NEW YORK, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that a publication entitled “IV tramadol: A novel option for US patients with acute pain—A review of its pharmacokinetics, abuse potential and clinical safety record” has been published in the peer-reviewed journal, Journal of Opioid Management, and can be accessed here.
This paper provides a review of the pharmacokinetics (“PK”) of the IV tramadol dosing regimen intended for the U.S., its abuse potential as documented in the literature, its safety record in clinical practice outside the U.S. and discusses how IV tramadol may become a useful option for patients with acute pain in the U.S. The review includes the following:
The PK profile of the IV tramadol dosing regimen, which results in similar overall steady‐state Cmax (peak serum concentration) and AUC (Area Under the Curve) for tramadol, and a lower Cmax, AUC, as well as slower onset of M1 (tramadol’s primary metabolite and a more potent µ agonist than the parent compound), as compared to oral tramadol 100 mg administered once every 6 hours.
A focused and targeted review of the literature regarding tramadol abuse in the U.S. where oral tramadol is available and in countries where oral and IV tramadol are approved. It found that the abuse potential for IV tramadol is highly likely to be even lower than that of oral tramadol and much lower than other opioids, and that the abuse potential for oral tramadol is low in comparison to more potent opioids such as morphine, oxycodone, and hydrocodone.
An examination of the most frequently reported adverse events (“AEs”) associated with IV tramadol use in the VigiBase, the WHO global database of Individual Case Safety Reports. Despite the potential limitations of this spontaneous reporting database, IV tramadol in general appears to be comparable to oral tramadol with respect to AE reports in all regions.
The paper concluded that the availability of IV tramadol as an alternative to pure µ opioid analgesics should be a valuable option for U.S. clinicians who treat acute pain in the hospital setting.
About Avenue Therapeutics
Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. 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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Jaclyn Jaffe and William Begien
Avenue Therapeutics, Inc.