Avenue Therapeutics Submits New Drug Application for IV Tramadol

Avenue Therapeutics用于治疗中度至重度疼痛的静脉曲马多新药向FDA提交申请

2019-12-12 16:32:26 Investing News Network


The company submitted a new drug application to the US Food and Drug Administration for its treatment IV tramadol. Avenue Therapeutics (NASDAQ:ATXI) has announced it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for IV tramadol to manage moderate to moderately severe pain in adults in a supervised healthcare scenario. As quoted in the press release: The NDA for IV tramadol is based on positive results from two pivotal Phase 3 clinical efficacy and safety trials in patients following bunionectomy and abdominoplasty surgeries, as well as an open-label safety study with a total of more than 500 patients who received the IV tramadol 50 mg dosing regimen.  In addition, the NDA includes an epidemiology study on abuse of tramadol in the U.S. and in certain European countries where IV tramadol is available. The study finds that reports of abuse with tramadol are infrequent, both in absolute number and relative to other prescription opioids, and that abuse of tramadol via injection is uncommon relative to oral tramadol in countries where it is available. “As a potential alternative that could reduce the use of conventional opioids, IV tramadol may fill a gap between IV acetaminophen/NSAIDs and IV conventional narcotics in the acute pain space,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “The submission of this NDA is an important milestone for our company, and we look forward to working closely with the FDA during the review process.”
公司向美国食品药品监督管理局提交了治疗 IV 型曲马多的新药申请。 Avenue Therapeutics ( NASDAQ : ATXI )宣布已向美国食品和药物管理局( FDA )提交了一份新药申请( NDA ),申请 IV 曲马多,以管理成年人中中度至中度重度疼痛的监督医疗方案。 如新闻稿所述: 静脉曲马多的 NDA 是基于两个关键的3期临床疗效和安全性试验的积极结果,在病人进行输精管切除和腹部成形术,以及一个开放标签的安全研究,共有超过500名患者接受静脉曲马多50毫克剂量养生法。此外, NDA 还包括一项关于美国和某些欧洲国家有四型电车滥用情况的流行病学研究。研究发现,无论是绝对数量还是相对于其他处方类阿片类药物而言,曲马多滥用的报告都不多见,而且在有口服曲马多的国家,通过注射曲马多滥用的情况也不常见。 “作为一种可能减少常规阿片类药物使用的潜在替代品,静脉曲马多可能填补静脉乙酰氨基酚/ NSAIDs 与静脉常规麻醉剂在急性疼痛领域的空白,” Avenue 总裁兼首席执行官 Lucy Lu 表示。“提交这份 NDA 是我们公司的一个重要里程碑,我们期待在审查过程中与 FDA 密切合作。”