<p>周五，美国食品药品监督管理局（FDA）批准了 <strong>Milestone Pharmaceuticals Inc.</strong> (NASDAQ: MIST) 的首个商业产品，Cardamyst (etripamil) 鼻用喷雾剂。</p>
<p>该批准涵盖了将阵发性室上性心动过速（PSVT）急性症状发作转化为窦性心律的成年人治疗。</p>
<p>Cardamyst 预计将在 2026 年第一季度 在零售药店上市。</p>
<p><strong><em>另请阅读: 为什么 Milestone Pharmaceuticals 的股票在周五暴跌？</em></strong></p>
<h2>数十年来的首个新治疗选择</h2>
<p>该批准使 Cardamyst 成为 30 多年来 FDA 批准的首个治疗超过 200 万名 PSVT 患者的药物。</p>
<p>Cardamyst 鼻用喷雾剂是一种新型快速作用的钙通道阻滞剂，在需要时用于治疗常常高度症状化和不可预测的 PSVT 发作。</p>
<p>PSVT 是一种心律失常，心脏的上腔在突发的短暂发作中非常快速地跳动，因心脏电气 “短路” 而突然开始和停止，导致心悸、头晕、呼吸急促和胸痛。</p>
<h2>临床试验数据与疗效</h2>
<p>Cardamyst 的 FDA 批准得到了基于超过 1800 名参与者和超过 2000 次 PSVT 发作的安全性数据的临床试验项目的支持。</p>
<p>在临床研究中，使用 Cardamyst 的参与者将症状性 PSVT 转化为窦性心律的可能性是安慰剂的两倍，且转化速度超过安慰剂三倍。</p>
<p>RAPID 试验达到了其主要终点，64% 的自我给药 Cardamyst 的参与者（N=99）在 30 分钟内从室上性心动过速（SVT）转化为窦性心律，而安慰剂组为 31%（N=85）。</p>
<p>在一小时后，73% 的参与者显示出益处。此外，使用 Cardamyst 的参与者在转化时间上显著缩短，转化的中位时间为 17 分钟，而安慰剂组为 54 分钟。</p>
<p><strong>MIST 价格动态：</strong> 周五，Milestone Pharmaceuticals 的股票在盘前交易中上涨了 30.73%，报 3.15 美元。该股票交易价格创下 52 周新高，根据 Benzinga Pro 数据。</p>
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<li><strong>能源存储推动锂回收，市场预计进一步收紧</strong></li>
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<p><em>图片来源于 Shutterstock</em></p>

MIST

<p>Milestone Pharmaceuticals 的 Cardamyst 鼻用喷雾剂已获得 FDA 批准，用于治疗成人急性阵发性室上性心动过速（PSVT），这是 30 多年来首个新治疗方法。该喷雾剂是一种快速作用的钙通道阻滞剂，预计将在 2026 年第一季度进入药店。临床试验显示其显著疗效，与安慰剂相比，能够更快恢复窦性心律。公告发布后，Milestone 的股票上涨了 30.73%，创下 52 周新高</p>

<p>On Friday, the U.S. Food and Drug Administration (FDA) approved <strong>Milestone Pharmaceuticals Inc.’s</strong> (NASDAQ: MIST) first commercial product, Cardamyst (etripamil) nasal spray.</p>
<div class="lb-trans"><p>周五，美国食品药品监督管理局（FDA）批准了 <strong>Milestone Pharmaceuticals Inc.</strong> (NASDAQ: MIST) 的首个商业产品，Cardamyst (etripamil) 鼻用喷雾剂。</p>
</div><p>The approval covers the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.</p>
<div class="lb-trans"><p>该批准涵盖了将阵发性室上性心动过速（PSVT）急性症状发作转化为窦性心律的成年人治疗。</p>
</div><p>Cardamyst is expected to be available in retail pharmacies in the first quarter of 2026.</p>
<div class="lb-trans"><p>Cardamyst 预计将在 2026 年第一季度 在零售药店上市。</p>
</div><p><strong><em>Also Read: Why Is Milestone Pharmaceuticals Stock Plunging On Friday?</em></strong></p>
<div class="lb-trans"><p><strong><em>另请阅读: 为什么 Milestone Pharmaceuticals 的股票在周五暴跌？</em></strong></p>
</div><h2>First New Treatment Option In Decades</h2>
<div class="lb-trans"><h2>数十年来的首个新治疗选择</h2>
</div><p>The approval marks Cardamyst as the first FDA-approved treatment in over 30 years for more than 2 million Americans with PSVT.</p>
<div class="lb-trans"><p>该批准使 Cardamyst 成为 30 多年来 FDA 批准的首个治疗超过 200 万名 PSVT 患者的药物。</p>
</div><p>Cardamyst nasal spray is a novel and rapid-acting calcium channel blocker delivered when needed to treat often highly symptomatic and unpredictable episodes of PSVT.</p>
<div class="lb-trans"><p>Cardamyst 鼻用喷雾剂是一种新型快速作用的钙通道阻滞剂，在需要时用于治疗常常高度症状化和不可预测的 PSVT 发作。</p>
</div><p>PSVT is a type of arrhythmia where the heart’s upper chambers beat very fast in sudden, brief episodes, starting and stopping abruptly due to a heart’s electrical “short circuit,” causing palpitations, dizziness, shortness of breath, and chest pain.</p>
<div class="lb-trans"><p>PSVT 是一种心律失常，心脏的上腔在突发的短暂发作中非常快速地跳动，因心脏电气 “短路” 而突然开始和停止，导致心悸、头晕、呼吸急促和胸痛。</p>
</div><h2>Clinical Trial Data And Efficacy</h2>
<div class="lb-trans"><h2>临床试验数据与疗效</h2>
</div><p>The FDA approval of Cardamyst is supported by a clinical trial program based on safety data from more than 1,800 participants and more than 2,000 episodes of PSVT.</p>
<div class="lb-trans"><p>Cardamyst 的 FDA 批准得到了基于超过 1800 名参与者和超过 2000 次 PSVT 发作的安全性数据的临床试验项目的支持。</p>
</div><p>In clinical studies, participants using Cardamyst were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo.</p>
<div class="lb-trans"><p>在临床研究中，使用 Cardamyst 的参与者将症状性 PSVT 转化为窦性心律的可能性是安慰剂的两倍，且转化速度超过安慰剂三倍。</p>
</div><p>The RAPID trial achieved its primary endpoint with 64% of those who self-administered Cardamyst (N=99) converting from supraventricular tachycardia (SVT) to sinus rhythm within 30 minutes compared to 31% on placebo (N=85).</p>
<div class="lb-trans"><p>RAPID 试验达到了其主要终点，64% 的自我给药 Cardamyst 的参与者（N=99）在 30 分钟内从室上性心动过速（SVT）转化为窦性心律，而安慰剂组为 31%（N=85）。</p>
</div><p>At one hour, the benefit was demonstrated in 73% of participants. In addition, significant reductions in time to conversion in those who took Cardamyst were evident early and durable, with a median time to conversion of 17 minutes for those treated with Cardamyst vs. 54 minutes for those treated with placebo.</p>
<div class="lb-trans"><p>在一小时后，73% 的参与者显示出益处。此外，使用 Cardamyst 的参与者在转化时间上显著缩短，转化的中位时间为 17 分钟，而安慰剂组为 54 分钟。</p>
</div><p><strong>MIST Price Action:</strong> Milestone Pharmaceuticals shares were up 30.73% at $3.15 during premarket trading on Friday. The stock is trading at a new 52-week high, according to Benzinga Pro data.</p>
<div class="lb-trans"><p><strong>MIST 价格动态：</strong> 周五，Milestone Pharmaceuticals 的股票在盘前交易中上涨了 30.73%，报 3.15 美元。该股票交易价格创下 52 周新高，根据 Benzinga Pro 数据。</p>
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</div><p><em>Image via Shutterstock</em></p>
<div class="lb-trans"><p><em>图片来源于 Shutterstock</em></p>
</div>

Milestone 获得 FDA 批准，用于突发快速心跳的首个自用鼻喷剂