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.
Lotus Clinical Research worked closely with Innocoll on this successful pivotal Phase 3 trial in abdominoplasty, providing scientific and regulatory consulting and conducting the study within our CRO and the ERG site network.
Lotus Clinical Research worked closely with Innocoll on the design of both new Phase 3 trials, and is currently conducting both studies within our CRO and site network:
Innocoll Biotherapeutics plc Announces First Patients In Phase 3 Clinical Trials for Label Expansion of Xaracoll® (bupivacaine hydrochloride) Implant
Lotus Clinical Research has worked with Concentric for several years and through multiple studies on their novel non-opioid analgesic vocacapsaicin. Recently, Lotus CRO has been instrumental in the study design..
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
Baudax Bio Non-Opioid Pain Drug Approval: In February, FDA granted approval to longtime Lotus client/ collaborator Baudax Bio’s non-opioid postsurgical pain therapy ANJESO. Lotus designed and performed both the Phase 2 and Phase 3 programs for this drug, with extensive scientific..
In September 2019, Lotus acquired HD Research, a network of specialty US analgesic research sites run by board certified anesthesiologists Harold Minkowitz, MD and David Leiman, MD. The core mission of our combined company is to standardize recruitment of chronic pain clinical trials using the same methodology Lotus used to standardize recruited models in acute … 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
At Lotus Clinical Research, the safety of our patients, employees and customers remains our highest priority.
In the coming weeks and months, in accordance with public health department…
September is Pain Awareness Month! Lotus Clinical Research’s mission is to reduce prescription drug misuse and abuse by inventing and validating scientific technologies that improve analgesic study design and conduct.
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