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Find Clinical Drug Pipeline Developments & Deals for (+)-Tramadol Hydrochloride
TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;37.5MG, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG
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.