Pacira Biosciences Announces Positive Topline Data From Phase 3 Study of Exparel as a Single-Dose Femoral Nerve Block in the Adductor Canal for Total Knee Arthroplasty

News & Press Lotus Clinical Research worked closely with Pacira on this successful pivotal Phase 3 trial in total knee arthroplasty (TKA), providing scientific consulting and conducting the study within our CRO and the ERG site network. ERG-Lotus was able enroll this study far more rapidly than a typical TKA study, while employing a relatively … Read more

Neil Singla, MD- Public Comments on FDA’s February 2022 Draft Guidance for Industry

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.

Press Release: Innocoll Biotherapeutics plc Announces First Patients In Phase 3 Clinical Trials for Label Expansion of Xaracoll® (bupivacaine hydrochloride) Implant

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

Zynrelef Approval and Labeling: Implications for Analgesic Drug Development

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

Lotus Clinical Research 2019-2020 Highlights

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..

Lotus Site Network

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

Postoperative Nausea and Vomiting (PONV)

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