Clinical investigation of neuraxially administered drugs: a regulatory perspective.

摘要

The article "Neostigmine decreases bupivacaine use by patient-controlled epidural analgesia during labor: a randomized controlled study" by Ross et al., which appears in this issue of Anesthesia & Analgesia, discusses a clinical trial that assessed the bupivacaine-sparing properties of neostigmine. As stated in the article, the authors are the sponsors of an Investigational New Drug (IND) application for the intrathecal administration of neostigmine; however, in the study cited above, neostigmine was administered via an epidural route. We will briefly address the regulatory aspects involved in the submission of an IND for neuraxially administered drugs, including a discussion of whether the safety information contained in an IND permitting drug administration via the intrathecal route may be applied to drug administration via the epidural route.