Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA

Avenue Therapeutics 公布 IV Tramadol 新药申请获 FDA 批准

2020-02-14 05:00:09 BioSpace


NEW YORK, Feb. 13, 2020 -- Avenue Therapeutics, Inc. , a company focused on the development of intravenous tramadol for the U.S. market, today announced that the U.S. Food and Drug Administration has accepted for review Avenue’s New Drug Application for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting. The FDA set a Prescription Drug User Fee Act goal action date of October 10, 2020. “The NDA submission acceptance is another important step toward bringing IV tramadol to patients and their healthcare providers in the U.S.,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “We look forward to working with the FDA as they evaluate our application.” About Avenue Therapeutics Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.   Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Contacts: Jaclyn Jaffe and William Begien Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com
纽约,2020年2月13日-- Avenue Therapeutics , Inc .,一家专注于为美国市场开发静脉曲马多的公司,今天宣布,美国食品药品监督管理局(Food and Drug Administration)已接受审查道的新药申请 IV 曲马多用于管理中度至中度严重疼痛成年人在一个医疗监督的医疗保健环境。FDA 设定了处方药使用者费用法案的目标行动日期为2020年10月10日。 “ NDA 的接受是将 IV 曲马多引入美国患者及其医疗保健提供者的另一个重要步骤,” Avenue 总裁兼首席执行官 Lucy Lu 说。“我们期待着与 FDA 合作,评估我们的申请。” 关于 Avenue Therapeutics Avenue Therapeutics 是一家专业制药公司,其使命是开发 IV tramutral ,一种可能减少常规阿片类药物的使用,为患有急性疼痛的患者在美国大道总部设在纽约市,由 Fortress Biotech , Inc .( NASDAQ : FBIO )创立。有关详细信息,请访问 www.avenutx.com 。 前瞻性陈述 本新闻稿可能包含《1933年证券法》第27A 条和《1934年证券交易法》第21E 条含义内的“前瞻性陈述”,每一条都经过修订。此类声明包括但不限于与我们的增长战略和产品开发计划有关的任何声明,以及不属于历史事实的任何其他声明。前瞻性陈述基于管理层目前的预期,并受可能对我们的业务、经营业绩、财务状况和股票价值产生负面影响的风险和不确定性影响。可能导致实际结果与当前预期结果存在重大差异的因素包括:与我们从 FDA 获得产品候选者的监管批准有关的风险。与我们的增长战略有关的风险;与研发活动结果有关的风险;与开始和完成临床试验的时间安排有关的风险;我们获得、执行和维护融资和战略协议及关系的能力;与临床前和临床试验有关的不确定性;我们对第三方供应商的依赖;我们吸引的能力整合和留住关键人员;产品开发的早期阶段;我们需要大量额外资金;政府监管;专利和知识产权事务;竞争;以及我们向 SEC 提交的文件中描述的其他风险。除法律要求外,我们明确声明不承担任何义务或承诺公开发布本协议所载任何前瞻性声明的任何更新或修订,以反映我们预期的任何变化或任何此类声明所依据的事件、条件或情况的任何变化。 联系人: Jacklyn Jaffe 和 William Behash Avenue Therapeutics , Inc .。 (781)652-4500 ir @ avenuetx.com