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MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12.
MONMOUTH JUNCTION,N.J.-(BUSINESS WIRE)-Tris Pharma,Inc。(Tris)是一家专注于ADHD,疼痛,成瘾和神经系统疾病的商业阶段生物制药公司,今天宣布加拿大卫生部已授权使用Quillivant®ER(延长释放)治疗6至12岁儿童的注意力缺陷多动障碍(ADHD)。
Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada..
Quillivant ER将作为口服混悬液和咀嚼片提供(在美国分别称为QuillivantXR®和QuillichewER®)。Quillivant ER是加拿大首个被批准用于治疗ADHD的每日一次,长效,咀嚼和口服哌醋甲酯悬浮制剂。。
“Children with ADHD around the world need medications that provide fast-acting and long-lasting relief in a range of formulations that are easy for them to take. Since the launch of our Quillivant XR product in the United States, we have been approached by potential partners to make our portfolio of ADHD products available around the world,” said Ketan Mehta, founder and chief executive officer at Tris Pharma.
“世界各地患有多动症的儿童需要药物,这些药物可以在一系列易于服用的配方中提供速效和持久的缓解。自我们的Quillivant XR产品在美国推出以来,我们一直与潜在的合作伙伴,使我们的多动症产品组合在世界各地可用,”Keton Mehta说,Tris Pharma的创始人兼首席执行官。
“We are truly delighted by this milestone, which will make this important medication available to millions of patients in Canada.”.
“我们真的很高兴这个里程碑,这将使加拿大数百万患者可以使用这种重要的药物。”。
Ontario-based KYE Pharmaceuticals, Inc. will make Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets available to patients in Canada beginning in Q1 2024. Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients.
位于安大略省的KYE Pharmaceuticals,Inc。将于2024年1月开始向加拿大患者提供Quillivant ER口服混悬液和Quillivant ER咀嚼片。Tris将在美国制造Quillivant ER,并向加拿大患者出口到KYE Pharmaceuticals。
ADHD is one of the most common neurodevelopmental disorders diagnosed among children. Many therapies approved to treat ADHD have well-established and significant drawbacks, including early symptom rebound, limited duration of release and efficacy, delayed onset, inability to customize or control titration, and patient difficulty taking the medications (e.g., children unable to swallow a tablet)..
ADHD是儿童中诊断出的最常见的神经发育障碍之一。许多批准用于治疗ADHD的疗法具有公认的和显著的缺点,包括早期症状反弹、释放和疗效的持续时间有限、起效延迟、无法定制或控制滴定、以及患者服用药物的困难(例如,儿童不能吞咽片剂)。)。。
In Canada, Quillivant ER is authorized for administration to children aged 6 to 12 diagnosed with ADHD as a once-daily liquid suspension or as a chewable tablet to overcome the difficulty of swallowing pills while still achieving the duration needed to control ADHD symptoms for the desired timeframe.
在加拿大,Quillivant ER被授权用于6至12岁被诊断患有ADHD的儿童,作为每日一次的液体悬浮液或咀嚼片剂,以克服吞咽药丸的困难,同时仍达到控制ADHD症状所需的持续时间。时间范围。
Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant ER Oral Suspension allows for personalized dosing with ease of titration and the Quillivant ER chewable tablets are scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet.
Quillivant ER在给药后45分钟至12小时内已显示出起效,全天提供一致,连续的分娩。Quillivant ER口服混悬液允许个性化给药,易于滴定,Quillivant ER咀嚼片是评分片,非常适合儿科患者,提供额外的剂量给药灵活性,延长释放哌醋甲酯片剂中提供最多剂量选择。
Tris developed both formulations using the company’s proprietary LiquiXR® technology..
Tris使用公司专有的LiquiXR®技术开发了两种配方。。
“Quillivant ER has the potential to address a significant unmet market need in the treatment of ADHD by overcoming drawbacks associated with many other ADHD medications, particularly among children,” said John McKendry, president at KYE Pharmaceuticals. “Our strategic partnership with Tris allows us to apply our extensive regulatory and commercial expertise to ensure this unique ADHD medication is made available to patients in Canada.”.
KYE Pharmaceuticals总裁John McKendry说:“Quillivant ER有可能通过克服与许多其他ADHD药物相关的缺点,特别是在儿童中,解决ADHD治疗中未满足的重大市场需求。“我们与Tris的战略合作关系使我们能够应用我们广泛的监管和商业专业知识,以确保这种独特的ADHD药物可供加拿大患者使用。”。
About Tris Pharma
关于Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates.
Tris Pharma是一家私营的,创新驱动的生物制药公司,正在应用其药物开发能力和专有技术来改变ADHD,疼痛和神经系统疾病的治疗方法,包括成瘾和中枢神经系统疾病。Tris是一家成熟的商业组织,拥有一流的ADHD产品组合和有前途的差异化近期候选药物管道。
More information is available at www.trispharma.com and on LinkedIn @TrisPharma..
更多信息请访问www.trispharma.com和LinkedIn@trispharma。。
About KYE Pharmaceuticals
关于KYE制药
Kye Pharmaceuticals Inc. is a private company headquartered in Mississauga, Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team’s strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, patients across Canada.
Kye Pharmaceuticals Inc.是一家总部设在加拿大密西沙加的私营公司,致力于将药物推向加拿大市场,以满足临床上重要且未满足的需求。KYE已经获得了许多创新产品的许可,其基础是创业精神,优化了我们团队的优势,为我们的合作伙伴,加拿大医疗保健专业人员以及最重要的加拿大患者带来了独特的价值。
For more information, please visit www.kyepharma.com..
欲了解更多信息,请访问www.kyepharma.com。。