Vertex Pharmaceuticals is vying for approval of an experimental and closely watched painkiller that could become an alternative to addictive opioids like Vicodin.

Vertex Pharmaceuticals正在争取批准一种实验性且备受关注的止痛药，该止痛药可能成为维可丁等成瘾性阿片类药物的替代品。

On Thursday, the biotechnology company said the Food and Drug Administration granted a so-called rolling review of the drug, a pill previously known as VX-548 and now suzetrigine, in moderate-to-severe acute pain. Vertex has already started the process and expects to complete an approval filing in the second quarter..

周四，这家生物技术公司表示，美国食品和药物管理局批准了对该药物进行所谓的滚动审查，该药物以前称为VX-548，现在称为suzetrigine，用于中度至重度急性疼痛。Vertex已开始该流程，预计将在第二季度完成审批备案。。

Suzetrigine is an important drug for Vertex, which has spent years trying to branch out from the cystic fibrosis medicines that account for much of its revenue. The drug has already succeeded in the types of Phase 3 studies several other would-be pain therapies have failed in recent years, positioning itself as the first of what could be a new class of medicines that don’t have the addictive properties of opioids..

Suzetrigine是Vertex的一种重要药物，Vertex多年来一直试图从占其收入大部分的囊性纤维化药物中分拆出来。该药物已经在3期研究中取得了成功，近年来其他几种可能的疼痛疗法也失败了，将其定位为第一种可能是不具有阿片类药物成瘾特性的新型药物。。

Some analysts believe suzetrigine could generate billions of dollars in peak annual sales if approved, much more than the gene editing treatment Vertex brought to market last year.

一些分析师认为，如果获得批准，suzetrigine可能会在年销售额高峰时产生数十亿美元的收入，远远超过Vertex去年推向市场的基因编辑疗法。

Thursday’s announcement brings that potential outcome a bit closer. The FDA has already given the company certain designations meant to speed up the review process, which typically takes six to ten months. A “rolling” review also enables a developer to work hand-in-hand with regulators in an often faster and more collaborative process..

周四的宣布使这一潜在结果更加接近。美国食品和药物管理局（FDA）已经为该公司指定了某些名称，以加快审查过程，通常需要六到十个月的时间。“滚动式”审查还使开发人员能够与监管机构携手合作，以更快、更具协作性的方式进行。。

“Today marks a significant milestone on our journey to redefine the treatment of pain,” said Carmen Bozic, Vertex’s chief medical officer, in a statement. “Given the favorable benefit/risk profile demonstrated by suzetrigine across the entire clinical program and the positive interactions with regulators, we are excited by the opportunity to rapidly advance suzetrigine, a new non-opioid potential treatment, for the millions of patients suffering from acute and peripheral neuropathic pain.”.

Vertex首席医疗官卡门·博齐奇（CarmenBozic）在一份声明中表示：“今天标志着我们重新定义疼痛治疗之旅的一个重要里程碑。”。“鉴于suzetrigine在整个临床计划中表现出良好的益处/风险概况以及与监管机构的积极互动，我们很高兴有机会迅速推进suzetrigine，一种新的非阿片类药物潜在治疗方法，用于数百万患有急性和周围神经性疼痛的患者。”。

Suzetrigine still faces questions. The drug missed a key secondary goal in Phase 3 trials in acute pain, failing to prove more effective than a combination of Tylenol and a widely prescribed opioid. That finding, as well as the potential that insurers could require prior authorization before approving treatment, may “cap its usage” in the post-operative setting, RBC Capital Markets analyst Brian Abrahams wrote in a note to investors earlier this month..

Suzetrigine仍然面临着问题。该药物在急性疼痛的3期试验中错过了一个关键的次要目标，未能证明其比泰诺和广泛处方的阿片类药物的组合更有效。RBC资本市场分析师布莱恩·亚伯拉罕（BrianAbrahams）在本月早些时候给投资者的一份报告中写道，这一发现以及保险公司在批准治疗前可能需要事先授权的可能性，可能会在术后环境中“限制其使用”。。

Abrahams believes peak annual sales in acute pain will only reach about $400 million annually, substantially lower than consensus analyst estimates of about $2 billion.

亚伯拉罕斯认为，急性疼痛的年销售额峰值每年只会达到约4亿美元，远低于分析师普遍估计的约20亿美元。

“We continue to see a good likelihood of approval, given sufficient data and the need for opioid sparing pain drugs, though we remain much more cautious on the market opportunity,” Abrahams added in a note on Thursday.

Abrahams在周四的一份报告中补充道：“鉴于足够的数据和对阿片类止痛药的需求，我们继续看到批准的可能性很大，尽管我们对市场机会仍持谨慎态度。”。

Commercial prospects for the drug could be higher if it succeeds in other forms of pain. Vertex on Thursday disclosed plans to run two late-stage trials in diabetic peripheral neuropathy, a larger indication in which suzetrigine showed promise in earlier testing. The company also expects to finish enrolling participants in a Phase 2 trial in lumbosacral radiculopathy, a form of chronic pain, by the end of the year..

如果该药物在其他形式的疼痛中取得成功，其商业前景可能会更高。Vertex周四透露，计划在糖尿病周围神经病变中进行两项晚期试验，这是suzetrigine在早期试验中显示出前景的更大迹象。该公司还预计在年底前完成腰骶神经根病（一种慢性疼痛）2期试验的参与者登记。。

Separately, Vertex is developing another, similar type of pain drug, VX-993, and expects to start Phase 2 tests later this year. A Phase 1 trial of a version of VX-993 delivered intravenously should begin in 2024 as well.

另外，Vertex正在开发另一种类似类型的止痛药VX-993，预计今年晚些时候开始第二阶段测试。静脉注射VX-993版本的第一阶段试验也应于2024年开始。