Avenue Therapeutics shares shot up over 70% after the company announced it has finalized an agreement with the US Food and Drug Administration (FDA) for the Phase 3 safety study protocol of intravenous (IV) tramadol.
The drug is under development for managing acute post-operative pain in medically supervised settings.
The specialty pharmaceutical company specializing in neurologic disease therapies said the study aims to assess the safety profile of IV tramadol in comparison to IV morphine, particularly focusing on the risk of opioid-induced respiratory depression.
“We have worked collaboratively with the FDA over the last year to design a study that will address a theoretical safety risk,” Avenue CEO Dr Alexandra MacLean commented in a statement.
“We are pleased with the agreed-upon plan for the clinical trial and believe that this trial will support a safe profile for IV tramadol administration for acute pain in the postoperative period.”
Pending necessary financing, potentially through a strategic partnership, Avenue said it plans to initiate the Phase 3 safety study as soon as possible. Positive outcomes could lead to FDA approval for IV tramadol, offering an improved treatment option for US patients managing post-operative pain.
After trading as high as $0.33, Avenue's shares were 60% higher at $0.28 by 11am in New York.