MoxDuo IV: Phase II data

In a double-blind, active-controlled, German Phase II trial in 40 patients, SPID scores at 65 minutes post-dosing were 50% higher for MoxDuo IV vs. IV morphine alone, with 67% of MoxDuo IV patients reporting "good to excellent" global improvement vs. 53% for morphine alone. SPID scores during the entire 48-hour study period were 10% higher for MoxDuo IV compared to morphine alone. Additionally, patients in the MoxDuo IV arm received an average of 13 doses over the entire study period vs. 17 doses for patients receiving morphine alone.

MoxDuo IV was well tolerated, with fewer patients experiencing mild and moderate-to-severe nausea vs. morphine alone (24% vs. 53% and 5% vs. 11%, respectively), and fewer patients experiencing mild and severe vomiting vs. control (10% vs. 16% and 0% vs. 11%, respectively). The study consisted of an initial 65 minute dose-titration period in which fixed doses of MoxDuo IV or IV morphine were given once every 5 minutes until a strong analgesic effect occurred. The dose-titration period was followed by a 47-hour patient controlled analgesia phase in which patients could administer a fixed amount of study drug as frequently as once every 6 minutes. ...