BioXcel寻求FDA扩大精神分裂症治疗的标签适用范围-动脉网

BioXcel Seeks FDA Label Expansion For Schizophrenia Treatment

benzinga 等信源发布 2025-08-27 12:01

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BioXcel Therapeutics Inc.

BioXcel治疗公司

BTAI

announced that its SERENITY At-Home Phase 3 trial of BXCL501—its sublingual dexmedetomidine film for acute agitation in bipolar disorder or schizophrenia—

宣布其针对双相情感障碍或精神分裂症急性躁动的舌下右美托咪定薄膜BXCL501的Serenity家庭III期试验——

met its primary endpoint

达到了主要终点

。

The results show consistent symptom reduction across 2,400+ episodes. It will now support an FDA supplemental filing to expand Igalmi's label for at-home use in Q1 2026.

结果显示，在2400多集里症状持续减轻。它现在将支持FDA补充备案，以在2026年第一季度扩展Igalmi的家庭使用标签。

Efficacy in institutional settings was already established in SERENITY I and II.

在机构环境中的疗效已在SERENITY I和II中得到证实。

Also Read:

另请阅读：

BioXcel Therapeutics’ Approved Drug For Bipolar Disorders/Schizophrenia Shows No Evidence Of Worsening Or Withdrawal In Post-Marketing Study

BioXcel Therapeutics获批的双相情感障碍/精神分裂症药物在上市后研究中未显示恶化或戒断的证据

A higher percentage of patients receiving BXCL501 achieved full resolution of mild-to-severe agitation compared with placebo, with consistent benefits observed on repeat dosing.

接受BXCL501治疗的患者中，更高比例的患者实现了从轻度到重度躁动的完全缓解，重复给药时观察到一致的益处。

The 120 mcg dose was well-tolerated, met the primary endpoint, and caused no discontinuations. Adverse events aligned with the approved Igalmi label and prior institutional trials.

120微克剂量耐受性良好，达到了主要终点，且未导致任何中断。不良事件与已批准的Igalmi标签和先前的机构试验一致。

Full Phase 3 analyses are ongoing, with additional results to be presented at upcoming medical meetings.

完整的三期分析正在进行中，更多结果将在即将到来的医学会议上公布。

Igalmi is FDA-approved for acute agitation in bipolar I/II disorder or schizophrenia in supervised settings and is available in 120 mcg and 180 mcg doses.

Igalmi 获 FDA 批准用于在受监管环境下治疗双相 I/II 型障碍或精神分裂症的急性躁动，有 120 微克和 180 微克两种剂量可供使用。

Previous estimates of 23 million annual agitation episodes, based on historic claims, assumed 1.2 episodes per patient per month. Recent market research and surveys suggest 3–4 episodes monthly, mostly moderate to severe.

基于历史数据的每年2300万次躁动发作的早期估计，假设每位患者每月发生1.2次发作。然而，最近的市场研究和调查显示，每月发作次数为3到4次，且大多为中度至重度。

Data from 2,600+ episodes in the SERENITY At-Home Phase 3 trial support this higher frequency, suggesting 57–77 million annual at-home episodes in the U.S.

SERENITY 在家第三阶段试验中 2600 多集的数据支持了这一更高频率，表明美国每年在家发生的集数为 5700 万至 7700 万。

Price Action:

价格行为：

BTAI stock is down 11.45% at $4.64 at the last check on Wednesday.

周三最后一次检查时，BTAI股票下跌11.45%，至4.64美元。

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