Qrxpharma Announces Successful Completion of Phase 3 Trials of MoxDuo
After a meeting with United States Food and Drug Administration (FDA), QRxPharma Limited announced the successful completion of its third pivotal phase 3 registration trial for immediate-release MoxDuo.
In a study related to the safety of MoxDuo, researchers compared a flexible dose against a fixed low-dose regimen for managing moderate to severe pain following total knee replacement surgery and findings suggested that the patients in the flexible dose treatment group achieved statistically superior pain reduction compared to those receiving the lower dose.
“This is a major milestone for QRxPharma. We not only achieved the primary analgesic endpoint, but also believe the basic clinical requirements for NDA filing have been satisfied. We can see the goal line”, said Dr. John Holaday, Managing Director and CEO, QRxPharma. “Our upcoming pre-NDA meeting with the FDA will explore QRxPharma’s regulatory strategy and provide preliminary feedback about the sufficiency of our studies to set the stage for MoxDuo approval”.
After completing this phase successfully, QRxPharma believes that it has fulfilled all the basic clinical data requirements to enable NDA filing for MoxDuo. It is focusing on the acute pain market which is a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the US.
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