According to a new announcement, the FDA approved Suzetrigine (Vertex Pharmaceuticals), an oral selective NAV1.8 inhibitor, to treat patients with moderate to severe acute pain. Advertised as Journavx, novel, non -opioid therapy becomes the first new medical order to treat acute pain over 20 years.1
The new drug application (NDA) for Suzetrigine, typically known as VX-548, was based on data from a phase 3 program that included 2 randomized, double blind, placebo-controlled tests. 1 After Syndera Surgery and 1 after Bunionendomy surgery. The program also included a study of safety and efficacy of an individual arm that included patients with a wide range of surgical and non -surgical pain.2
Suzetrigine, which has previously received repetition of treatment, fast -track and priority review from the FDA, is contraindicated for simultaneous use with powerful CYP3A inhibitors. In addition, patients should avoid food or drink containing grapefruit when taking the drug.
“Today’s approval is an important milestone of public health in acute pain management,” Jacqueline Corrigan-Curay, JD, MD, Director of the FDA Evaluation and Research Center said in a statement.1 “A new non -opioid analgesic therapeutic order for acute pain offers the opportunity to mitigate certain risks associated with the use of opioids for pain and provides patients with another treatment option. To approve safe and effective alternatives for opioids for pain management . “
In the basic studies, Suzetrigine met the main end point of the time weighing a sum of the pain difference from 0 to 48 hours and showed a clinically significant decrease in pain from the initial value of 48 hours on the NPRS scale (NPRS) as well as Bunionectomy surgeries. Compared to placebo, the average difference in pain intensity from 0 to 48 hours for the comminoplasty was 48.4 and 29.3 for bunionectomy, showing a statistically significant improvement.3 Among patients in the safety and efficiency study of an arm, 83.2% named Suzetrigine as good, very good or excellent in the treatment of pain -based pain (PGA) scale (PGA).
All 3 studies revealed that Suzetrigine was safe and well tolerated by the participants, with the majority of adverse reactions (AES) referred to as mild to moderate. The findings of the 2 randomized controlled tests showed that after abdominal surgery, 50% of suzetrigine patients presented SA, compared to 56.3% in the placebo group. After bunionectomy, 31% of patients receiving treatment reported side effects, compared to 35.2% in the placebo group. Overall, the most common AEs observed in the study participants were itchy, muscle spasms, increased level of blood creatine phosphocinase blood and rash.
A poster presented in Anesthesiology 2024, the annual meeting of the American Society of Anesthesiologists, held on October 18-22 in Philadelphia, Pennsylvania, showed the positive effect of Suzetrigine across the Phase 3 Clinical Test. In these trials, 1118 participants underwent a commander and 1073 participants underwent bunionectomy. All participants were between 18 and 80 years old.4
Participants who rated 4 or higher in the NPRS after surgery were randomized in 2: 2: 1 to receive either Suzetrigine, Bitartrate/Acetaminophen (HB/APAP) or with placebo. The main end was the time -consuming sum of the pain difference (SPID48) calculated from NPRS scores over 48 hours. A higher SPID48 value showed a greater decrease in pain than the original value. The key secondary endpoints included Spid48 for Suzetrigine compared to HB/APAP and the time required for Suzetrigine to achieve a reduction of 2 points or higher NPR reduction compared to placebo. Security was also evaluated as a secondary endpoint.
The results showed that the treatment with Suzetrigine significantly reduced pain compared to placebo. In the trial of synoplasty, the average difference of minimum squares (LS) in Spid48 between Suzetrigine and the placebo was 48.4% (95% CI: 33.6, 63.1. P. <.001). In the Bunionendomy test, the average difference of LS was 29.3% (95% CI: 14.0, 44.6. P. = .0002).
None of the tests showed that Suzetrigine was superior to HB/APAP in terms of Spid48. However, Suzetrigine presented a faster appearance of significant placebo relief in both tests. Additional findings have shown that the average time to achieve a reduction in NPRS NPRS by NPRS was significantly smaller with Suzetrigine (119 minutes in the bunny test and 240 minutes in the Bunionectomy test) compared to the placebo ( 480 minutes in both tests. P. <.001 and P. = .0016, respectively).
Suzetrigine was generally safe and well tolerated in both tests, with AES according to post-surgical arrangements. The overall incidence of AEs was lower with Suzetrigine compared to placebo or HB/APAP. After synoplasty, the incidence of participants with any SA was 50.0% with suzetrigine, 56.3% with placebo and 60.7% with HB/APAP. After Bunionendomy, the percentages were 31.0%, 35.2%and 41.8%respectively. There were no serious side effects with Suzetrigine.
In another poster presented in Anesthesiology 2024, the researchers conducted a phase 3 study to evaluate Suzetrigine’s safety and effectiveness for medium to acute acute pain in a wider population of patients.5 This patient population included both postoperative surgical patients and non -surgical patients with painful medical conditions. The study was recorded adults aged 18 to 80 years with a pain rating of 4 or higher in NPRS after surgery or presented in a medical facility with recently developed moderate to severe acute pain over the last 48 hours. Participants received Suzetrigine for 14 days or until the pain was resolved.
The primary objective was to assess safety and the secondary aim was to investigate the efficacy of suzetrin in the treatment of acute pain at the end of treatment as estimated by a global patient’s evaluation. A total of 256 participants (222 surgery, 34 non -surgical) received Suzetrigine. The most common surgeries were orthopedic, plastic and otorolaryngology. The most common non -surgical conditions were sprains and strains of upper and lower extremities.
Overall, in this second she presented a poster, the souzetrin was generally safe and well tolerated both in surgical and non -surgical patients. Most AEs were reported as mild or moderately in serious, with the headache referring to the most common, which occurs in 7% of participants. No serious SAs were related to souzatrin, as noted by the researchers. The majority of participants (83.2%) evaluated the efficacy of souzetrin to treat pain as good, very good or excellent at the end of the treatment period.
In a previous study published in The Journal of Medicine of New EnglandThe researchers noticed that souzetrin had reduced acute pain over a period of 48 hours after bunionectomy with mild to moderate SA at the highest dose. This previous test was conducted as 2 phase 2, randomized, double blind, placebo -controlled studies. Participants included were between 18 years and 75 years of age with a score of at least 4 in the NPRS. Pain was also rated as moderate or severe on the scale of verbal categorical evaluation within 4 hours after completing surgery and general anesthesia for those who underwent cominoplasty and 9 hours after removing the Popliteal Scriatic Nerve Bloc on Postoperative Day Bunionectomy.6
For the test of the commander, 303 patients were included, with 81.5% who completed the treatment period. In the Bunionendomy test, 274 patients were included and 90.1% completed treatment. The average difference of the minimum squares for the high -dose group and the placebo group was 37.8 for the participants in the synopsis and 36.8 in the Bunionectomy test. For both studies, patients receiving the lower doses showed similar effects to placebo. Overall, the researchers said that headache and constipation were the most common unwanted events reported with Suzetrigine in this study.
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