Avenue Therapeutics Announces Dosing of First Patient in Phase III Safety Trial of Intravenous Tramadol for the Management of Postoperative Pain
NEW YORK, Jan. 02, 2018 (GLOBE NEWSWIRE) -- Avenue Therapeutics (NASDAQ:ATXI) (“Avenue”), a company focused on the development and commercialization of intravenous (IV) tramadol, today announced that it has dosed the first patient in its Phase 3 safety trial of IV tramadol for the management of moderate to moderately severe pain.
“We are pleased to announce the dosing of the first patient in our Phase 3 safety trial of IV tramadol. This safety study is a key component of our pivotal Phase 3 development program and will be used to support our planned new drug application (NDA), which we hope to submit to the U.S. Food and Drug Administration in late 2019,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “We believe that IV tramadol, which has been used widely outside the U.S., has the potential to fill the gap between IV acetaminophen/NSAIDs and conventional IV narcotics, and may help circumvent the use of conventional narcotics. We look forward to rapidly advancing our pivotal program, which will bring us closer to our goal of making available the first Schedule IV intravenous opioid in the U.S.”
The Phase 3, multicenter, open-label trial will evaluate the safety of IV tramadol 50 mg in the management of postoperative pain following surgery. The trial will enroll approximately 250 patients to receive 50 mg of IV tramadol over 15 minutes at zero, two and four hours, then once every four hours thereafter.
Avenue Therapeutics is currently evaluating IV tramadol in a Phase 3 trial in patients following bunionectomy surgery, and expects to report topline data in the second quarter of 2018. The Company expects to initiate a second Phase 3 trial in patients following abdominoplasty surgery in the third quarter of 2018.
About Avenue Therapeutics
Avenue Therapeutics, Inc. (“Avenue”), a Fortress Biotech (NASDAQ:FBIO) Company, 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 is currently evaluating IV tramadol in a pivotal Phase 3 program for the management of postoperative pain. Avenue is headquartered in New York City. For more information, visit www.avenuetx.com.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain of its subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensings, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.
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