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Vertex Pharmaceuticals Incorporated

Vertex制药公司

(Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. JOURNAVX is an effective, well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain..

（纳斯达克：VRTX）今天宣布，美国食品和药物管理局（FDA）已批准JOURNAVX™（suzetrigine），一种口服非阿片类高选择性NaV1.8疼痛信号抑制剂，用于治疗中度至重度急性疼痛的成年人。JOURNAVX是一种有效的，耐受性良好的药物，没有成瘾潜力的证据，适用于所有类型的中度至重度急性疼痛。。

“Today’s approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “With the approval of JOURNAVX, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”.

Vertex首席执行官兼总裁ReshmaKewalramani医学博士说：“今天的批准对于美国每年有8000万人服用中重度急性疼痛药物来说是一个历史性的里程碑。”。“随着非阿片类药物疼痛信号抑制剂JOURNAVX的批准，以及20多年来批准的第一类新型疼痛药物，我们有机会改变急性疼痛管理的范式，建立新的护理标准。”。

“This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” said Jessica Oswald, M.D., M.P.H., Associate Physician in Emergency Medicine and Pain Medicine in San Diego and Vertex Acute Pain Steering Committee Member.

“对于患者和医生来说，这是一个令人难以置信的日子，他们现在已经获得批准的非阿片类药物治疗，可以有效缓解急性疼痛，并具有良好的安全性，而不会产生成瘾的可能性，”圣地亚哥急诊医学和疼痛医学副医师、Vertex急性疼痛指导委员会成员杰西卡·奥斯瓦尔德（JessicaOswald）说。

“I believe JOURNAVX could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed.”.

“我相信JOURNAVX可以重新定义疼痛的管理，并成为所有类型中度至重度急性疼痛患者的基础治疗选择，除了阿片类药物之外，其他选择都是迫切需要的。”。

As part of Vertex’s ongoing commitment to patients, the company has established patient support programs to help ensure that qualified patients can access JOURNAVX. For more information visit

作为Vertex对患者持续承诺的一部分，该公司建立了患者支持计划，以帮助确保合格的患者可以访问JOURNAVX。

JOURNAVX.com

Journavx.com

.

.

About Acute Pain

Acute pain is a serious and potentially disabling condition often caused by surgery, accident or injury. Over 80 million Americans are prescribed medicine to treat their moderate-to-severe acute pain every year. Of these, about 40 million are prescribed an opioid. Nearly 10% of acute pain patients treated initially with an opioid will go on to have prolonged opioid use, and about 85,000 patients will develop opioid use disorder annually.

急性疼痛是一种严重且可能致残的疾病，通常由手术，事故或伤害引起。每年有8000多万美国人开处方药治疗中度至重度急性疼痛。其中，约有4000万人服用阿片类药物。最初接受阿片类药物治疗的急性疼痛患者中，近10%会继续长期使用阿片类药物，每年约有85000名患者会出现阿片类药物使用障碍。

Poorly controlled acute pain can lead to reduced quality of life, development of chronic pain, and increased burden on the health care system and society..

急性疼痛控制不佳会导致生活质量下降，慢性疼痛发展，并增加医疗保健系统和社会的负担。。

About JOURNAVX™ (suzetrigine)

JOURNAVX (suzetrigine) is a first-in-class, oral, non-opioid, highly selective pain signal inhibitor that is selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials).

JOURNAVX（suzetrigine）是一种一流的口服非阿片类高选择性疼痛信号抑制剂，相对于其他NaV通道对NaV1.8具有选择性。NaV1.8是一种电压门控钠通道，在外周疼痛感应神经元（伤害感受器）中选择性表达，其作用是传递疼痛信号（动作电位）。

Because JOURNAVX blocks pain signals only found in the periphery, not in the brain, JOURNAVX provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids..

由于JOURNAVX阻断了仅在外周而非大脑中发现的疼痛信号，因此JOURNAVX可以有效缓解疼痛，而不受目前可用疗法的限制，包括阿片类药物的成瘾潜力。。

The U.S. Food and Drug Administration approved twice-daily JOURNAVX for the treatment of adults with moderate-to-severe acute pain. Vertex has established a wholesale acquisition cost for JOURNAVX in the United States of $15.50 per 50mg pill.

美国食品和药物管理局批准每日两次JOURNAVX用于治疗中度至重度急性疼痛的成年人。Vertex已确定JOURNAVX在美国的批发收购成本为每50mg药丸15.50美元。

Vertex is also evaluating suzetrigine in peripheral neuropathic pain (PNP). The company’s Phase 3 pivotal program for suzetrigine in patients with painful diabetic peripheral neuropathy is ongoing, and Vertex plans to advance its pivotal program evaluating suzetrigine in patients with painful lumbosacral radiculopathy pending discussions with regulators..

Vertex还在评估suzetrigine治疗周围神经性疼痛（PNP）。该公司针对疼痛性糖尿病周围神经病变患者的suzetrigine的第三阶段关键计划正在进行中，Vertex计划在与监管机构讨论之前，推进其评估suzetrigine治疗疼痛性腰骶神经根病患者的关键计划。。

INDICATION and IMPORTANT SAFETY INFORMATION FOR JOURNAVX

JOURNAVX的指示和重要安全信息

™

™

(suzetrigine)

（叹息）

INDICATION AND USAGE

适应症和用法

JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short term (acute) pain.

JOURNAVX是一种处方药，用于治疗患有中度至重度短期（急性）疼痛的成年人。

It is not known if JOURNAVX is safe and effective in children.

目前尚不清楚JOURNAVX对儿童是否安全有效。

IMPORTANT SAFETY INFORMATION

重要安全信息

Patients should not take JOURNAVX

患者不应服用JOURNAVX

if they take certain medicines that are strong inhibitors of an enzyme called CYP3A. Patients should ask their healthcare providers if they are not sure.

如果他们服用某些强烈抑制CYP3A酶的药物。如果患者不确定，应该询问他们的医疗保健提供者。

Before taking JOURNAVX, patients should tell their healthcare provider about all of their medical conditions, including if they:

在服用JOURNAVX之前，患者应该告诉他们的医疗保健提供者他们的所有医疗状况，包括他们是否：

have liver problems. People with liver problems may have an increased risk of getting side effects from taking JOURNAVX;

有肝脏问题。患有肝病的人服用JOURNAVX可能会增加副作用的风险；

are pregnant or plan to become pregnant as it is not known if JOURNAVX will harm an unborn baby. Patients and their healthcare providers should decide if they will take JOURNAVX while they are pregnant,

怀孕或计划怀孕，因为不知道JOURNAVX是否会伤害未出生的婴儿。患者及其医疗保健提供者应决定是否在怀孕期间服用JOURNAVX，

are breastfeeding, or are planning to breastfeed, as it is not known if JOURNAVX passes into breast milk. Patients and their healthcare providers should decide if they will take JOURNAVX while they are breastfeeding.

正在母乳喂养或计划母乳喂养，因为不知道JOURNAVX是否会进入母乳。患者及其医疗保健提供者应决定是否在母乳喂养期间服用JOURNAVX。

Patients should tell their healthcare provider about all the medicines they take,

患者应该告诉他们的医疗保健提供者他们服用的所有药物，

including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking JOURNAVX with certain other medicines may affect the way JOURNAVX and the other medicines work and may increase patients’ risk of side effects. Patients should ask their healthcare provider or pharmacist for a list of these medicines if they are not sure..

包括处方药和非处方药、维生素和草药补充剂。与某些其他药物一起服用JOURNAVX可能会影响JOURNAVX和其他药物的工作方式，并可能增加患者产生副作用的风险。如果患者不确定，应向其医疗保健提供者或药剂师索要这些药物的清单。。

Patients should especially tell their healthcare provider if they take hormonal birth control medicine (contraceptives) containing progestins

如果患者服用含有孕激素的激素节育药（避孕药），应特别告知医疗保健提供者

other than

levonorgestrel or norethindrone. If they take one of these contraceptives (progestins other than levonorgestrel or norethindrone), they may not work as well during treatment with JOURNAVX. Patients should also use nonhormonal contraceptives such as condoms or use other forms of hormonal birth control during treatment with JOURNAVX and for 28 days after they stop taking JOURNAVX.

左炔诺孕酮或炔诺酮。如果他们服用其中一种避孕药（除左炔诺孕酮或炔诺酮以外的孕激素），在使用JOURNAVX治疗期间可能效果不佳。患者在接受JOURNAVX治疗期间以及停止服用JOURNAVX后28天内，还应使用避孕套等非激素避孕药或其他形式的激素节育。

Medicines that are substrates of the CYP3A enzyme may become less effective during treatment with JOURNAVX. Their healthcare provider may need to adjust the dose of patients’ medicine when starting or stopping JOURNAVX. Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.

在用JOURNAVX治疗期间，作为CYP3A酶底物的药物可能会变得不那么有效。在开始或停止JOURNAVX时，他们的医疗保健提供者可能需要调整患者的药物剂量。患者应该知道他们服用的药物，并保存一份药物清单，以便在他们服用新药时向他们的医疗保健提供者和药剂师展示。

.

.

Patients should

患者应该

not take food or drink containing grapefruit while taking JOURNAVX.

服用JOURNAVX时不要吃含葡萄柚的食物或饮料。

JOURNAVX can cause side effects:

JOURNAVX可能会产生副作用：

The most common side effects for patients treated with JOURNAVX include itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment. Patients should talk to their healthcare provider if they have concerns about becoming pregnant.

JOURNAVX治疗的患者最常见的副作用包括瘙痒，肌肉痉挛，肌酸磷酸激酶血液水平升高和皮疹。JOURNAVX可能会暂时降低女性在治疗期间怀孕的机会。如果患者担心怀孕，应该与他们的医疗保健提供者交谈。

If patients are using contraceptives, continue to use contraceptives during treatment with JOURNAVX. Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away. These are not all of the possible side effects of JOURNAVX. Patients should call their healthcare provider for medical advice about side effects.

如果患者正在使用避孕药，请在使用JOURNAVX治疗期间继续使用避孕药。患者应该告诉他们的医疗保健提供者，如果他们有任何困扰他们或不会消失的副作用。这些并不是JOURNAVX可能产生的所有副作用。患者应致电医疗保健提供者，征求有关副作用的医疗建议。

Patients may report side effects to the FDA at 1-800-FDA-1088..

患者可通过1-800-FDA-1088向FDA报告副作用。。

Please

求你了

click here

单击此处

for the full Prescribing Information, including Patient Information, for JOURNAVX.

有关JOURNAVX的完整处方信息，包括患者信息。

About Vertex

关于顶点

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple serious diseases and conditions — cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain — and continues to advance clinical and research programs in these areas.

Vertex是一家全球生物技术公司，投资于科学创新，为患有严重疾病的人创造变革性药物。该公司已批准用于治疗多种严重疾病和病症的潜在原因的药物-囊性纤维化，镰状细胞病，输血依赖性β地中海贫血和急性疼痛-并继续推进这些领域的临床和研究计划。

Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1..

Vertex还在其他严重疾病的一系列模式中拥有强大的临床研究治疗渠道，对因果人类生物学有深入的了解，包括神经性疼痛，APOL1介导的肾脏疾病，IgA肾病，原发性膜性肾病，常染色体显性遗传性多囊肾病，1型糖尿病和1型强直性营养不良。。

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For.

Vertex成立于1989年，全球总部位于波士顿，国际总部位于伦敦。此外，该公司在北美、欧洲、澳大利亚、拉丁美洲和中东设有研发基地和商业办事处。Vertex一直被公认为行业最佳工作地点之一，包括连续15年入选《科学》杂志的最佳雇主名单，以及《财富》杂志的100家最佳工作公司之一。

For company updates and to learn more about Vertex's history of innovation, visit .

有关公司更新和Vertex创新历史的更多信息，请访问。

www.vrtx.com

www.vrtx.com

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Special Note Regarding Forward-Looking Statements

关于前瞻性声明的特别说明

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements made by Reshma Kewalramani, M.D., and Jessica Oswald, M.D., M.P.H., in this press release and statements regarding the expectations for the potential benefits of JOURNAVX, expectations that JOURNAVX provides pain relief without the limitations of currently available therapies, including the addictive potential of opioids, expectations for the eligible patient population, plans for and status of our clinical trials evaluating suzetrigine in diabetic peripheral neuropathy, and plans to advance the pivotal program evaluating suzetrigine in patients with painful lumbosacral radiculopathy pending discussions with regulators.

本新闻稿包含经修订的1995年《私人证券诉讼改革法案》中定义的前瞻性声明，包括但不限于医学博士Reshma Kewalramani和医学博士Jessica Oswald在本新闻稿中的声明，以及关于JOURNAVX潜在益处的期望，JOURNAVX在不受现有疗法限制的情况下缓解疼痛的期望，包括阿片类药物的成瘾潜力，对符合条件的患者人群的期望，我们评估糖尿病周围神经病变中suzetrigine的临床试验的计划和状态，以及计划推进评估腰骶部疼痛患者中suzetrigine的关键计划神经根病有待与监管机构讨论。

While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements.

虽然Vertex认为本新闻稿中包含的前瞻性陈述是准确的，但这些前瞻性陈述仅代表截至本新闻稿发布之日的公司信念，并且存在许多风险和不确定性，可能导致实际事件或结果与此类前瞻性陈述所表达或暗示的事件或结果存在重大差异。

Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under the heading “Risk Factors” in Vertex's annual report and in subsequent filings filed with the Securities and Exchange Commission and available through the company's website at .

这些风险和不确定性包括，除其他外，由于安全性、有效性或其他原因，公司开发计划的数据可能不支持其化合物的注册或进一步开发，以及Vertex年度报告和随后提交给证券交易委员会的文件中“风险因素”标题下列出的其他风险，并可通过公司网站获取。

www.vrtx.com

www.vrtx.com

and

和

www.sec.gov

www.sec.gov

. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

。您不应过度依赖这些声明。Vertex不承担在新信息可用时更新本新闻稿中包含的信息的任何义务。

(VRTX-GEN)

（VRTX-GEN）