MONTREAL, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ('Knight'), a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has entered into an exclusive license agreement with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) ('Supernus'), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, granting Knight the rights to seek regulatory approval and commercialize Qelbree® in Canada.

蒙特利尔，2023年12月19日（环球通讯社）--泛美（前美国）专业制药公司Knight Therapeutics Inc.（TSX:GUD）（“Knight”）今天宣布，它已与Supernus Pharmaceuticals，Inc.（纳斯达克：SUPN）（“Supernus”）签订独家许可协议，一家生物制药公司专注于开发和商业化用于治疗中枢神经系统（CNS）疾病的产品，授予Knight在加拿大寻求监管批准和商业化Qelbree®的权利。

Qelbree® is an extended-release formulation of viloxazine, a multimodal serotonergic and norepinephrine modulating agent (SNMA), a nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Financial terms of the agreement were not disclosed. Qelbree® (viloxazine extended-release capsules) is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older.

Qelbree®是维洛嗪的缓释制剂，维洛嗪是一种多模式5-羟色胺能和去甲肾上腺素调节剂（SNMA），是一种用于治疗注意力缺陷多动障碍（ADHD）的非刺激性药物。协议的财务条款没有披露。Qelbree®（维洛嗪缓释胶囊）在美国上市，作为治疗6岁及以上ADHD患者的处方药。

Based on the results of 4 pivotal trials,1-4 Qelbree® was approved by the US Food and Drug Administration in 2021 for the treatment of children 6-17 years of age and in 2022 for the treatment of adults. Qelbree® is also currently being studied in several phase 4 clinical trials5, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 20236).

根据4项关键试验的结果，美国食品和药物管理局于2021年批准1-4 Qelbree®用于治疗6-17岁儿童，并于2022年批准用于治疗成人。Qelbree®目前也正在进行几项4期临床试验5的研究，其中第一项试验与精神兴奋剂联合用于治疗儿童和青少年多动症（20236年9月报告的正面结果）。

A second phase 4 clinical trial7 in preschool age children with ADHD is planned to commence in January 2024. A third phase 4 clinical trial9 is studying the impact of Qelbree® on co-morbid mood symptoms prevalent in patients with ADHD. “This partnership represents the continued execution of our strategy of expanding our presence in CNS and entering in one of the most impor.

计划于2024年1月开始针对学龄前多动症儿童的第二阶段4临床试验7。第三阶段4临床试验9正在研究Qelbree®对ADHD患者常见的合并症情绪症状的影响。“这种合作关系代表着我们继续执行扩大在CNS的存在并进入最重要的战略之一的战略。