安杰索（美洛昔康）注射液

公司名称：Baudax Bio，Inc.

批准日期：2020年2月20日

Anjeso（美洛昔康）是一种NSAID注射剂，可单独或与非NSAID镇痛药一起用于成年人中度至重度疼痛的管理。

2020年2月20日，宾夕法尼亚州马尔文（GLOBE NEWSWIRE）-专注于急性护理环境疗法的制药公司Baudax Bio，Inc.（NASDAQ：BXRX）今天宣布，美国食品药品监督管理局（FDA）已批准用于Anjeso（美洛昔康注射液）的新药申请（NDA），该药可单独或与其他非NSAID镇痛药联合用于治疗中度至重度疼痛。

Baudax Bio总裁兼首席执行官Gerri Henwood表示：“ Anjeso的批准标志着治疗中度至重度疼痛的治疗领域取得了重大进步。” “由于我们的国家目前正处于阿片类药物的全国性流行之中，我们很高兴能够提供一种新颖的非阿片类药物治疗选择，并有可能对急性疼痛治疗范例产生有意义的影响。我们希望在2020年4月下旬或5月初向医生和患者开放Anjeso。”

Anjeso已获批准用于中度至重度疼痛的治疗，并将以每日一次的静脉（IV）快速推注方式给药。 Anjeso是唯一可用的24小时静脉（IV）COX-2优先非甾体类抗炎药（NSAID），每天提供一次。活性成分美洛昔康是一种长效，优先使用的COX-2抑制剂，具有镇痛，抗炎和退烧的活性，据信与抑制环氧合酶2型途径（COX-2）和随后前列腺素的降低有关。生物合成。

Baudax Bio首席医学官Stewart McCallum博士说：“ Anjeso的安全性和有效性已经通过一些中后期临床研究得到了很好的确立。” “此外，来自我们第三阶段安全性试验的数据表明，与安慰剂相比，Anjeso具有很好的耐受性并影响了阿片类药物的消费，进一步凸显了其对患者，医疗服务提供者和医疗系统的价值。”

“鉴于疼痛治疗领域对非阿片类药物的需求尚未得到满足，Anjeso的批准标志着医学界的一项重要成就，”美国大学麻醉，围手术医学和疼痛管理学系主任Keith Candiotti博士说。迈阿密。 “虽然传统的阿片类药物已被证明可有效缓解疼痛，但相关的不良副作用，包括镇静和呼吸抑制，已促使医生采用多模式方法来治疗术后疼痛。 Anjeso具有24小时持久的止痛效果和可与安慰剂媲美的安全性，因此有潜力作为有意义的差异化镇痛药。”

Anjeso的批准由两项III期功效研究和一项双盲，安慰剂对照的III期安全研究支持。这些研究的结果以及四个II期临床研究和其他安全性研究的结果均包含NDA软件包。

在≥2％的接受Anjeso治疗且频率比安慰剂高的患者中，最常见的不良反应包括：便秘，γ-谷氨酰转移酶升高和贫血。

除了下面提供的全部重要安全信息外，请参阅公司网站www.baudaxbio.com上的“新闻与投资者”部分，以获取完整的处方信息。

Baudax预计Anjeso将于2020年4月下旬或5月初在美国上市。有关更多信息，请访问www.baudaxbio.com。

ANJESO™综合临床试验

第三阶段疗效研究评估肛肠切除术后的安耶索

在这项多中心，随机，双盲，安慰剂对照的临床试验中，纳入201位患者并随机分配其以1：1的比例接受安杰索（30mg）或安慰剂的术后治疗方案，每24小时一次，最多3次足切除术后的剂量，代表硬组织手术。与安慰剂组相比，Anjeso治疗组的SPID48降低了统计学意义（p = 0.0034）。该研究还实现了19个次要终点中的15个，包括SPID6（p = 0.0153），SPID12（p = 0.0053），SPID24（p = 0.0084），SPID24-48（p = 0.0050），首次使用时间的统计显着性差异与安慰剂相比，在开始的48小时内有多少种急救药物（p = 0.0076）和其他几种急救使用和疼痛缓解指标。安全性结果表明，接受Anjeso治疗的患者对Anjeso的耐受性良好，没有严重的不良事件或出血事件。

评估腹部整形手术后的Anjeso的第三阶段功效研究

在这项多中心，随机，双盲，安慰剂对照的临床试验中，每24小时招募219名患者，并随机分配它们以1：1的比例接受安杰索（30毫克推注）或安慰剂的术后治疗方案。与安慰剂组相比，Anjeso治疗组的SPID24降低了统计学意义（p = 0.0145）。该研究还达到了10个次要终点的统计学意义，包括SPID12的统计学差异（p = 0.0434），疼痛缓解时间（p = 0.0050），24小时≥30％改善的受试者（p = 0.0178） ，与安慰剂相比，患者在随机分配后的前24小时需要抢救的次数（p = 0.0275），以及从24到48小时得到抢救的次数（p = 0.0009），以及其他几种缓解疼痛的指标。安全性结果表明，对Anjeso治疗的患者与安慰剂（各1例）对Anjeso的耐受性良好，与出血相关的严重不良事件（SAE）没有差异。

第三阶段安全性研究评估大手术后的Anjeso

这项多中心，随机，双盲，安慰剂对照的III期临床试验包括接受重大择期手术的患者，预计这些患者将住院至少24-48小时。主要的外科手术包括全髋关节和膝关节置换术，脊柱，胃肠道，疝气修补术，妇科手术以及一系列其他手术。各个治疗组之间的患者人口统计是平衡的，其中包括40％的男性患者和约23％的65岁以上的患者。与关键功效试验不同，治疗不需要最低疼痛评分。根据患者的“护理标准”，允许其使用阿片类药物和其他疼痛控制方式，并在该方案中添加了美洛昔康或安慰剂。患者以3：1的比例随机分配，每天接受安杰索或静脉安慰剂，最多7剂。共有721名患者接受了至少一剂研究药物。在65岁及以上的患者中，与安慰剂组相比，Anjeso治疗组中报告至少一种AE的患者百分比降低了约7％。 Anjeso组的发生至少一种严重不良事件（SAE）的患者的总发生率低于安慰剂组的2.6％（14/538美洛昔康患者），比安慰剂组的5.5％（10/183安慰剂患者）低）。在该安全性研究中，仅列出了两个可能与研究治疗相关的SAE事件。这两种SAE均发生在一名接受安慰剂治疗的患者中。两个治疗组均无死亡报告。每个研究组中约有3％的患者停药。

适应症和用途

Anjeso可单独或与非NSAID镇痛药一起用于成人中度至重度疼痛的治疗。

使用限制：由于镇痛作用延迟，当需要快速镇痛作用时，不建议单独使用Anjeso。

重要安全信息

警告：严重心血管和胃肠道疾病的风险

心血管风险

非甾体类抗炎药（NSAIDs）导致发生严重心血管血栓事件的风险增加，包括心肌梗塞和中风，这可能是致命的。这种风险可能在治疗初期发生，并可能随着使用时间的增加而增加。

Anjeso在冠状动脉旁路移植术（CABG）手术中是禁忌的。

胃肠道风险

NSAIDs引起严重胃肠道（GI）不良事件的风险增加，包括出血，溃疡和胃或肠穿孔可能是致命的。这些事件可以在使用期间的任何时间发生，而不会出现警告症状。老年患者和有消化性溃疡疾病和/或胃肠道出血史的患者更有可能发生严重的胃肠道事件。

禁忌症

Anjeso禁用于以下患者：

对美洛昔康或药物产品的任何成分的已知超敏反应（例如，过敏反应和严重的皮肤反应）。

服用阿司匹林或其他非甾体抗炎药后有哮喘，荨麻疹或其他变态反应的病史。

在设置冠状动脉搭桥术（CABG）的手术中。

中度至重度肾功能不全的患者，由于容量减少而存在肾衰竭的风险

警告和注意事项

肝毒性：NSAIDs患者中有ALT或AST升高的报道。另外，已经报道了罕见的，有时是致命的严重肝损伤病例，包括暴发性肝炎，肝坏死和肝功能衰竭。告知患者肝毒性的警告信号和症状。如果异常肝试验持续或恶化或出现肝病的临床体征和症状，请立即停用安杰索。

高血压：包括Anjeso在内的NSAID可能导致高血压的新发作或既往高血压的恶化，这可能导致心血管事件发生率增加。服用非甾体抗炎药时，服用某些降压药的患者对这些疗法的反应可能受损。监测血压。

心力衰竭和水肿：使用NSAID会增加心肌梗塞（MI），心力衰竭住院和死亡的风险。除非预期会带来的好处超过使心力衰竭恶化的风险，否则应避免在患有严重心力衰竭的患者中使用Anjeso。如果在严重心力衰竭患者中使用Anjeso，请监测患者是否有心力衰竭恶化的迹象。

MI后患者：除非预期收益大于复发性CV血栓形成事件的风险，否则避免在新近MI患者中使用Anjeso。如果在这些患者中使用Anjeso，请监测心脏缺血的迹象。

肾毒性：长期服用NSAID会导致肾乳头坏死，肾功能不全，急性肾衰竭和其他肾损伤。不建议在中度至重度肾功能不全的患者中使用Anjeso，而在中度至重度肾功能不全的患者中禁忌使用Anjeso，这些患者由于体质消耗而可能导致肾衰竭。在开始Anjeso之前，应纠正脱水或低血容量患者的正确体积状态。监测肾或肝功能不全，心力衰竭，脱水或血容量不足的患者的肾功能。除非预期收益会超过肾功能恶化的风险，否则应避免在晚期肾脏疾病患者中使用Anjeso。如果在患有晚期肾脏疾病的患者中使用Anjeso，请监测患者肾功能恶化的迹象。

过敏反应：在对美洛昔康过敏和不知道对美洛昔康过敏的患者以及对阿司匹林敏感的哮喘患者中，美洛昔康与过敏反应相关。如果发生过敏反应，请寻求紧急帮助。

与阿司匹林敏感性有关的哮喘加重：对阿司匹林敏感的哮喘患者禁用安杰索。监测患有哮喘的患者（无阿司匹林敏感性）。

严重的皮肤反应：包括Anjeso在内的NSAID会引起严重的皮肤反应，包括剥脱性皮炎，史蒂文斯-约翰逊综合症（SJS）和中毒性表皮坏死溶解（TEN），这可能是致命的，并且可能在无预警的情况下发生。初次出现皮疹或其他超敏反应迹象时，请停止使用Anjeso。

血液毒性：NSAID治疗的患者发生贫血。监测有贫血迹象或症状的患者的血红蛋白或血细胞比容。包括Anjeso在内的NSAID可能会增加出血事件的风险。监视患者是否有出血迹象。

药物相互作用

干扰止血的药物（例如，华法林，阿司匹林，SSRI / SNRI）：监测患者同时服用止血药和干扰止血药物的出血情况。一般不建议同时使用Anjeso和止痛剂量的阿司匹林。

血管紧张素转换酶（ACE）抑制剂，血管紧张素受体阻滞剂（ARB）或β受体阻滞剂：与Anjeso并用可能会降低这些药物的降压作用。监测血压。

ACE抑制剂和ARB：在老年人，容量不足或患有肾功能不全的老年人中与Anjeso并用可能会导致肾功能恶化。在此类高危患者中，监测肾功能恶化的迹象。

利尿剂：非甾体抗炎药可降低速尿和噻嗪类利尿剂的利钠作用。监视患者以确保利尿功效，包括抗高血压作用。

不良反应

在对照临床试验中，≥2％的接受Anjeso治疗的患者发生的最常见不良反应发生率高于安慰剂，包括：便秘，γ-谷氨酰转移酶升高和贫血。

在特定人群中的使用

怀孕：在妊娠晚期使用非甾体抗炎药会增加动脉导管早闭的风险。从妊娠30周开始，避免在孕妇中使用NSAID。

不育症：NSAID与可逆性不育症相关。考虑在受孕困难的女性中退出Anjeso。

请在www.baudaxbio.com上查看完整的处方信息，包括盒装警告。

关于Anjeso™

Anjeso（美洛昔康）注射液是一种专有的长效优先COX-2抑制剂，具有镇痛，抗炎和退烧的活性，据信与抑制环氧合酶2型途径（COX-2）及随后的作用有关。减少前列腺素的生物合成。 Anjeso于2020年2月获得美国食品和药物管理局的批准，可单独或与其他非NSAID镇痛药联合用于中度至重度疼痛的管理。由于镇痛作用延迟，当需要快速镇痛作用时，不建议单独使用Anjeso。该公司预计将在2020年4月下旬或2020年5月初推出ANJESO。Anjeso产品的批准得到两项关键的III期临床疗效试验，一项大型的双盲，安慰剂对照的III期安全试验和四项II期临床疗效试验的支持，以及其他安全性研究。作为非阿片类药物，Baudax Bio认为ANJESO有可能克服与通常处方的阿片类药物治疗有关的许多问题，包括呼吸抑制，便秘，恶心和呕吐，并且没有成瘾性，同时保持有意义的镇痛作用减轻疼痛ANJESO是使用NanoCrystal®平台设计的，该技术可提高水溶性差的药物化合物的生物利用度。 NanoCrystal®是Alkermes Pharma Ireland Limited（APIL）的注册商标。

关于Baudax Bio，Inc.

Baudax Bio是一家专业制药公司，专注于急性护理环境中的疗法。该公司的主要产品候选药物是美洛昔康（一种非阿片类药物，每天一次，优先使用的COX-2抑制剂）的专有静脉（IV）形式。 IV美洛昔康已成功完成了两项关键的III期临床疗效试验，大型双盲安慰剂对照的III期安全试验，四项II期临床疗效试验以及其他安全性研究。作为非阿片类药物，静脉注射美洛昔康具有克服与通常处方的阿片类药物治疗相关的许多问题的潜力，包括呼吸抑制，便秘，恶心和呕吐，并且在保持有意义的止痛效果以缓解疼痛方面没有成瘾性。疼痛。有关更多信息，请访问www.baudaxbio.com。

Source: Baudax Bio, Inc.

Posted: February 2020

Anjeso (meloxicam) Injection

Company: Baudax Bio, Inc.

Date of Approval: February 20, 2020

Anjeso (meloxicam) is an NSAID injection indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

MALVERN, Pa., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Anjeso (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

“The approval of Anjeso marks a major advancement in the treatment landscape for managing moderate to severe pain,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “With our nation currently in the midst of a national opioid epidemic, we are thrilled to be able to offer a novel, non-opioid therapeutic option with the potential to meaningfully impact the acute pain treatment paradigm.  We expect to make Anjeso available to physicians and patients in late April or early May 2020.”

Anjeso is approved for the management of moderate to severe pain and will be administered as a once-a-day intravenous (IV) bolus push. Anjeso is the only available 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) and offers once-daily dosing.  The active ingredient meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis.

“The safety and efficacy of Anjeso have been well-established through several mid- and late-stage clinical studies,” said Stewart McCallum, M.D., Chief Medical Officer of Baudax Bio. “Moreover, data from our Phase III safety trial demonstrated that Anjeso is well tolerated and impacted opioid consumption compared to placebo, further highlighting its value to patients, providers and health systems.”

“The approval of Anjeso marks an important achievement for the medical community given the unmet need for non-opioid options in the pain treatment landscape,” said Dr. Keith Candiotti chair of the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami.  “While traditional opioid medications have proven effective at providing pain relief, the associated adverse side effects, including sedation and respiratory depression, have driven physicians to employ a multi-modal approach to treating post-operative pain. With 24-hour, durable pain relief and a safety profile comparable to placebo, Anjeso has the potential to serve as a meaningfully differentiated analgesic alternative.”

The Anjeso approval is supported by two Phase III efficacy studies and one double-blind, placebo-controlled Phase III safety study.  The results from these studies, as well as results from four Phase II clinical studies and other safety studies, comprised the NDA package.

The most common ADVERSE REACTIONS reported in ≥2% of patients treated with Anjeso and at a greater frequency than placebo included: constipation, gamma-glutamyl transferase increased and anemia.

Please see “News & Investors” section of the Company’s website at www.baudaxbio.com for full Prescribing Information in addition to the full Important Safety Information provided below.

Baudax expects Anjeso will be available in the U.S. in late April or early May 2020.  For more information, visit www.baudaxbio.com.

ANJESO™ COMPREHENSIVE CLINICAL TRIALS

Phase 3  Efficacy Study Evaluating Anjeso Following Bunionectomy Surgery

In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 201 patients were enrolled and randomly assigned to receive a postoperative regimen of Anjeso (30mg) or placebo in a 1:1 ratio, once every 24 hours for up to 3 doses following bunionectomy surgery, a representative hard tissue surgery. The Anjeso treatment arm demonstrated a statistically significant reduction in SPID48 (p=0.0034) compared to the placebo arm. The study also achieved 15 of the 19 secondary endpoints, including statistically significant differences in SPID6 (p=0.0153), SPID12 (p=0.0053), SPID24 (p=0.0084), SPID24-48 (p=0.0050), time to first use of rescue medication (p=0.0076), and several other rescue use and pain relief metrics during the first 48 hours, compared to placebo. The safety results demonstrated that Anjeso was well tolerated with no serious adverse events or bleeding events in the Anjeso-treated patients.

Phase 3 Efficacy Study Evaluating Anjeso Following Abdominoplasty Surgery

In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 219 patients were enrolled and randomly assigned to receive a postoperative regimen of Anjeso (30mg bolus injection) or placebo in a 1:1 ratio, once every 24 hours. The Anjeso treatment arm demonstrated a statistically significant reduction in SPID24 (p=0.0145) compared to the placebo arm.  The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12 (p=0.0434), time to perceptible pain relief (p=0.0050), subjects with ≥30% improvement at 24 hours (p=0.0178), number of times patients required rescue in the first 24 hours after randomization (p=0.0275), as well as number of times rescued from 24 to 48 hours (p=0.0009), and several other pain relief metrics, compared to placebo. The safety results demonstrated that Anjeso was well tolerated with no difference in serious adverse events (SAEs) related to bleeding for Anjeso treated patients versus placebo (1 each).

Phase 3 Safety Study Evaluating Anjeso Following Major Surgery

This multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, included patients who had undergone major elective surgical procedures which were expected to result in hospitalization for at least 24-48 hours. Major surgical procedures included total hip and knee replacements, spinal, GI, hernia repair, and gynecologic surgeries, as well as a range of other surgeries.  Patient demographics were balanced across treatment groups and included 40% male patients and about 23% of patients who were over age 65.  Unlike the pivotal efficacy trials, minimum pain scores were not required for treatment.  Sites were permitted to use opioids and other pain management modes according to their “standard of care” and meloxicam or placebo was added to this regimen.  Patients were randomized in a 3:1 ratio to receive either Anjeso or IV placebo daily for up to 7 doses.  A total of 721 patients received at least one dose of study medication. In patients age 65 and over, the percentage of patients reporting at least one AE was approximately 7% less in the Anjeso treatment arm compared to the placebo arm.  The total occurrence of patients with at least one serious adverse event (SAE) was observed to be lower in the Anjeso group, 2.6%, (14/538 meloxicam patients) than in the placebo group, 5.5%, (10/183 placebo patients).  In this safety study only two SAE events were listed as possibly related to study treatment. Both of these SAEs occurred in one placebo treated patient. No deaths were reported in either treatment group.  Approximately 3% of patients in each study group discontinued.

INDICATION AND USAGE

Anjeso is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

Limitation of Use: Because of delayed onset of analgesia, Anjeso alone is not recommended for use when rapid onset of analgesia is required.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Risk

· Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

· Anjeso is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

· NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CONTRAINDICATIONS

Anjeso is contraindicated in patients with:

· Known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product.

· History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

· In the setting of coronary artery bypass graft (CABG) surgery.

· Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue Anjeso immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Hypertension: NSAIDs including Anjeso can lead to new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of cardiovascular (CV) events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: NSAID use increased the risk of myocardial infarction (MI), hospitalization for heart failure, and death. Avoid use of Anjeso in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If Anjeso is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Post MI Patients: Avoid the use of Anjeso in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Anjeso is used in these patients, monitor for signs of cardiac ischemia.

Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury. Anjeso is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency who are at risk for renal failure due to volume depletion. Correct volume status in dehydrated or hypovolemic patients prior to initiating Anjeso. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of Anjeso in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. If Anjeso is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

Exacerbation of Asthma Related to Aspirin Sensitivity: Anjeso is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

Serious Skin Reactions: NSAIDs, including Anjeso, can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue Anjeso at first appearance of skin rash or other signs of hypersensitivity.

Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including Anjeso, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

DRUG INTERACTIONS

Drugs That Interfere With Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking Anjeso with drugs that interfere with hemostasis. Concomitant use of Anjeso and analgesic doses of aspirin is not generally recommended.

Angiotensin Converting Enzymes (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with Anjeso may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

ACE Inhibitors and ARBs: Concomitant use with Anjeso in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to ensure diuretic efficacy including antihypertensive effects.

ADVERSE REACTIONS

The most common adverse reactions in controlled clinical trials occurring in ≥ 2% of patients treated with Anjeso and at a greater frequency than placebo include:  constipation, gamma-glutamyl transferase increased, and anemia.

USE IN SPECIFIC POPULATIONS

Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of Anjeso in women who have trouble conceiving.

Please see full Prescribing Information, including Boxed Warning at www.baudaxbio.com. 

Anjeso (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis.  Anjeso was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.  Because of the delayed onset of analgesia, Anjeso alone is not recommended for use when rapid onset of analgesia is required.  The Company expects to launch ANJESO in late April or early May 2020.  The Anjeso product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies.  As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain.  ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company’s lead product candidate is a proprietary intravenous (IV) form of meloxicam, a non-opioid, once a day preferential COX-2 inhibitor. IV meloxicam has successfully completed two pivotal Phase III clinical efficacy trials, a large double-blind placebo-controlled Phase III safety trial, four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," “goal”, "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, our ability to maintain regulatory approval for Anjeso™, our ability to successfully commercialize Anjeso™;  the acceptance of Anjeso™ by the medical community, including physicians, patients, health care providers and hospital formularies; our ability and that of our third party manufacturers to successfully scale-up our commercial manufacturing process for Anjeso™, our ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for Anjeso™, our ability to raise future financing for continued product development and Anjeso™ commercialization, our ability to manage costs and execute on our operational and budget plans, the accuracy of our estimates of the potential market for Anjeso™, our ability to achieve our financial goals; and our ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. The forward-looking statements in this press release should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov.

Source: Baudax Bio, Inc.

Posted: February 2020