Avenue Therapeutics Announces Agreement with the FDA on the Study Design and Analysis Approach of the Phase 3 Safety Study for IV Tramadol

MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (“FDA”) on key elements of the Phase 3 safety study, including the primary endpoint and statistical analysis approach, for intravenous (IV) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The agreed upon non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.

The study will randomize post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Of note, IV tramadol demonstrated safety and efficacy in this same surgical model in a Phase 3 efficacy trial. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. The primary endpoint is a composite of elements indicative of respiratory depression.

"Based on IV tramadol's innovative mixed modality mechanism of action (agonism at the opioid mu receptor and reuptake inhibitor of serotonin and norepinephrine), decades of clinical experience in Europe and around the world, as well as the program’s positive data in two Phase 3 trials, we believe that IV tramadol will prove to be safe and effective in this final study and patient population," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “With over 100 million acute pain cases in the U.S. reported annually, patients and physicians seek an alternative pain management option with the potential to reduce the use of conventional opioids and the associated abuse potential in the post-operative setting, while effectively managing patient’s pain. We are confident that IV tramadol has the potential to overcome limitations of existing therapies and make a meaningful difference in the U.S. pain treatment landscape.”

Avenue is submitting the revised protocol to the FDA including the statistical plan, which reflects the now agreed upon study design, for final review. "Our goal is to initiate the Phase 3 safety study this year, subject to obtaining the necessary financing which could be provided through a strategic partnership, and we expect that a positive study outcome could result in the FDA approval of IV tramadol. Additionally, we plan to provide updates on Avenue’s two earlier-stage clinical programs in the coming weeks, including our lead product candidate, AJ201 to treat spinal and bulbar muscular atrophy, and BAER101 for epilepsy. We remain committed to Avenue’s mission of delivering impactful therapies to treat patients with neurologic diseases, while building shareholder value,” said Dr. MacLean.

About Avenue Therapeutics
Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER101, an oral small molecule selective GABA-A α2/3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute postoperative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com.

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Contact:
Jaclyn Jaffe
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com

Released July 25, 2023