Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Avenue Therapeutics Finalizes Agreement with FDA for IV Tramadol Phase 3 Safety Study
Details : AVE-901 (tramadol) inhibits serotonin reuptake and norepinephrine reuptake, enhancing inhibitory effects on pain transmission in the spinal cord. It is being developed for post-operative pain.
Brand Name : AVE-901
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 04, 2024
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : AVE-901
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 25, 2023
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : AVE-901
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 17, 2023
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Aegis Capital Corp.
Deal Size : $12.0 million
Deal Type : Public Offering
Avenue Therapeutics Announces Closing of $12 Million Underwritten Public Offering
Details : 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).
Brand Name : AVE-901
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 11, 2022
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Aegis Capital Corp.
Deal Size : $12.0 million
Deal Type : Public Offering
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Aegis Capital Corp.
Deal Size : $13.8 million
Deal Type : Public Offering
Avenue Therapeutics Announces Pricing of $12 Million Underwritten Public Offering
Details : 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 dev...
Brand Name : AVE-901
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 06, 2022
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Aegis Capital Corp.
Deal Size : $13.8 million
Deal Type : Public Offering
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Aegis Capital Corp.
Deal Size : $12.0 million
Deal Type : Public Offering
Avenue Therapeutics Announces Pricing of $12 Million Underwritten Public Offering
Details : 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).
Brand Name : AVE-901
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 06, 2022
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Aegis Capital Corp.
Deal Size : $12.0 million
Deal Type : Public Offering
Lead Product(s) : Celecoxib,Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : Seglentis
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 19, 2022
Lead Product(s) : Celecoxib,Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Celecoxib,Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Kowa Pharmaceuticals America
Deal Size : Undisclosed
Deal Type : Agreement
Details : 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.
Brand Name : E-58425
Molecule Type : Small molecule
Upfront Cash : Undisclosed
May 03, 2021
Lead Product(s) : Celecoxib,Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Kowa Pharmaceuticals America
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Avenue Therapeutics Provides Regulatory Update for IV Tramadol
Details : 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.
Brand Name : AVE-901
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 17, 2020
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Avenue Therapeutics Receives Complete Response Letter from USFDA for IV Tramadol
Details : 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 analges...
Brand Name : AVE-901
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 12, 2020
Lead Product(s) : Tramadol Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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