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2025年1月22日，强生公司的Spravato（艾司氯胺酮，esketamine）CIII鼻用喷雾剂获批成为治疗重度抑郁症成年患者的单一疗法，这一消息在生物医药领域引起了广泛关注。这一批准不仅为强生公司在抑郁症治疗市场带来了新的机遇，也为那些对传统口服抗抑郁药物反应不佳的患者提供了新的治疗选择。 在Spravato获批单一疗法之前，抑郁症治疗领域遭遇了一系列挫折。就在本月早些时候，Neumora Therapeutics公司备受关注的navacaprant在重度抑郁症后期研究中失败，未能显著减轻患者抑郁发作的严重程度。2024年12月，Relmada公司在对其治疗重度抑郁症的药物REL-1017进行无效性审查后，被迫停止两项三期试验。最引人注目的是，百健（Biogen）和Sage公司的药物Zurzuvae未能获得治疗重度抑郁症的批准，尽管该药物在2023年8月已获批用于治疗产后抑郁症，但在更大的重度抑郁症市场，监管机构认为两家公司未能提供该药物“有效的充分证据”。 在这样的背景下，Spravato的获批显得尤为珍贵。美国食品药品监督管理局（FDA）的批准，使Spravato成为行业内首个获批用于治疗重度抑郁症成年患者的单一疗法。这一批准是基于一项四期研究的数据，该研究表明，与安慰剂相比，Spravato单一疗法在蒙哥马利-阿斯伯格抑郁评定量表（Montgomery-Asberg Depression Rating Scale）评分上有 “快速且显著的改善”。此外，接受Spravato治疗的患者中，22.5%在四周内达到缓解，而安慰剂组仅为7.6%。 安全性方面，研究中Spravato的不良事件与文献报道一致，未出现新的安全问题。不过，该鼻喷雾剂带有关于镇静、解离以及自杀念头和行为的黑框警告，并且存在滥用和误用的风险。 强生创新药神经科学全球治疗领域负责人比尔·马丁（Bill Martin）表示：长期以来，医疗保健人员为患者提供急需的症状改善的选择有限。” 他还补充说，Spravato获批单一疗法可以帮助患者 “最早在24小时内就能感受到抑郁症状的改善，28天内持续改善，而且无需每日口服抗抑郁药物。 Spravato的活性成分艾司氯胺酮（Esketamine）是N-甲基-D-天冬氨酸（NMDA）受体的非选择性、非竞争性拮抗剂，而NMDA受体是抑郁症治疗的一个已知靶点。自2019年首次获批以来，Spravato已成为强生公司的高增长品牌之一，2024年第三季度全球销售额同比增长约55%，达到2.84亿美元。强生公司预计在周三公布其第四季度和全年业绩。 Spravato获批单一疗法，为抑郁症治疗领域注入了新的活力。不过，鉴于其存在的潜在风险，在临床使用过程中，医生和患者都需要谨慎对待。未来，随着对抑郁症研究的不断深入，希望能有更多安全有效的治疗方法问世，为广大抑郁症患者带来更多希望。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

Johnson and Johnson’s business center in Switzerland iStock, yuelan Spravato’s monotherapy nod on Tuesday comes after a series of setbacks in the depression space. With an FDA nod on Tuesday , Johnson & Johnson ’s esketamine nasal spray Spravato became the industry’s first monotherapy approved for use in adults with treatment-resistant depression. The approval gives J&J a boost in a space that has been difficult to crack for biopharma, marked by a series of setbacks in the last year or so. Earlier this month, for instance, Neumora Therapeutics’ closely watched navacaprant failed a late-stage study in major depressive disorder (MDD), unable to significantly lessen the severity of depressive episodes in treated patients. In December 2024, Relmada was forced to stop two Phase III trials of its MDD hopeful REL-1017 after a futility review came out against its favor. Perhaps most notable was the failure of Biogen and Sage to secure an MDD approval for their pill Zurzuvae, which the FDA in August 2023 cleared for postpartum depression. However, in MDD—a much larger market—the regulator found that the partners did not provide “substantial evidence of effectiveness” for Zurzuvae. With Tuesday’s regulatory win, Spravato can now be used without an oral antidepressant in adult patients who had shown inadequate response to at least two oral therapies. The approval was backed by data from a Phase IV study, which showed that Spravato monotherapy elicited a “rapid and superior improvement” in scores on the Montgomery-Asberg Depression Rating Scale versus placebo, according to the pharma’s announcement. Additionally, 22.5% of Spravato-treated patients hit remission at four weeks, as opposed to 7.6% in placebo comparators. As for safety, Spravato’s adverse event pro the study was consistent with what has been reported in the literature, with no new signals of concern. The nasal spray comes with a boxed warning for sedation, dissociation and suicidal thoughts and behaviors. Spravato is also prone to abuse and misuse. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” Bill Martin, Global Therapeutic Area Head of Neuroscience at J&J Innovative Medicines, said in a statement. Spravato’s approval as a monotherapy, he added, could help patients “experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants.” Esketamine, the active ingredient in Spravato, is a non-selective, non-competitive antagonist of the NMDA receptor, a known target in depression. Since its initial approval in 2019, Spravato has become one of J&J’s high-growth brands, surging around 55% year-over-year in the third quarter of 2024 to bring in $284 million worldwide. J&J is expected to report its fourth-quarter and full-year results on Wednesday . Correction (Jan. 28): This story has been updated from its original version to state that the new approval for Spravato was in treatment-resistant depression, not major depressive disorder. BioSpace regrets the error.