not found superior to HB/APAP in Spid48 in any test (abdominal surgery: ls average difference in Spid48, 6.6 [95% -5.4, 18.7]; BunioneDomy: Ls May Spid48 Difference, -20.2 [95% CI, -32.7, -7.7]).

The most common side effects reported with suzetrigine were itching, muscle spasms, increased creatine phosphocinase and rash. The drug is contraindicated in patients receiving strong CYP3A inhibitors and should be avoided in those with severe hepatic damage (Child-Pugh Class C).

Journavx is provided as a 50mg tablet. The start dose is 100mg of oral, which must be taken on an empty stomach to avoid delay in appearing action. Starting 12 hours after the initial dose, the Journavx is administered to 50mg every 12 hours, with or without food. Grapefruit should be avoided. Dosage modifications are recommended for patients with hepatic impairment and those in simultaneously moderate CYP3A inhibitors.

The use of Journavx for moderate to severe pain has not been studied more than 14 days. Treatment for the shortest duration of time should be treated according to the individual goals of the patient.