Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced that its Phase 1 data on intravenous tramadol has been published in the peer-reviewed journal Clinical Pharmacology in Drug Development.
NEW YORK, Oct. 28, 2019 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, announced today that its Phase 1 data on intravenous (IV) tramadol has been published in the peer-reviewed journal Clinical Pharmacology in Drug Development. Based on the results of the study, Avenue chose the IV tramadol 50 mg dosing regimen for Phase 3 development.
The objective of this Phase 1, open-label, single investigational center, three-treatment, three-period, multidose crossover study was to compare the pharmacokinetics of two novel IV tramadol dosing regimens to oral tramadol 100 mg given every six hours, the highest approved oral dosage in the United States. Compared to the oral regimen, IV tramadol 50 mg administered at hours 0, 2, and 4 and every 4 hours thereafter reached initial tramadol peak serum concentration (Cmax) more rapidly, while resulting in similar overall steady-state Cmax and area under the plasma concentration–time curve, and that the primary metabolite, M1, had lower area under the plasma concentration–time curve and Cmax than for the oral regimen. The IV tramadol 50 mg dosing regimen was well tolerated, with adverse event profiles consistent with the known pharmacological effects of tramadol.
The paper titled “Comparing the Pharmacokinetics of 2 Novel Intravenous Tramadol Dosing Regimens to Oral Tramadol: A Randomized 3-Arm Crossover Study”, can be accessed here.
About Avenue Therapeutics
Avenue is a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol for the management of moderate to moderately severe postoperative pain. IV tramadol may fill a gap in the acute pain market between IV acetaminophen/NSAIDs and IV conventional narcotics. Avenue has completed its Phase 3 program of IV tramadol for the management of postoperative pain and plans to submit a New Drug Application to the U.S. Food and Drug Administration by year-end. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.
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Contacts:
Jaclyn Jaffe and William Begien
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com
