– Expanded indication for ZYNRELEF now covers approximately 13 million procedures annually –

–ZYNRELEF的扩展适应症现在每年涵盖约1300万个程序–

SAN DIEGO, Jan. 23, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the 'FDA') has approved its supplemental New Drug Application ('NDA') for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided.

圣地亚哥，2024年1月23日/PRNewswire/--Heron Therapeutics，Inc.（纳斯达克：HRTX），一家商业阶段的生物技术公司，今天宣布，美国食品和药物管理局（FDA）已批准其ZYNRELEF®（布比卡因和美洛昔康）缓释溶液的补充新药申请（NDA），以扩大软组织和整形外科手术（包括足踝）的适应症，以及其他避免直接暴露于关节软骨的手术。

ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults..

ZYNRELEF先前已被批准用于成人足踝部，中小腹部和下肢全关节置换手术。。

This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty.

ZYNRELEF的扩大适应症现在每年估计将涵盖1300万个手术，比之前的指定手术估计增加86%。为了获得这种标记扩展，Heron成功地进行了剖宫产，脊柱手术，隆乳术和全肩关节置换术的研究。

No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following ZYNRELEF administration..

新的临床试验没有发现独特的安全性问题，布比卡因和美洛昔康的血药浓度与ZYNRELEF给药后的先前经验一致。。

'The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures. The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle ('VAN') later this year, are expected to have a significant positive impact for ZYNRELEF and the Company,' said Craig Collard, Chief Executive Officer of Heron..

“扩大的适应症有望对患者护理产生变革性影响，为医疗保健专业人员提供一种通用而有效的解决方案，用于在更广泛的外科手术中管理术后疼痛。Heron首席执行官克雷格·科拉德（CraigCollard）表示，新标签的扩张以及最近与CrossLink的合作，再加上今年晚些时候可能批准的小瓶接入针（“VAN”），预计将对ZYNRELEF和公司产生重大的积极影响。。

'We're excited for the opportunity to give even more healthcare providers and patients a new, safe and effective option for achieving long-lasting non-opioid pain control after painful surgical procedures,' said Bill Forbes, Executive Vice President, Chief Development Officer at Heron. 'This new approval further reinforces our commitment to providing meaningful solutions to address unmet medical needs in the acute care and oncology settings.'.

Heron执行副总裁兼首席开发官比尔·福布斯（BillForbes）说：“我们很高兴有机会为更多的医疗保健提供者和患者提供一种新的、安全有效的选择，以在痛苦的外科手术后实现持久的非阿片类疼痛控制。”这项新的批准进一步加强了我们提供有意义的解决方案的承诺，以解决急性护理和肿瘤学环境中未满足的医疗需求。”。

ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. ZYNRELEF demonstrated superiority compared to bupivacaine with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. ZYNRELEF was initially approved by the FDA in May 2021 and received approval of the first supplemental NDA for an expanded label in December 2021..

ZYNRELEF是第一个也是唯一一个在3期研究中经过严格测试的术后疼痛管理疗法，并证明其优于布比卡因溶液（目前的护理标准）。与布比卡因相比，ZYNRELEF表现出优越性，疼痛评分较低，经历严重疼痛的患者较少，阿片类药物消耗量较低。ZYNRELEF最初于2021年5月获得FDA批准，并于2021年12月获得第一份扩展标签的补充NDA批准。。

'Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like ZYNRELEF now available for additional orthopedic procedures is a great benefit to have in my practice,' said Alexander Sah, M.D., orthopedic surgeon at Sah Orthopaedic Associates.

“接受整形外科手术的患者经常会经历剧烈的疼痛，减慢他们的恢复时间，并可能导致其他并发症。Sah orthopedic Associates的整形外科医生亚历山大·萨赫（AlexanderSah）医学博士（AlexanderSah）说，在头三天内减轻患者的疼痛对患者满意度至关重要，现在有一种像ZYNRELEF这样的产品可用于其他整形外科手术，这对我的实践是一个很大的好处。

'ZYNRELEF helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use.'.

“ZYNRELEF帮助我的患者完全康复，更快出院，疼痛明显减轻，几乎不使用阿片类药物。”。

Important Safety Information for Patients

患者的重要安全信息

ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:

ZYNRELEF含有NSAID（非甾体抗炎药），这是一种药物，可以：

Can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.

会增加心脏病发作或中风的风险，从而导致死亡。这种风险随着NSAID剂量的增加和使用时间的延长而增加。

Cannot be used during heart bypass surgery.

心脏搭桥手术期间不能使用。

Can increase the risk of gastrointestinal bleeding, ulcers, and tears.

会增加胃肠道出血、溃疡和眼泪的风险。

ZYNRELEF should also not be used:

也不应使用ZYNRELEF：

if you are allergic to any component of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines.

如果您对ZYNRELEF的任何成分、类似的局部麻醉药、阿司匹林或其他非甾体抗炎药（如布洛芬或萘普生）过敏，或者服用这些药物后出现哮喘发作、荨麻疹或其他过敏反应。

as a paracervical block, during childbirth.

在分娩期间作为宫颈旁阻滞。

The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache.

ZYNRELEF最常见的副作用是软组织手术：呕吐和整形手术：便秘和头痛。

The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia)..

ZYNRELEF（一种局部麻醉药和非甾体抗炎药）中的药物可能会影响神经和心血管系统；可能导致肝脏或肾脏问题；可能会降低某些降压药的作用；如果你有严重的心力衰竭，应该避免；可能对软骨产生不利影响；可能导致罕见的血液疾病，或危及生命的皮肤或过敏反应；如果在怀孕20周或以后接受，可能会伤害您的未出生婴儿；并可能导致红细胞减少（贫血）。。

Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you.

告诉你的医疗保健提供者你的所有医疗状况以及你服用的所有药物，包括处方药或非处方药、维生素或草药补充剂，以讨论ZYNRELEF是否适合你。

Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

向你的医疗保健提供者咨询有关副作用的医疗建议。向Heron（电话1-844-437-6611）或FDA（电话1-800-FDA-1088）或www.FDA.gov/medwatch报告副作用。

The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning.

这里提供的信息不全面。请参阅完整的处方信息，包括盒装警告。

About ZYNRELEF for Postoperative PainZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

关于术后疼痛的ZYNRELEF ZYNRELEF是第一种也是唯一一种双作用局部麻醉药，它提供局部麻醉药布比卡因和低剂量非甾体抗炎药美洛昔康的固定剂量组合。与布比卡因溶液（目前用于术后疼痛控制的标准护理局部麻醉剂）相比，ZYNRELEF是第一种也是唯一一种在3期研究中证明显着减轻疼痛并在术后72小时内不需要阿片类药物的患者比例显着增加的缓释局部麻醉剂。

ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the 'FDA') in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

ZYNRELEF最初于2021年5月获得美国食品和药物管理局（“FDA”）的批准，用于成人软组织或关节周围滴注，以在bunionectomy，开放性腹股沟疝修补术和全膝关节置换术后产生长达72小时的术后镇痛。2021年12月，FDA批准将ZYNRELEF的适应症扩大到包括足踝，中小腹部开放和下肢全关节置换手术。

On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

2024年1月23日，FDA批准ZYNRELEF用于软组织和整形外科手术，包括足踝，以及其他避免直接暴露于关节软骨的手术。高度血管手术的安全性和有效性尚未确定，例如胸内，大型多节段脊柱和头颈部手术。

ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch.

ZYNRELEF于2020年9月获得欧盟委员会的上市许可，并于2021年1月获得英国监管局的上市许可。2023年8月，我们取消了ZYNRELEF英国市场营销授权，2023年10月，我们取消了ZYNRELEF欧盟（EU）市场营销授权，因为我们不打算商业化推出。

About Heron Therapeutics, Inc.Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.

关于Heron Therapeutics，Inc.Heron Therapeutics，Inc.是一家商业阶段的生物技术公司，专注于通过开发和商业化改善医疗保健的治疗创新来改善患者的生活。我们先进的科学、专利技术和创新的药物发现和开发方法使我们能够创建和商业化一系列产品，旨在提高急性护理和肿瘤患者的护理标准。

For more information, visit www.herontx.com..

有关更多信息，请访问www.herontx.com。。

Forward-looking StatementsThis news release contains 'forward-looking statements' as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, uncertainties related to market conditions; the potential market opportunities for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; the net product sales guidance for the oncology care franchise and the acute care franchise; the EBITDA guidance provided by the Company; the results of the commercial launch of APONVIE; the potential additional market opportunity for the approved expanded U.S.

前瞻性声明本新闻稿包含1995年《私人证券诉讼改革法案》定义的“前瞻性声明”。Heron提醒读者，截至本新闻发布之日，前瞻性陈述是基于管理层的预期和假设，并受到某些风险和不确定性的影响，这些风险和不确定性可能导致实际结果产生重大差异，包括但不限于与市场状况相关的不确定性；ZYNRELEF、APONVIE、CINVANTI和SUSTOL的潜在市场机会；肿瘤护理特许经营权和急性护理特许经营权的净产品销售指南；公司提供的息税折旧摊销前利润指导；APONVIE商业发布的结果；经批准的扩展美国的潜在额外市场机会。

label for ZYNRELEF; the timing of the Company's development of the VAN program; the timing of the Company's submission of the PAS to the FDA for the VAN; the timing of the FDA's review process and whether the FDA approves the PAS for the VAN; the outcome of the Company's pending ANDA litigation related to CINVANTI; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; any inability or delay in achieving profitability; and other risks and uncertainties identified in the Company's filings with the U.S.

ZYNRELEF标签；公司开发面包车项目的时间安排；公司向FDA提交面包车PAS的时间；FDA审查过程的时间安排以及FDA是否批准面包车的PAS；公司与CINVANTI相关的未决ANDA诉讼的结果；公司未来是否需要注销任何额外库存；Heron现金、现金等价物和短期投资的预期未来余额；Heron的现金、现金等价物和短期投资余额为其运营提供资金的预期期限，以及未来可能需要股权融资的风险；无法或延迟实现盈利能力；以及该公司向美国提交的文件中确定的其他风险和不确定性。

Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these state.

证券交易委员会。前瞻性声明仅在声明日期反映我们的分析，Heron没有义务更新或修改这些状态。

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

请参阅www.ZYNRELEF.com上的完整处方信息，包括盒装警告。

Investor Relations and Media Contact:

投资者关系和媒体联系：

Ira DuarteExecutive Vice President, Chief Financial OfficerHeron Therapeutics, Inc.[email protected] 858-251-4400

Ira Duarte首席财务官执行副总裁Heron Therapeutics，Inc.[受电子邮件保护]858-251-4400

SOURCE Heron Therapeutics, Inc.

来源Heron Therapeutics，Inc。