Pacira Biosciences Announces Positive Topline Data From Phase 3 Study of Exparel as a Single-Dose Sciatic Nerve Block in the Popliteal Fossa for Bunionectomy

新闻 & 新闻 Lotus Clinical Research worked closely with Pacira on this successful pivotal Phase 3 trial in bunionectomy, providing scientific consulting and conducting the study within our CRO and the ERG site network. Lotus applied our extensive expertise in the bunionectomy model and deployed our placebo response mitigation training program in order to minimize … 阅读更多

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

新闻 & 新闻 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, 在使用相对… 阅读更多

Neil Singla, MD- Public Comments on FDA’s February 2022 Draft Guidance for Industry

The draft guidance document can be found here. 4月8日, 2022 RE: Development of Non-Opioid Analgesics for 剧烈的疼痛: Guidance for Industry; Draft Date February 7, 2022 Docket ID: FDA-2021-N-0556 Dear Reviewer, Below please find my comments on FDA’s draft document: Development of Non-Opioid Analgesics for 剧烈的疼痛: Guidance for Industry, 2月7日, 2022. … 阅读更多

Innocoll Announces Positive Topline Results for XARACOLL® (bupivacaine hydrochloride) Implant in a Phase 3 Study to Support Expanded Use

新闻 & 新闻 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 pioneered the development of abdominoplasty as a postsurgical pain model beginning in 2010, 设计并执行了… 阅读更多

新闻 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 Results of implant’s safety, efficacy and pharmacokinetics for … 阅读更多

新闻 Release: Concentric Analgesics Announces Positive Topline Results from Phase 2 Clinical Trial of Vocacapsaicin (CA-008) in Total Knee Arthroplasty Surgery

Lotus Clinical Research has worked with Concentric for several years and through multiple studies on their novel non-opioid analgesic vocacapsaicin. 最近, Lotus CRO has been instrumental in the study design, 协议编写与开发, 统计分析, management and oversight of Concentric’s total knee arthroplasty clinical trials at Lotus sites. Lotus also conducted Concentric’s earlier bunion … 阅读更多

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 … 阅读更多

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 and operational input at every stage. The Baudax bunionectomy and abdominoplasty pivotal surgical studies … 阅读更多

Lotus站点网络

2019年9月, 莲花收购HD Research, a network of specialty US analgesic research sites run by board certified anesthesiologists Harold Minkowitz, MD和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 … 阅读更多

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. 救援和. Prophylaxis One key study conduct issue to manage in PONV trials is the threshold for … 阅读更多