The FDA on Wednesday signed off on Tris Pharma’s reformulation of clonidine hydrochloride for the treatment of attention deficit hyperactivity disorder in pediatric patients aged six years and older. The once-daily drug will be marketed under the brand name Onyda XR.

FDA于周三签署了Tris Pharma重新配制的盐酸可乐定，用于治疗6岁及以上儿科患者的注意力缺陷多动障碍。这种每日一次的药物将以品牌名Onyda XR销售。

Onyda XR is the first FDA-approved non-stimulant medication for attention deficit hyperactivity disorder (ADHD) with a liquid formulation and nighttime dosing, according to Tris. The biotech aims to make Onyda XR available in U.S. pharmacies by the second half of 2024.

据Tris称，Onyda XR是FDA批准的第一种用于治疗注意力缺陷多动障碍（ADHD）的非兴奋剂药物，具有液体配方和夜间剂量。该生物技术公司的目标是在2024年下半年之前使Onyda XR在美国药店上市。

Ketan Mehta, founder and CEO of Tris Pharma, in a statement called Wednesday’s approval an “important milestone” that can provide a new therapeutic option that improve treatment outcomes for patients. “We look forward to continuing to expand our portfolio in other ADHD indications.”

Tris Pharma创始人兼首席执行官科坦·梅塔（KetanMehta）在一份声明中称，周三的批准是一个“重要的里程碑”，可以提供一种新的治疗选择，改善患者的治疗效果。“我们期待着继续扩大我们在其他ADHD适应症方面的投资组合。”

Clonidine is a well-established pharmaceutical compound that first won the FDA’s approval in 1974 for the treatment of high blood pressure. According to Onyda XR’s label, it works by stimulating alpha 2-adrenergic receptors in the brain, though its exact mechanism of action in ADHD is still unknown.

可乐定是一种成熟的药物化合物，1974年首次获得FDA批准用于治疗高血压。根据Onyda XR的标签，它通过刺激大脑中的α2-肾上腺素能受体起作用，尽管其在ADHD中的确切作用机制尚不清楚。

Clonidine is not a stimulant of the central nervous system..

可乐定不是中枢神经系统的兴奋剂。。

In ADHD, Clonidine was approved in 2010 under the brand name Kapvay, which is owned by Shionogi. Kapvay is indicated for children and adolescents aged six to 17 years of age and can be given alone or on top of stimulant medication.

在多动症中，可乐定于2010年以Shionogi拥有的品牌Kapvay获得批准。Kapvay适用于6至17岁的儿童和青少年，可以单独服用或在兴奋剂药物的基础上服用。

Onyda XR was developed using Tris’ LiquiXR platform, producing a “smooth, extended-release profile,” according to the company. Its approval was supported by well-controlled studies of the extended-release medication.

据该公司称，Onyda XR是使用Tris'LiquiXR平台开发的，产生了“平滑的，扩展的发布配置文件”。它的批准得到了对缓释药物的良好控制研究的支持。

With Wednesday’s approval, Onyda XR will help address a substantial and growing gap in the ADHD market, which is currently suffering from a protracted and record-breaking shortage of medicines due to continuing global supply chain problems and manufacturing quality issues.

在周三的批准下，Onyda XR将帮助解决ADHD市场上巨大且不断扩大的差距，由于全球供应链问题和制造质量问题的持续存在，ADHD市场目前面临长期且创纪录的药品短缺。

The patent expiration for Takeda’s oral amphetamine Vyvanse (lisdexamfetamine dimesylate)—a top-seller in the ADHD market, bringing in $2.52 billion between March 2021 and 2022—will also open up the space for generics that could help alleviate the shortage.

武田的口服安非他明Vyvanse（lisdexamfetamine dimesylate）是多动症市场上最畅销的药物，其专利到期后将在2021年3月至2022年期间带来25.2亿美元的收入，这也将为仿制药开辟空间，有助于缓解短缺。