Therapeutics Company Reaches Key FDA Agreement For IV Tramadol
Avenue Therapeutics and FDA Reach Key Agreement on Phase 3 Safety Study for IV Tramadol.
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Avenue Therapeutics Inc. (NASDAQ: ATXI), a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol, has announced a significant breakthrough. The company has reached a final agreement with the U.S. Food and Drug Administration (FDA) for the Phase 3 safety study of IV Tramadol.
IV Tramadol is a centrally acting analgesic that has a unique dual mechanism of action. It inhibits norepinephrine reuptake and enhances serotonin release, affecting both the monoaminergic pathway and the opioid receptor pathway. The drug aims to provide patients with relief from moderate to moderately severe pain without the risks associated with non-steroidal anti-inflammatory drugs (NSAIDs) and more potent opioids.
The agreed-upon Phase 3 study will be a randomized, double-blind, placebo-controlled trial to assess the safety of IV Tramadol in approximately 500 patients. The patients will be undergoing bunionectomy, a common and painful foot surgery.
The primary endpoint for this study will be the safety profile of IV Tramadol, including common opioid-related adverse events such as nausea, vomiting, dizziness, and somnolence. The secondary endpoint will be the assessment of pain intensity over 48 hours using the Sum of Pain Intensity Differences (SPID) score.
If approved, IV Tramadol could become a potential alternative to current pain management drugs, offering healthcare providers and patients a new tool in the fight against post-operative pain.
Avenue Therapeutics' commitment to developing safer, more effective treatments for pain is a testament to the power of innovation in the pharmaceutical industry. As they move forward with this pivotal safety study, all eyes will be on them and the potential impact of their work on millions of patients worldwide.
Please note: This article is for informational purposes only and should not be used as a replacement for professional medical advice.
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