McCoun Jessica, Winkle Peter, Solanki Daneshvari, Urban Joshua, Bertoch Todd, Oswald Jessica, Swisher Matthew W, Taber Louise Anne, Healey Tiffany, Jazic Ina, Correll Darin J, Negulescu Paul A, Bozic Carmen, Weiner Scott G
Cenexel Georgia, Atlanta, GA, USA.
Anaheim Clinical Trials, Anaheim, CA, USA.
J Pain Res. 2025 Mar 25;18:1569-1576. doi: 10.2147/JPR.S509144. eCollection 2025.
Many patients experience inadequate pain control due to limited options that are both efficacious and safe for treating moderate-to-severe acute pain; therefore, opioids are still frequently prescribed for their effectiveness despite known tolerability issues and safety concerns. Suzetrigine, an oral, non-opioid, offers a promising alternative by selectively inhibiting the voltage-gated sodium channel 1.8 (Na1.8), a novel therapeutic target for pain management. Given the high selectivity of suzetrigine for Na1.8 (does not bind to other sodium channels/receptors with CNS activity), suzetrigine does not have CNS side effects or addictive potential associated with opioids. In the largest randomized, controlled phase 3 trials in established acute pain models, suzetrigine monotherapy demonstrated statistically significant and clinically meaningful reduction in moderate-to-severe acute pain compared to placebo.
To evaluate the safety and effectiveness of suzetrigine for the treatment of moderate-to-severe-acute surgical and non-surgical pain conditions, we conducted a phase 3, single-arm study in adults with moderate or severe acute pain on the verbal categorical rating scale and ≥4 on the numeric pain rating scale following surgical procedures or after presenting to a medical facility with moderate or severe acute pain of new origin. Participants received suzetrigine (100mg then 50mg every 12hrs) for 14 days or pain resolution, whichever came first. The primary endpoint was safety. The secondary endpoint was participant perception of suzetrigine's effectiveness in treating acute pain at the end of treatment using a patient global assessment.
Suzetrigine was generally safe and well-tolerated in participants (N=256) with a range of surgical and non-surgical acute pain conditions; the maximum severity for most participants who had adverse events was mild (71 participants; 27.7%) or moderate (21 participants; 8.2%). Most participants (213 participants; 83.2%) rated suzetrigine's effectiveness for treating pain on a patient global assessment as good, very good, or excellent.
Suzetrigine provides a safe and effective non-opioid, non-addictive treatment with broad applicability for moderate-to-severe acute pain.
NCT05661734.
由于治疗中度至重度急性疼痛的有效且安全的选择有限，许多患者的疼痛控制不足；因此，尽管存在已知的耐受性问题和安全隐患，但阿片类药物因其有效性仍经常被处方。舒泽曲秦是一种口服非阿片类药物，通过选择性抑制电压门控钠通道1.8（Na1.8）提供了一种有前景的替代方案，Na1.8是疼痛管理的一个新的治疗靶点。鉴于舒泽曲秦对Na1.8的高选择性（不与其他具有中枢神经系统活性的钠通道/受体结合），舒泽曲秦没有与阿片类药物相关的中枢神经系统副作用或成瘾潜力。在已建立的急性疼痛模型中进行的最大规模随机对照3期试验中，与安慰剂相比，舒泽曲秦单药治疗在中度至重度急性疼痛方面显示出统计学上显著且具有临床意义的降低。
为了评估舒泽曲秦治疗中度至重度急性手术和非手术疼痛状况的安全性和有效性，我们对在言语分类评定量表上为中度或重度急性疼痛且在数字疼痛评定量表上手术或因新出现的中度或重度急性疼痛就诊于医疗机构后≥4的成年人进行了一项3期单臂研究。参与者接受舒泽曲秦（100mg，然后每12小时50mg）治疗14天或疼痛缓解，以先出现者为准。主要终点是安全性。次要终点是参与者在治疗结束时使用患者整体评估对舒泽曲秦治疗急性疼痛有效性的感知。
舒泽曲秦在患有一系列手术和非手术急性疼痛状况的参与者（N = 256）中总体安全且耐受性良好；大多数发生不良事件的参与者的最大严重程度为轻度（71名参与者；27.7%）或中度（21名参与者；8.2%）。大多数参与者（213名参与者；83.2%）在患者整体评估中对舒泽曲秦治疗疼痛的有效性评为良好、非常好或优秀。
舒泽曲秦为中度至重度急性疼痛提供了一种安全有效的非阿片类、无成瘾性的治疗方法，具有广泛的适用性。
NCT05661734。
