Efficacy studies for pain are run in mostly male subjects.
Could this be contributing to late stage failures of active compounds?
Much of the data generated in preclinical efficacy studies for active compounds comes from male subjects. Some are concerned that hormonal cyclicality with female subjects will add variability and some have the misconception that there isn't much of a difference in response between the sexes.
In this webinar, we present data from a post-operative pain model that suggests the nerve fiber density and pain response between male and females is different. This leads to the question of whether sex differences could be contributing to the failure rate of therapeutic candidates reaching late clinical stages.
