Jumpin, Yes, a lot of questions, though they haven't had that much time to analyze the data (the database was unblinded on Sept 7), and we'll also have to wait for the maintenance of analgesia data analysis.
But the big question is why the lower 300 mg dose worked better than the higher doses (600 mg, 900 mg) in Acute RD (REMI-1), while the opposite was true in the Chronic RD (REMI-2) part of the trial where the higher doses worked better.
Normally you expect greater efficacy at the higher doses, so what might have happened? It's a small trial, made smaller by the various dropouts, and the dose of opioid used didn't produce sufficient RD in a good number of the patients (5 patients in REMI-2). Another variable was that the 300 mg portion of the trial was placebo controlled, while the higher 600/900 mg dosing portion was open label.
Anyway, summarizing the preliminary results -
Acute RD - 300 mg ---- Stat Sig - Yes
Acute RD - 600,900 mg - Stat Sig - No
Chronic RD - 300 mg --- Stat Sig - No
Chronic RD - 600,900 mg - Stat Sig - Yes
Maintenance of Analgesia - Data analysis coming later
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