STAMFORD, Conn.--(BUSINESS WIRE)--Purdue Pharma L.P. (“Purdue”) announced today that the company has partnered with MMCAP Infuse to provide buprenorphine and naloxone tablets CIII (generic Suboxone®), a medication for opioid use disorder (“MOUD”), at low cost to correctional facilities for incarcerated individuals with opioid use disorder.

康涅狄格州斯坦福德——（商业新闻短讯）——普渡制药有限公司（Purdue Pharma L.P.）今天宣布，该公司已与MMCAP Infuse合作，以较低的成本向被监禁的阿片类药物使用障碍患者的惩教机构提供丁丙诺啡和纳洛酮片剂CIII（generic Suboxone®），这是一种治疗阿片类药物使用障碍（“MOUD”）的药物。

MMCAP Infuse is a national cooperative group purchasing organization operated by the State of Minnesota, Office of State Procurement, for government facilities that provide healthcare services. Under the agreement, to increase access to treatment for incarcerated individuals, Purdue will provide for distribution approximately 1.25 million tablets at the cost of one penny ($0.01) per tablet..

MMCAP Infuse是由明尼苏达州政府采购办公室运营的国家合作团体采购组织，用于提供医疗服务的政府设施。根据该协议，为了增加被监禁者的治疗机会，普渡大学将提供大约125万片药片，每片药片一便士（0.01美元）。。

The Office of National Drug Control Policy (“ONDCP”) reports that substance use disorder affects an estimated 65 percent of incarcerated individuals, 1 and correctional facilities often face cost barriers in providing adequate substance use disorder treatment.2 Moreover, according to ONDCP, research shows that individuals leaving prison face a “meaningful elevated risk” of opioid overdose death [up to 40 times higher] than that of the general population during the first two weeks following their release.1,3 However, research also indicates that treatment with MOUDs during incarceration can reduce the risk of drug overdose death in the first month post release by 85 percent.1.

国家药物管制政策办公室（ONDCP）报告称，据估计，65%的被监禁者受到药物使用障碍的影响，1而惩教机构在提供适当的药物使用障碍治疗方面往往面临成本障碍。2此外，根据ONDCP的研究，研究表明，离开监狱的人在获释后的头两周内面临阿片类药物过量死亡的“有意义的高风险”[高达40倍]。1,3然而，研究还表明，在监禁期间使用MOUD治疗可以将释放后第一个月的药物过量死亡风险降低85%。

“Our agreement with MMCAP Infuse supports the objectives identified by ONDCP and other government agencies that have emphasized the need to expand access to MOUD for incarcerated individuals,” said Craig Landau, MD, President and CEO of Purdue. “Unfortunately, too many in this patient population are left in need of treatment.

普渡大学总裁兼首席执行官、医学博士克雷格·兰道（CraigLandau）表示：“我们与MMCAP Infuse达成的协议支持ONDCP和其他政府机构确定的目标，这些机构强调有必要扩大被监禁者获得MOUD的机会。”。“不幸的是，这个患者群体中有太多人需要治疗。

We are committed to delivering solutions to help with this complex crisis and working with partners such as MMCAP Infuse to bring medication to those who need it most.”.

我们致力于提供解决方案来帮助应对这场复杂的危机，并与MMCAP Infuse等合作伙伴合作，为最需要的人提供药物。”。

This buprenorphine/naloxone tablet distribution effort is an important part of Purdue’s Public Health Initiatives, which focus on the development and distribution of medicines that reverse opioid overdoses and treat opioid use disorder. Rhodes Pharmaceuticals, a wholly owned subsidiary of Purdue, distributes this medication..

这项丁丙诺啡/纳洛酮片剂分销工作是普渡公共卫生倡议的重要组成部分，该倡议侧重于开发和分销逆转阿片类药物过量和治疗阿片类药物使用障碍的药物。罗德斯制药公司是普渡大学的全资子公司，经销这种药物。。

Buprenorphine and Naloxone Sublingual Tablets CIII

丁丙诺啡纳洛酮舌下含片CIII

INDICATIONS AND USAGE

适应症和用法

Buprenorphine and naloxone sublingual tablets are indicated for maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.

丁丙诺啡和纳洛酮舌下含片适用于阿片类药物依赖的维持治疗。丁丙诺啡和纳洛酮舌下片剂应作为包括咨询和心理社会支持在内的完整治疗计划的一部分。

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONS

禁忌症

Buprenorphine and naloxone sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported.

丁丙诺啡和纳洛酮舌下片剂禁用于对丁丙诺啡或纳洛酮过敏史的患者，因为据报道有严重的不良反应，包括过敏性休克。

WARNINGS AND PRECAUTIONS

警告和注意事项

Addiction, Abuse, and Misuse​

成瘾、虐待和滥用​

Buprenorphine and naloxone sublingual tablets contain buprenorphine which can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.

丁丙诺啡和纳洛酮舌下片剂含有丁丙诺啡，可以类似于其他阿片类药物的方式滥用。监测患者是否存在阿片类药物依赖和成瘾行为转移或进展的迹象。不应在治疗早期或没有适当的患者随访时开具多次补液的处方。

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Risk of Life-threatening Respiratory Depression and Central Nervous System (CNS) Depression​

危及生命的呼吸抑制和中枢神经系统（CNS）抑郁的风险​

Buprenorphine has been associated with life-threatening respiratory depression and death. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants, including alcohol, while under treatment with buprenorphine and naloxone sublingual tablets. ​Use with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression).

丁丙诺啡与危及生命的呼吸抑制和死亡有关。警告患者服用丁丙诺啡和纳洛酮舌下片剂时自我服用苯二氮卓类药物或其他中枢神经系统抑制剂（包括酒精）的潜在危险。​呼吸功能受损（例如慢性阻塞性肺病，肺心病，呼吸储备减少，缺氧，高碳酸血症或预先存在的呼吸抑制）的患者应谨慎使用。

Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA), sleep-related hypoxemia..

阿片类药物可引起睡眠相关呼吸障碍，包括中枢性睡眠呼吸暂停（CSA），睡眠相关低氧血症。。

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose

患者获得纳洛酮用于阿片类药物过量的紧急治疗

Strongly consider prescribing naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with buprenorphine and naloxone sublingual tablets and consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose..

在开始和恢复丁丙诺啡和纳洛酮舌下片剂治疗时，强烈考虑开纳洛酮紧急治疗阿片类药物过量，如果患者有家庭成员（包括儿童）或其他有意外摄入或阿片类药物过量风险的密切接触者，则考虑开用纳洛酮。。

Advise patients and caregivers that naloxone may also be administered for a known or suspected overdose with buprenorphine and naloxone sublingual tablet itself. Educate patients and caregivers on how to recognize respiratory depression and, if naloxone is prescribed, how to treat with naloxone. Emphasize the importance of calling 911 or getting emergency medical help, even if naloxone is administered..

建议患者和护理人员，纳洛酮也可以用于已知或疑似过量的丁丙诺啡和纳洛酮舌下片剂本身。教育患者和护理人员如何识别呼吸抑制，如果服用纳洛酮，如何使用纳洛酮治疗。强调拨打911或获得紧急医疗帮助的重要性，即使服用纳洛酮。。

Managing Risks from Concomitant Use of Benzodiazepine or Other CNS Depressants

管理同时使用苯二氮卓类或其他中枢神经系统抑制剂的风险

Concomitant use of buprenorphine and benzodiazepines or other CNS depressants increases the risk of adverse reactions including overdose and death. Medication-assisted treatment of opioid use disorder, however, should not be categorically denied to patients taking these drugs. Prohibiting or creating barriers to treatment can pose an even greater risk of morbidity and mortality due to the opioid use disorder alone.

同时使用丁丙诺啡和苯二氮卓类药物或其他中枢神经系统抑制剂会增加不良反应的风险，包括过量服用和死亡。然而，服用这些药物的患者不应明确拒绝药物辅助治疗阿片类药物使用障碍。仅由于阿片类药物使用障碍，禁止或制造治疗障碍可能会带来更大的发病率和死亡率风险。

As a routine part of orientation to buprenorphine treatment, educate patients about the risks of concomitant use of benzodiazepines, sedatives, opioid analgesics, and alcohol..

作为丁丙诺啡治疗方向的常规部分，教育患者同时使用苯二氮卓类药物，镇静剂，阿片类镇痛药和酒精的风险。。

Unintentional Pediatric Exposure ​

儿童意外接触​

Buprenorphine can cause severe, possibly fatal, respiratory depression in children.​ Store buprenorphine and naloxone sublingual tablet safely out of the sight and reach of children.​

丁丙诺啡可导致儿童严重的，可能致命的呼吸抑制。​ 将丁丙诺啡和纳洛酮舌下片剂安全储存在儿童看不见和接触不到的地方。​

Neonatal Opioid Withdrawal Syndrome ​

新生儿阿片类药物戒断综合征​

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Advise pregnant women receiving opioid addiction treatment with buprenorphine and naloxone sublingual tablets of the risk of neonatal opioid withdrawal syndrome.

新生儿阿片类药物戒断综合征（NOWS）是怀孕期间长期使用阿片类药物的预期和可治疗的结果。建议接受丁丙诺啡和纳洛酮舌下含片阿片类药物成瘾治疗的孕妇有患新生儿阿片类药物戒断综合征的风险。

Adrenal Insufficiency​

肾上腺皮质功能不全​

If diagnosed with adrenal insufficiency treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ​

如果诊断为肾上腺皮质功能不全，则用生理替代皮质类固醇治疗，并使患者断奶服用阿片类药物。​

​Risk of Opioid Withdrawal with Abrupt Discontinuation​

​阿片类药物突然停药的风险​

If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately. ​

如果治疗暂时中断或停止，请监测患者是否停药并进行适当治疗。​

Risk of Hepatitis, Hepatic Events​

肝炎、肝脏事件的风险​

Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events. ​

在开始之前和治疗期间监测肝功能检查，并评估疑似肝事件。​

Hypersensitivity Reactions

超敏反应

Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. The most common signs and symptoms include rashes, hives, and pruritus.

已经报道了支气管痉挛，血管神经性水肿和过敏性休克的病例。最常见的体征和症状包括皮疹、荨麻疹和瘙痒症。

Precipitation of Opioid Withdrawal Signs and Symptoms​

阿片类药物戒断症状和体征的沉淀​

An opioid withdrawal syndrome is likely to occur with parenteral misuse of buprenorphine and naloxone sublingual tablet by individuals physically dependent on full opioid agonists, or by sublingual administration before the agonist effects of other opioids have subsided. ​

阿片类药物戒断综合征可能发生在身体上依赖完全阿片类药物激动剂的个体肠胃外滥用丁丙诺啡和纳洛酮舌下片剂，或者在其他阿片类药物的激动剂作用消退之前通过舌下给药。​

Risk of Overdose in Opioid-Naïve Patients​

未服用阿片类药物的患者服用过量的风险​

Buprenorphine and naloxone sublingual tablet is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublingual dose.

丁丙诺啡和纳洛酮舌下片剂不适合作为镇痛药。据报道，接受2毫克舌下剂量的阿片类药物初治者死亡。

Use in Patients with Impaired Hepatic Function

用于肝功能受损患者

Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. Use of buprenorphine/naloxone may result in an increased risk of precipitated withdrawal at the beginning of treatment (induction) and may interfere with buprenorphine's efficacy throughout treatment..

丁丙诺啡/纳洛酮产品不推荐用于严重肝功能损害患者，可能不适用于中度肝功能损害患者。使用丁丙诺啡/纳洛酮可能会导致治疗开始（诱导）时突然停药的风险增加，并可能在整个治疗过程中干扰丁丙诺啡的疗效。。

Dental Adverse Events

牙科不良事件

Cases of dental caries, some severe (i.e., tooth fracture, tooth loss), have been reported following the use of transmucosal buprenorphine-containing products. Educate patients to seek dental care and strategies to maintain or improve oral health while being treated with buprenorphine and naloxone sublingual tablets..

据报道，在使用含丁丙诺啡的透粘膜产品后，龋齿病例有些严重（即牙齿断裂，牙齿脱落）。教育患者在接受丁丙诺啡和纳洛酮舌下含片治疗时寻求牙科护理和维持或改善口腔健康的策略。。

QTc Prolongation

QTC扩展

Thorough QT studies with buprenorphine products have demonstrated QT prolongation ≤15 msec. The risk of combining buprenorphine with other QT prolonging agents is not known. Consider these observations in clinical decisions when prescribing buprenorphine and naloxone sublingual tablets to patients with QT-related risk factors..

丁丙诺啡产品的全面QT研究表明QT延长≤15毫秒。丁丙诺啡与其他QT延长剂联合使用的风险尚不清楚。当向QT相关危险因素患者开具丁丙诺啡和纳洛酮舌下片剂时，在临床决策中考虑这些观察结果。。

Impairment of Ability to Drive or Operate Machinery

驾驶或操作机器的能力受损

Caution patients that buprenorphine and naloxone sublingual tablets may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.

警告患者，丁丙诺啡和纳洛酮舌下片剂可能会损害执行潜在危险任务（如驾驶汽车或操作机器）所需的精神或身体能力。

Orthostatic Hypotension

体位性低血压

Like other opioids, buprenorphine and naloxone sublingual tablets may produce orthostatic hypotension in ambulatory patients.

与其他阿片类药物一样，丁丙诺啡和纳洛酮舌下片剂可能会在门诊患者中产生体位性低血压。

Elevation of Cerebrospinal Fluid Pressure

脑脊液压力升高

Buprenorphine, like other opioids, may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased. Buprenorphine can produce miosis and changes in the level of consciousness that may interfere with patient evaluation..

丁丙诺啡与其他阿片类药物一样，可能会升高脑脊液压力，对于头部受伤，颅内病变和其他脑脊液压力可能升高的情况，应谨慎使用。丁丙诺啡会引起瞳孔缩小和意识水平的变化，这可能会干扰患者的评估。。

Elevation of Intracholedochal Pressure

颅内压升高

Buprenorphine has been shown to increase intracholedochal pressure, as do other opioids, and thus should be administered with caution to patients with dysfunction of the biliary tract.

丁丙诺啡已被证明与其他阿片类药物一样可增加胆总管内压，因此应谨慎使用胆道功能障碍患者。

Effects in Acute Abdominal Conditions

对急腹症的影响

As with other opioids, buprenorphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

与其他阿片类药物一样，丁丙诺啡可能会掩盖急腹症患者的诊断或临床过程。

ADVERSE REACTIONS

不良反应

Adverse events commonly observed with buprenorphine and naloxone sublingual tablets include oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

丁丙诺啡和纳洛酮舌下片剂常见的不良事件包括口腔感觉减退，舌痛，口腔粘膜红斑，头痛，恶心，呕吐，多汗症，便秘，戒断症状和体征，失眠，疼痛和周围水肿。

DRUG INTERACTIONS

药物相互作用

Benzodiazepines or other Central Nervous System (CNS) Depressants: Use with caution in patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration and misuse.

苯二氮卓类或其他中枢神经系统（CNS）抑制剂：在接受苯二氮卓类或其他中枢神经系统抑制剂的患者中谨慎使用，并警告患者不要同时自我给药和滥用。

CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over- or under- dosing.

CYP3A4抑制剂和诱导剂：监测开始或结束CYP3A4抑制剂或诱导剂的患者是否可能过量或不足。

Antiretrovirals: Patients who are on chronic buprenorphine treatment should have their dose monitored if NNRTIs are added to their treatment regimen. Monitor patients taking buprenorphine and atazanavir with and without ritonavir, and reduce dose of buprenorphine if warranted.

抗逆转录病毒药物：接受慢性丁丙诺啡治疗的患者如果在治疗方案中加入NNRTI，应监测其剂量。监测服用丁丙诺啡和阿扎那韦（有或没有利托那韦）的患者，并在必要时减少丁丙诺啡的剂量。

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue buprenorphine and naloxone sublingual tablets if serotonin syndrome is suspected.

5-羟色胺能药物：同时使用可能导致5-羟色胺综合征。如果怀疑有血清素综合征，停止服用丁丙诺啡和纳洛酮舌下片。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Lactation: Buprenorphine passes into the mother’s milk. Advise breastfeeding women to monitor the infant for increased drowsiness and breathing difficulties.

哺乳期：丁丙诺啡进入母乳。建议母乳喂养的女性监测婴儿的嗜睡和呼吸困难。

Geriatric patients: Monitor geriatric patients for sedation and respiratory depression.

老年患者：监测老年患者的镇静和呼吸抑制。

Moderate and Severe Hepatic Impairment: Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

中度和重度肝功能损害：丁丙诺啡/纳洛酮产品不推荐用于严重肝功能损害患者，可能不适用于中度肝功能损害患者。

Please read Full Prescribing Information.

请阅读完整的处方信息。

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888 726-7535, option 2, or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

要报告可疑的不良反应，请联系Purdue Pharma L.P.，电话1-888 726-7535，选项2，或联系FDA，电话1-800-FDA-1088或www.FDA.gov/safety/medwatch。

Intended for healthcare professionals of the United States of America only.

仅适用于美国的医疗保健专业人员。

About Purdue Pharma L.P.

关于普渡制药有限公司。

Purdue Pharma and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. Purdue’s plan of reorganization will deliver billions in value to communities across the country to fund programs specifically for abatement of the opioid crisis.

普渡制药及其子公司开发、制造和销售药物，以满足医疗保健专业人员、患者和护理人员不断变化的需求。普渡大学的重组计划将为全国各地的社区带来数十亿美元的价值，为专门用于缓解阿片类药物危机的项目提供资金。

The bankruptcy settlement will also deliver funds to private abatement trusts for the benefit of personal injury claimants..

破产和解还将为个人伤害索赔人的利益向私人减排信托提供资金。。

Substantially all of Purdue’s assets will be transferred to a new post-emergence company with a public-minded mission. This new company will be governed by new independent board members and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis.

基本上，普渡大学的所有资产都将被转移到一家新的具有公众意识的公司。这家新公司将由新的独立董事会成员管理，并将以负责任和可持续的方式运作，同时考虑到与阿片类药物危机有关的长期公共卫生利益。

The company will continue serving patients who rely on its medicines, pursuing its pipeline and introducing medicines that will help save and improve lives..

该公司将继续为依赖其药物的患者提供服务，继续开发其管道，并推出有助于挽救和改善生命的药物。。

For more information, visit www.purduepharma.com.

For more information, visit www.purduepharma.com.

References:

参考文献：

The White House, Executive Office of the President, Office of National Drug Control Policy (ONDCP). National Drug Control Strategy. https://www.whitehouse.gov/wp-content/uploads/2022/04/National-Drug-Control-2022Strategy.pdf

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