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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.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2024
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.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2023
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.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 17, 2023
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).
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aegis Capital Corp.
Deal Size: $12.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 11, 2022
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 development of BAER-101.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aegis Capital Corp.
Deal Size: $13.8 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 06, 2022
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).
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aegis Capital Corp.
Deal Size: $12.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 06, 2022
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.
Lead Product(s): Celecoxib,Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: Seglentis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
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.
Lead Product(s): Celecoxib,Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: E-58425
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kowa Pharmaceuticals America
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 03, 2021
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.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2020
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 analgesic would be needed.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
USFDA has approved QDOLO™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: Qdolo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
The objective of this Phase 3 study was to compare the analgesic benefit and tolerability of two doses of IV tramadol to placebo in adult patients undergoing bunionectomy, an orthopedic surgical model. Eligible patients were randomized to IV tramadol 50 mg, 25 mg or placebo.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2020
Details:
The results of the study demonstrated that IV tramadol was statistically superior to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020
Details:
Company to present e-posters highlighting efficacy and safety results from its Phase 3 program at Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the ASRA.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2020
Details:
FDA has accepted for review Avenue’s NDA for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.
Lead Product(s): Tramadol Hydrochloride
Therapeutic Area: Neurology Product Name: AVE-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2020
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