Below please find my comments on FDA’s draft document: Development of Non-Opioid Analgesics for Acute Pain: Guidance for Industry, dated February 7, 2022. I am a board-certified anesthesiologist and Chief Scientific Officer of Lotus Clinical Research, LLC, a contract research organization, regulatory consulting firm and research site network specializing in analgesic clinical trials.
All data used in this analysis is from public sources, and is linked/ cited where possible. INTRODUCTION/ HISTORY Heron Therapeutics’ Zynrelef (formerly called HTX-011) represents the first novel infiltration analgesic approved by FDA since Pacira’s Exparel, which was initially approved in 2011. Heron’s clinical development pathway and regulatory process are therefore of high interest to … Read more
The conduct of PONV clinical trials has significant impact on their assay sensitivity. This is in part due to the strict experimental controls needed to demonstrate an effect in PONV, which are sometimes contrary to standard clinical practice. Rescue vs. Prophylaxis One key study conduct issue to manage in PONV trials is the threshold for … Read more
The prevailing soft tissue acute pain surgical models (hemorrhoidectomy, herniorrhaphy, hysterectomy, laparoscopic cholecystectomy, colon surgery) are slow to recruit and present financial and logistical challenges
Bunionectomy as an Analgesic Model In analgesic clinical trials, selecting the type of model to use can be challenging as each has their own pros and cons. As an analgesic model, Bunionectomy has excellent assay sensitivity. In the paper linked below our Chief Scientific Officer, Dr. Neil Singla, discusses the clinical and experimental characteristics of four acute surgical … Read more
3rd Molar Extraction as an Analgesic Model In analgesic clinical trials, selecting the type of model to use can be challenging as each has their own pros and cons. As an analgesic model, 3rd molar extraction has excellent assay sensitivity. Additionally, because of its low cost and rapid enrollment, it can be used to cost effectively dose … Read more