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Stimulants are typically the go-to option for doctors prescribing treatments for attention-deficit hyperactivity disorder (ADHD). But some ADHD patients do not respond adequately to stimulants or have difficulty with their side effects.Providing a new alternative is Tris Pharma, which has won FDA approval for Onyda XR (clonidine hydrochloride).
兴奋剂通常是医生处方治疗注意力缺陷多动障碍(ADHD)的首选药物。但是,一些多动症患者对兴奋剂反应不足,或者对其副作用有困难。Tris Pharma提供了一种新的替代品,它已获得FDA对Onyda XR(盐酸可乐定)的批准。
The extended-release oral suspension becomes the first liquid non-stimulant medication for ADHD and the only non-stimulant with nighttime dosing in the indication.Onyda XR can be used as a monotherapy or in combination with central nervous system stimulants in pediatric patients ages 6 and older. Tris expects Onyda XR to be available in the second half of this year.Through a company spkesperson, CEO and founder Ketan Mehta said that Tris anticipates 'having pricing details available' as the launch approaches.Onyda XR adds to the portfolio of ADHD medications offered by the 24-year-old, privately-owned New Jersey drugmaker which develops and manufactures specialty generics along with branded and over-the-counter products.RelatedTris Pharma, a CMO for Pfizer, hit with FDA warning letter for ADHD drug, morphine solutionTris sells ADHD medications in liquid and tablet form for both adults and children.
缓释口服混悬液成为第一种用于多动症的液体非兴奋剂药物,也是唯一一种夜间给药的非兴奋剂药物。Onyda XR可用作6岁及以上儿科患者的单一疗法或与中枢神经系统兴奋剂联合使用。Tris预计Onyda XR将于今年下半年上市。首席执行官兼创始人科坦·梅塔(KetanMehta)通过一位公司间谍表示,Tris预计随着上市的临近,“将有定价细节”。Onyda XR增加了这家24岁的私人新泽西制药商提供的ADHD药物组合,该制药商开发和生产特殊仿制药以及品牌和非处方产品。辉瑞公司的首席营销官RelatedTris Pharma收到FDA关于ADHD药物的警告信,吗啡溶液Tris为成人和儿童销售液体和片剂形式的ADHD药物。
All were developed with the company’s LiquiXR drug delivery technology, which allows immediate-release products to be transformed into those with extended-release characteristics, providing for once-daily dosing.The platform facilitated the development of Onyda XR from an older compound. The FDA signed off on clonidine pills to treat high blood pressure 50 years ago.
所有这些都是使用该公司的LiquiXR药物输送技术开发的,该技术允许立即释放的产品转化为具有缓释特性的产品,提供每日一次的剂量。该平台促进了从旧化合物开发Onyda XR。50年前,FDA签署了可乐定治疗高血压的药丸。
In addition, Viatris markets Duraclon, an injected formulation of clonidine used in combination with opiates for severe pain in cancer patients.RelatedTexas accuses Pfizer.
此外,Viatris还销售Duraclon,一种可乐定注射制剂,与阿片类药物联合用于治疗癌症患者的严重疼痛。德克萨斯州相关部门指控辉瑞公司。