Cumberland Pharmaceuticals Inc. , a specialty pharmaceutical company with a focus on hospital acute care, today announced the launch of Caldolor® Injection in a ready-to-use bag that may be administered without dilution for pain relief. This launch follows FDA approval in 2019 of the product's new delivery method.
A non-steroidal anti-inflammatory drug (NSAID), Caldolor may be used as the sole method of treatment for mild-moderate pain or as part of a multi-modal treatment for severe pain. Thus it is positioned to play an important role in combatting the nation's opioid crisis, which claims the lives of over 130 Americans a day, according to The Centers for Disease Control and Prevention.
Even short-term opioid use after surgery can lead to long-term addiction. Prompt and appropriate pain management is vital to mitigating opioid use. Published data for Caldolor supports administration just prior to surgery and throughout the postoperative period. As a result patients experience significantly less pain upon awakening, then remain in significantly less pain, while also reducing their opioid consumption.
"We have been encouraged by the significant number of physicians who have incorporated Caldolor into their pain management regimens as a way to combat the negative effects of opioid use," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "The new ready-to-use presentation of Caldolor offers hospitals and other medical facilities a proven product that is now easier to administer and, thus, has the potential to further reduce opioid use."
Caldolor possesses three key therapeutic properties: anti-inflammatory, analgesic and antipyretic action. Uncontrolled inflammation may contribute to hypersensitivity to pain and lead to chronic post-operative pain. Pre-empting this response with Caldolor may reduce the need for continued post-operative opioids and improve recovery through reduction in opioid-related side effects, such as nausea, vomiting and constipation.
The new formulation of Caldolor comes in a pre-mixed bag containing 800 mg of ibuprofen in a 200 mL patented low sodium formulation for injection that is ready to use. It is the first and only FDA-approved pre-mixed bag of ibuprofen. Caldolor is still available as an 800 mg/8mL single–dose vial (100mg/mL) for dilution in addition to the ready-to-use bag (4 mg/mL). The new, premixed presentation provides healthcare professionals a formulation that is easy to administer, helping manage the treatment of patient pain and fever, while reducing opioid consumption.
Prudent and careful management of pain is among the most important responsibilities of every healthcare provider. New strategies are emerging to control acute and chronic pain in the hospital setting, and Cumberland has provided grants in support of educational webinars in partnership with two of the nation's leading physician services companies. Through these initiatives, three webinars have been developed that introduce healthcare providers to new therapies and pain modalities for more effective pain management. These accredited webinars recognize that many patients are first introduced to opioids in a hospital or surgery center setting and, in some cases, may become dependent upon or even abuse their opioid treatments. This cycle can be avoided through the introduction of non-opioid medications like Caldolor which can serve as the basis for multimodal strategies to improve pain management.
There is a growing body of published evidence showing that Caldolor can significantly decrease both surgical pain and opioid use. One clinical study, conducted at The Ohio State Wexner Medical Center, assessed the efficacy of Caldolor compared to ketorolac for the treatment of postoperative pain in patients undergoing arthroscopic knee surgery, and it revealed more effective pain control and opioid-sparing activity with Caldolor when compared to ketorolac. The results of this study demonstrated that the use of IV ibuprofen, compared to IV ketorolac, significantly lowered postoperative pain scores and opioid consumption in patients undergoing arthroscopic knee surgeries.
Another study, conducted at Tufts University School of Dental Medicine in Boston, compared the preemptive analgesic effects of Caldolor to IV acetaminophen in controlling post-surgical pain and reliance on opioids for rescue pain control. The study investigators concluded that preemptive anesthesia with Caldolor IV ibuprofen is superior when compared to IV acetaminophen in reducing post-surgical pain and opioid use.
Cumberland has recently completed a clinical study for the use of Caldolor in patients from birth to 6 months of age. This comes after the Company conducted clinical trials and received FDA approval which extended the approved adult use to use in children aged 6 months to 17 years old. Topline results from the newborn study are forthcoming and will add to the growing body of literature that supports the safety and efficacy of the product.
Caldolor can be a key component in cost effective Enhanced Recovery After Surgery (ERAS) multimodal treatment protocols. Clinical studies of Caldolor demonstrate:
Caldolor is indicated in adults and pediatric patients six months and older for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It should be noted that Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic-type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, including boxed warning, visit www.caldolor.com.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high quality prescription brands to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care and gastroenterology market segments. These medical specialties are categorized by moderately concentrated prescriber bases that we believe can be penetrated effectively by targeted sales forces. The Company's portfolio of FDA approved brands includes:
For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company's website www.cumberlandpharma.com.
The Company has Phase II clinical programs underway evaluating its ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD"), Hepatorenal Syndrome ("HRS") and Portal Hypertension ("PH").
This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding our intent, belief or expectations. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure and other factors discussed in the Company's most recent Form 10-K and subsequent 10-Q's as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.
SOURCE Cumberland Pharmaceuticals Inc.
专注于医院急性护理的专业制药公司 Cumberland Pharmaceuticals Inc .今天宣布，将推出 Caldolor ®注射液，该产品可以在不稀释疼痛缓解效果的情况下使用。本次上市遵循 FDA 于2019年批准的该产品新的交货方式。
非甾体抗炎药（ NSAID ）可作为治疗轻度中度疼痛的唯一方法，也可作为治疗重度疼痛的多模式治疗的一部分。根据疾病控制和预防中心的说法，它在对抗美国的阿片类药物危机中扮演着重要的角色。
即使手术后短期使用阿片类药物也会导致长期上瘾。及时和适当的疼痛管理对于缓解阿片类药物的使用至关重要。发表的数据为 Caldolor 支持行政之前，手术和整个术后期间。因此，患者在觉醒时经历的疼痛明显减少，然后在明显减少疼痛，同时减少阿片类药物的消耗。
坎伯兰制药公司首席执行官 A.J . Kazimi 说：“许多医生将 Caldodor 纳入疼痛管理方案，以此来对抗阿片类药物使用的负面影响，这让我们感到鼓舞。”Caldodor 的新的可使用的演示为医院和其他医疗设施提供了一种已证实的产品，现在更易于管理，因此有可能进一步减少阿片类药物的使用。
Caldolor 具有抗炎、镇痛、解热三大治疗作用。未控制的炎症可能导致对疼痛的过敏症，并导致术后慢性疼痛。预先使用 Caldolor 缓解可能会减少术后继续使用阿片类药物的需要，并通过减少与阿片类药物相关的副作用（如恶心、呕吐和便秘）来改善恢复。
新配方的 Caldolor 是在预混袋含有800毫克布洛芬在200毫升专利低钠制剂注射准备使用。这是 FDA 批准的第一个也是唯一的布洛芬预混袋。除了即用袋（4mg / mL ）外，还可以作为800 mg /8mL 单剂量瓶（100mg / mL ）进行稀释。新的预混合制剂为医疗保健专业人员提供了一种易于管理的配方，帮助管理治疗病人疼痛和发烧，同时减少阿片类药物的消耗。
谨慎和谨慎的疼痛管理是每个医疗保健提供者最重要的责任之一。新的战略正在出现，以控制急性和慢性疼痛的医院设置，坎伯兰提供赠款支持教育网络研讨会与两个国家的领先的医生服务公司。通过这些举措，开发了三个网络研讨会，向医疗保健提供者介绍新的治疗方法和疼痛模式，以更有效的疼痛管理。这些经认可的网络研讨会认识到，许多患者首先被介绍到医院或手术中心的阿片类药物，在某些情况下，可能依赖或甚至滥用其阿片类药物治疗。通过引入像 Caldodor 这样的非阿片类药物，可以避免这种循环，它可以作为改善疼痛管理的多模式策略的基础。
越来越多的已发表的证据表明， Caldodor 可以显著减少手术疼痛和阿片类药物的使用。在俄亥俄州 Wexner 医疗中心进行的一项临床研究，评估了 Caldolor 与酮咯咯酸治疗关节镜下膝关节手术患者术后疼痛的疗效，发现与酮咯酸相比， Caldolor 具有更有效的疼痛控制和阿片保存活性。研究结果表明，与静脉酮咯酸相比，静脉布洛芬的使用显著降低了关节镜下膝关节手术患者术后疼痛评分和阿片类药物的消耗。
另一项在波士顿 Tufts 大学牙科医学院进行的研究，比较了 Caldoor 和 IV 乙酰氨基酚在控制术后疼痛和依赖阿片类药物进行抢救疼痛控制方面的先发制人镇痛效果。研究人员得出结论，在减少术后疼痛和阿片类药物使用方面，使用 Caldoor IV 布洛芬的先发制性麻醉优于使用 IV 乙酰对乙酰氨基酚。
坎伯兰最近完成了一项临床研究，用于从出生到6个月年龄的患者使用 Caldolor 。在此之前，公司进行了临床试验，并获得 FDA 批准，将批准的成人使用范围扩大到6个月至17岁的儿童。新出生的研究结果即将发表，并将增加越来越多的文献支持产品的安全性和有效性。
Caldolor 可以是成本有效增强术后恢复（ ERAS ）多模式治疗方案的关键组成部分。临床研究表明：
在成人和儿童患者中，六个月及六个月以上的钙调剂用于治疗轻度至中度疼痛和治疗中度至重度疼痛作为阿片类药物镇痛剂的辅助药物，以及减少发烧。应该注意的是，对于已知对布洛芬或其他非甾体抗炎药过敏症的患者，服用阿司匹林或其他非甾体抗炎药后有哮喘病史或其他过敏型反应的患者，使用 Caldoor 是禁忌的。冠状动脉旁路移植术（ CABG ）围手术期不宜使用卡多洛尔。对于有溃疡或 GI 出血病史的患者、有液体潴留或心力衰竭的患者、老年人、有肾功能损害、心衰、肝功能损害的患者以及服用利尿剂或 ACE 抑制剂的患者，应谨慎使用 Caldolor 。治疗期间应监测血压。有关详细处方信息，包括盒装警告，请访问 www.caldolor.com 。
坎伯兰制药有限公司是一家专注于提供优质处方品牌以改善患者护理的特色制药企业。本公司开发、收购及商业化医院急重症监护及胃肠病学细分市场的品牌。这些医学专科是按适度集中的处方基础分类的，我们相信可以通过有针对性的销售队伍有效渗透。本公司的 FDA 批准品牌组合包括：
有关坎伯兰批准产品的更多信息，包括完整的处方信息，请访问个别产品网站，其链接可在本公司网站 www.dougandPharmaceuticals.com 上找到。
本公司现正进行第二期临床计划，评估与杜氏肌萎缩症（「 DMD 」）、系统性硬化（「 SSc 」）及 Aspirin-Exerated 呼吸疾病（「 AERD 」）、 Hepatronal Syndrome （「 HRS 」）及门静脉高压有关的心肌病患者的 ifetroban 产品候选者。
本新闻稿包含前瞻性声明，这些声明具有一定的风险，并反映了坎伯兰基于其认为合理的假设对未来事件的当前观点。无法保证这些事件会发生。前瞻性陈述包括（其中包括）关于我们的意图、信念或期望的陈述。与任何业务一样，坎伯兰经营的所有阶段都受到其无法控制的因素的影响，这些因素的任何一个或组合都可能对坎伯兰的经营业绩产生重大影响。这些因素包括市场条件、竞争、制造商不能及时生产坎伯兰的产品或制造商未能遵守适用于制药制造商的条例，保持公司向 SEC 提交的最新10-K 表格和随后的10-Q 表格中讨论的有效销售和营销基础设施及其他因素。无法保证公司预期的结果会实现或会产生预期效果。读者应注意不要过度依赖前瞻性陈述，这些陈述仅在本协议签订之日起生效。本公司不承担任何义务公开修改这些报表，以反映本协议日期之后的事件。