Indivior PLC  announced that the FDA has approved label changes for Sublocade (buprenorphine extended-release ) including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder (OUD)

Indivior PLC 宣布，FDA 已批准 Sublocade（丁丙诺啡缓释剂）的标签变更，包括快速启动方案和替代注射部位，这标志着中重度阿片类药物使用障碍（OUD）治疗的重大进展。

Key Label Changes Include:

关键标签更改包括：

Rapid initiation Protocol: Healthcare providers can now initiate treatment with Sublocade after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.

快速启动方案：医疗保健提供者现在可以在单剂量的经粘膜丁丙诺啡和一小时的观察期以确认耐受性后，启动Sublocade治疗。

Alternative Injection Sites: Sublocade can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration.

替代注射部位：Sublocade现在可以皮下注射在腹部、大腿、臀部或上臂后部，为患者和医疗保健提供者在治疗管理上提供了更大的灵活性。

These FDA label changes can provide important benefits for patients and healthcare providers. Rapid initiation may lessen some of the practical obstacles to treatment induction, which may increase the likelihood that patients and providers will start therapy quickly, thereby shortening the time to achieve Sublocade’s therapeutic levels that provide continuous buprenorphine concentrations above 2ng/mL.

这些FDA标签变更可以为患者和医疗保健提供者带来重要益处。快速启动可能会减少治疗开始的一些实际障碍，这可能会增加患者和提供者快速开始治疗的可能性，从而缩短达到Sublocade治疗水平的时间，该水平可提供高于2ng/mL的持续丁丙诺啡浓度。

Additionally, the ability to select a different injection site may provide patients more flexibility so that they may be inclined to continue their treatment. More options for healthcare providers to administer Sublocade  will streamline the course of treatment and improve integration into different healthcare environments..

此外，选择不同注射部位的能力可能会为患者提供更大的灵活性，使他们更倾向于继续治疗。医疗保健提供者在施用Sublocade时有更多选择，这将简化治疗过程，并改善其在不同医疗环境中的整合。

Indivior is committed to empowering patients on their path to recovery by providing treatments that are both effective and tailored to their medical needs. These label changes do not alter the well-established safety profile or the efficacy of Sublocade  and the medication continues to offer an effective treatment option for OUD while being more adaptable to patient medical needs..

Indivior致力于通过提供既有效又符合患者医疗需求的治疗方案，助力患者踏上康复之路。这些标签变更并未改变Sublocade久经验证的安全性或有效性，该药物仍然是治疗阿片类药物使用障碍（OUD）的有效选择，同时更加适应患者的医疗需求。

The non-inferiority study supporting rapid induction with Sublocade was conducted across multiple sites, included 729 participants (mean age 40.7, average opioid use of 15 years), and was stratified by fentanyl presence in urine screens. At induction 77.5% of patients were fentanyl-positive. Patients were randomized at a 2:1 ratio to rapid initiation [received a single dose of 4 mg transmucosal buprenorphine (TM-BUP), followed by a Sublocade   injection within one hour] or to a standard induction (daily TM-BUP over ≥7 days) before receiving injection .

支持Sublocade快速诱导的非劣效性研究在多个地点进行，包括729名参与者（平均年龄40.7岁，平均使用阿片类药物15年），并根据尿液筛查中是否存在芬太尼进行了分层。在诱导时，77.5%的患者为芬太尼阳性。患者以2:1的比例随机分配至快速启动组[接受单剂4毫克经粘膜丁丙诺啡（TM-BUP），随后在一小时内注射Sublocade]或标准诱导组（连续≥7天每日服用TM-BUP），之后再接受注射。

Rapid induction was effective, shown by the primary endpoint of participant retention at the second injection. The proportion of participants who received the second injection was 66.4% in the rapid induction arm and 54.5% in the standard induction arm..

快速诱导效果显著，这通过参与者在第二次注射时的保留率这一主要终点得到了证明。在快速诱导组中，接受第二次注射的参与者比例为66.4%，而在标准诱导组中，这一比例为54.5%。

Condition:

条件：

Opioid Dependence/Overdose

阿片类药物依赖/过量

Type:

类型：

drug

药物