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Avenue Therapeutics Finalizes Phase 3 Study for IV Tramadol with FDA
Avenue Therapeutics, a subsidiary of Fortress Bio, has reached a significant milestone in its quest to introduce new therapies for neurologic diseases. The company has finalized an agreement with the
The pivotal non-inferiority study will assess the risk of opioid-induced respiratory depression linked to opioid stacking in IV tramadol compared to IV morphine. The study will involve around 300 patients undergoing bunionectomy, comparing the effects of IV tramadol to IV morphine over a 48-hour post-operative period. This study follows the success of IV tramadol in two previous Phase 3 efficacy trials. Avenue Therapeutics' CEO, Dr.
Journey Medical Corporation Submits NDA for DFD-29 to Treat Rosacea
In another significant development, Journey Medical Corporation, also a
DFD-29, or Minocycline Hydrochloride Modified Release Capsules (40 mg), aims to treat both inflammatory lesions and erythema (redness) associated with rosacea. This submission follows the success of two Phase 3 clinical trials, which met all primary and secondary endpoints without significant safety issues.
Conclusion
These developments from Avenue Therapeutics and Journey Medical Corporation, subsidiaries of Fortress Bio, mark the start of an exciting year for the company. The progress in the development of IV tramadol and DFD-29 showcases Fortress Bio's commitment to advancing medical treatments and enhancing patient care. These milestones reflect the company's strategic direction and potential in 2024, potentially offering hope for new, effective treatment options in neurology and dermatology.
Source: Plato Data Intelligence
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