Biotech Values

[NP1986]

Why would 797 need to be limited to acute use in patients who cannot tolerate oxycodone? Efficacy was comparable to oxycodone and the oxycodone arm had a much larger percentage of patients withdraw due to AEs (34% compared to just 6% for 797 arm).

Comparable efficacy in a relatively small trial is not much to go by. It's possible that in a larger, non-inferiority trial that ARRY-797 doesn't show comparable efficacy, in which case I believe oxycodone would be preferred, especially since it is likely to be cheaper.

Also, if we were to assume QTc intervals stayed within the interval cited in the PR (not sure if that's plausible), couldn't 797 still be an option for chronic use? Note that for chronic use, due to entirely different MoA, 797 presumably wouldn't have the addictive issues that oxycodone has.

A lack of dependence would be an advantage, but IMO it would be overshadowed by the CV safety concerns. Even if it turns out to be inconsequential, I think regulatory agencies will want to see long-term safety data before approving it for chronic use.