Pharma Giant Johnson & Johnson Asks FDA To Approve Esketamine Nasal Spray For Treatment-Resistant Depression
Pharma Giant Johnson & Johnson Asks FDA To Approve Esketamine Nasal Spray For Treatment-Resistant Depression
Pharma giant Johnson & Johnson (NYSE:JNJ) announced Monday it had asked the Food and Drug Administration (FDA) to approve its nasal spray as a monotherapy for treatment-resistant depression (TRD) in adults.
製藥巨頭強生(紐交所:JNJ)週一宣佈,已要求美國食品和藥物管理局(FDA)批准其鼻噴霧劑作爲成人治療抵抗性抑鬱症(TRD)的單藥療法。
The New Jersey-based company's Spravato, contains esketamine as an active ingredient, which is a nasal spray derivative formulation of a dissociative anesthetic, ketamine. While for years, ketamine has been used as an anesthetic in medical settings, recent clinical trials led to its broader application, most commonly for depression treatment.
這家總部位於新澤西州的公司的Spravato,包含esketamine作爲活性成分,是氯胺酮的鼻腔噴霧衍生物製劑。多年來,氯胺酮一直被用作醫療環境中的麻醉劑,最近的臨床試驗導致其廣泛應用,最常用於抑鬱症治療。
FDA approved Spravato in 2019 but only in combination with oral antidepressants; it is available through a restricted program requiring monitoring by healthcare professionals. If the FDA approves the new drug application, this will be the first and only monotherapy for adults with treatment-resistant depression, writes Green Market Report's Adam Jackson.
FDA於2019年批准了Spravato,但只能與口服抗抑鬱藥聯合使用,通過由醫療保健專業人員監測的限制性計劃提供。如果FDA批准新藥申請,這將是第一個且唯一的成人抵抗性抑鬱症單藥療法,Green Market Report的Adam Jackson寫道。
Nearly 30% of the estimated 280 million people worldwide living with major depressive disorder have TRD, which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.
全球約2.8億抑鬱症患者中,近30%患有TRD,當同一抑鬱發作中接受兩種或兩種以上口服抗抑鬱藥物的反應不充分時就會出現TRD。
Read Also: Is Ketamine Efficacious For Depression And Other Mental Health Conditions? The Top 10 Studies Of 2023 Shed Some Light
閱讀更多:Ketamine對抑鬱症和其他心理健康狀況是否有效? 2023年前10項研究
More Than A Decade Of Research
十多年的研究
"Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don't effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones," stated Bill Martin, the head J&J's neuroscience team. "We're pleased to build on the more than a decade of research reinforcing the safety and efficacy of SPRAVATO and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option."
“許多患有難治性抑鬱症的患者花費了太長時間去嘗試多種未能有效緩解他們症狀的治療方法,這會導致患者和他們的親人承受重大的功能和情緒負擔,” 強生公司神經科學團隊領導比爾·馬丁(Bill Martin)說。 “我們很高興能夠秉承十多年來加強SPRAVATO安全性和有效性研究的成果,並期待與FDA合作,將這種創新療法作爲單一治療選擇帶給患者。”
The application is supported by positive results from a Phase 4 study that showed Spravato, when used alone, produced "a rapid change in Montgomery-Asberg Depression Rating Scale total score as early as 24 hours after the first Spravato dose and sustained through at least 4 weeks of treatment," J&J said.
該申請得到了第4階段研究的積極結果支持,結果表明當Spravato單獨使用時,J&J表示它能夠“在至少使用第一次Spravato劑量24小時後迅速改變Montgomery-Asberg抑鬱評分總分,並持續至少4周的治療。”
To date, Spravato has been approved in 77 countries and administered to more than 100,000 people worldwide.
到目前爲止,Spravato已在77個國家獲得批准,全球超過100,000人接受了該藥物治療。
Strong Sales
銷售強勁
J&J recently reported its financial results revealing nearly 100% growth in Spravato sales year-over-year. While the company suppressed analyst forecasts by reporting adjusted earnings per share of $2.80 versus the consensus of $2.62 and raised full-year earnings guidance, Spravato's sales numbers stood out, wrote Shadd Dales for Benzinga.
J&J最近發佈了其財務業績,顯示Spravato銷售額同比增長近100%。雖然該公司以調整後的每股收益爲2.80美元擊敗了分析師的預測,超過了共識的2.62美元,並提高了全年收益指引,但Spravato的銷售數字脫穎而出。
In the U.S. and worldwide, year-over-year Spravato revenues grew 93.2% and 98.5%, respectively. Overall, Spravato's growth was by far the strongest in Johnson & Johnson's Neuroscience portfolio, easily topping CONCERTA (Methylphenidate) growth on a worldwide basis (28.6%).
在美國和全球範圍內,Spravato的年銷售額分別增長了93.2%和98.5%。總體而言,Spravato的增長遠遠超過了強生神經科學產品組合中的CONCERTA(甲基苯丙胺)的全球增長(28.6%)。
Price Action
股價變動
J&J's shares traded 1.32 lower at $152.27 per share during Monday's mid-day session.
週一中午交易期間,強生的股票以1.32美元低於152.27美元的每股價格交易。
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- 首位患有TRD的患者在革新心理藥物治療研究中接受藥物治療。
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Photo: Michael Vi via Shutterstock
圖片:Michael Vi 通過 shutterstock