[{"orgOrder":0,"company":"Avenue Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Avenue Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avenue Therapeutics Announces Presentation of IV Tramadol E-Posters","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Avenue 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Pharmaceutical","sponsor":"Kowa Pharmaceuticals America","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Esteve and Kowa Pharmaceuticals America Enter into an Exclusive License and Commercialization Agreement for Rights to E-58425","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Avenue Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avenue Therapeutics Provides Regulatory Update for IV Tramadol","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Avenue 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Announces Publication of Phase 3 Data Supporting FDA Approval of SEGLENTIS\u00ae(celecoxib 56-mg and tramadol hydrochloride 44mg)CI-V as an Efficacious Alternative for Moderate-to-Severe Acute Pain in Appropriate Patients","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Avenue Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Avenue Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avenue Therapeutics Announces Agreement with the FDA on the Study Design and Analysis Approach of the Phase 3 Safety Study for IV Tramadol","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Avenue Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avenue Therapeutics Reaches Final Agreement with the U.S. FDA for the Phase 3 Safety Study for IV Tramadol","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for (+)-Tramadol Hydrochloride
AVE-901 (tramadol) inhibits serotonin reuptake and norepinephrine reuptake, enhancing inhibitory effects on pain transmission in the spinal cord. It is being developed for the treatment of post-operative pain.
AVE-901 (tramadol) inhibits serotonin reuptake and norepinephrine reuptake, enhancing inhibitory effects on pain transmission in the spinal cord. It is being developed for the treatment of post-operative pain.
AVE-901 (tramadol) inhibits serotonin reuptake and norepinephrine reuptake, enhancing inhibitory effects on pain transmission in the spinal cord. It is being developed for the treatment of post-operative pain.
Avenue expects to use the net proceeds from the offering, for general corporate purposes and working capital, including the development of its drug product candidates including AVE-901 (tramadol).
Avenue expects to use the net proceeds to repurchase all of the shares of its common stock held by InvaGen Pharmaceuticals Inc., to be used for general corporate purposes and working capital, including the progression of IV Tramadol (AVE-901) and the development of BAER-101.
Avenue expects to use the net proceeds from the offering, for general corporate purposes and working capital, including the development of its drug product candidates including AVE-901 (tramadol).
The primary efficacy endpoint met and studied was summed pain intensity difference from 0 to 48 hours (SPID0-48). SEGLENTIS (celecoxib) had a significantly greater effect on SPID0-48 (least-squares mean: −139.1 than tramadol, celecoxib or placebo.
Under the terms of the agreements, ESTEVE has granted KPA exclusive rights to commercialize E-58425 in the United States. E-58425 is a new product comprised of a co-crystal form of celecoxib and tramadol for the management of acute pain in adults.
Avenue intends to resubmit the NDA in February 2021, barring any Covid-19 related or other setbacks. The NDA resubmission will incorporate revised language relating to the proposed product label and a report relating to terminal sterilization validation.
The CRL stated that IV tramadol, to treat patients in acute pain who require an opioid, is not safe for the intended patient population. If a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic would be needed.
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