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news.QrxPharma, a developer and commercializer of therapies for pain management and central nervous system (CNS) disorders, has concluded a comparative double-blind, randomized, fixed dose Phase 3 study of the tolerability and safety profile of MoxDuo IR to equi-analgesic doses of either morphine or oxycodone alone.
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The results of the trial suggested shorter and less severe periods of respiratory depression when treated with MoxDuo IR, compared to morphine or oxycodone.
The trial involved approximately 375 patients.
Additionally, the occurrence of moderate to severe vomiting was reduced in MoxDuo IR treated subjects compared to patients receiving oxycodone alone at the same 24mg morphine equivalent dose.
The company continues to expect to file a new drug application (NDA) with the FDA for MoxDuo IR within the next two months.
QrxPharma managing director and CEO John Holaday said the results of this study demonstrated that MoxDuo treated patients, while receiving effective pain relief, experienced less severe respiratory depression, which is a major safety advantage.
"MoxDuo’s favourable side effect profile, when compared head-to-head to current standards of care, distinguishes the product from other acute pain opioids in the clinical marketplace," Holaday said.