FDA Approves Study Design for Avenue Therapeutics’ Innovative IV Tramadol Treatment: A Promising Step Towards Pain Relief

Avenue Therapeutics, Inc. (Nasdaq: ATXI) is pleased to announce that they have reached a milestone agreement with the U.S. Food and Drug Administration (“FDA”) on the design and statistical analysis approach of a Phase 3 safety study for intravenous tramadol, a drug in development for the treatment of acute post-operative pain.

The non-inferiority study objectives are to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking when using IV tramadol compared to IV morphine. This is a major step in Avenue’s progress to provide new therapeutic options for the treatment of neurologic diseases.

The study will seek to compare the effectiveness of IV tramadol and IV morphine for pain relief among post-bunionectomy patients in a 48-hour post-operative period. Given the safety and efficacy of IV tramadol that was demonstrated in a previous Phase 3 efficacy trial in the same surgical model, post bunionectomy patients will have the advantage of accessing IV hydromorphone, a Schedule II opioid, should they experience breakthrough pain. The primary goal of the study is to measure indicators of respiratory depression across both treatment therapies.

At Avenue, we believe IV tramadol is a safe and effective way to manage acute pain in the United States, with its innovative mixed modality mechanism of action and decades of clinical experience around the world.

IV tramadol’s uniqueness – a combination of opioid mu receptor agonism and serotonin and norepinephrine reuptake inhibition – presents a viable alternative to conventional opioids in the post-operative setting, reducing abuse potential and providing much-needed relief against pain. Our Phase 3 trials results have shown promise, and our hope is that IV tramadol will make a significant and positive difference in the pain treatment landscape of the country.

Avenue is excited to announce that they have submitted the revised protocol to the FDA along with the statistical plan, which reflects their now agreed upon study design, for final review. This year looks to be a great year for Avenue, with plans to initiate the Phase 3 safety study of their lead product candidate, IV tramadol, subject to obtaining the necessary financing.

Positive study outcomes could potentially lead to FDA approval of IV tramadol. On top of that, Avenue will provide updates in the coming weeks on their two earlier-stage clinical programs, AJ201 to treat spinal and bulbar muscular atrophy, and BAER101 for epilepsy.

With their dedication to delivering impactful therapies to treat patients with neurologic diseases and building shareholder value, Avenue is committed to making a meaningful difference in patients’ lives.

About Avenue Therapeutics

Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company making strides in providing therapies for neurologic diseases. Their development program holds three unique assets, the first-in-class AJ201 for spinal and bulbar muscular atrophy, BAER101, an oral small molecule selective GABA-A α2/3 receptor positive allosteric modulator and IV tramadol, currently in Phase 3 clinical development for the management of acute postoperative pain.

What began as an idea from Fortress Biotech, Inc. (Nasdaq: FBIO) has now become a reality in Miami, FL where Avenue is paving the way for new treatments and hope.

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