Rauck, Richard L.
Oh, D. Alexander
Singla, Neil
Koch, Christian
Parikh, Neha
Nalamachu, Srinivas
Yu, Jin
James, Steven
Clinical trials referenced in this document:
Documents that mention this clinical trial
Pharmacokinetics of Fentanyl Sublingual Spray in Opioid-Naïve Participants: Results of a Phase 1, Multiple Ascending Dose Study
https://doi.org/10.1007/s40261-018-0658-9
Funding for this research was provided by:
Insys Development Company, Inc. (Study funding, Editorial support funding)
Article History
First Online: 16 June 2018
Compliance with ethical standards
:
: Funding for this study and editorial support was provided by Insys Development Company, Inc., Chandler, AZ.
: RR reports serving as a consultant or advisory board member or receiving research funding from the Alfred Mann Foundation, Archimedes, BioDelivery Sciences International, Inc., Insys Development Company, Inc., Jazz Pharmaceuticals, Meda, Medasys, Inc., and Medtronic, Inc.; serving on the speakers’ bureau for Jazz Pharmaceuticals; and receiving research funding from Alfred Mann Foundation, Bioness, Boston Scientific, Collegium Pharmaceuticals, CNS Therapeutics, Jazz Pharmaceuticals, Medtronic, Inc., Myoscience, NeurAxon, Inc., Spinal Modulation, Spinal Restoration, and St. Jude Medical. DAO, NP, JY, and SJ are employees of and hold stock in Insys Development Company, Inc. CK is an employee of Lotus Clinical Research, LLC, which received grants for conducting clinical investigations in connection with this trial. NS is owner and founder of Lotus Clinical Research, LLC, which received grants for conducting clinical investigations in connection with this trial; reports receiving research funding from Acacia Pharma Ltd, AcelRx Pharmaceuticals, Inc., Alkermes, Inc., AMAG Pharmaceuticals, Inc., Aponia Laboratories, Inc., Astellas Pharma B.V., AstraZeneca L.P., Auxilium Pharmaceuticals, Inc., Biogen Idec MA Inc., Biom’Up, Bonti, Inc., Braeburn Pharmaceuticals, Inc., Cadence Pharmaceuticals, Inc., Cephalon, Inc., Charleston Laboratories, Inc., Chromocell Corporation, Collegium Pharmaceutical, Inc., Columbia Laboratories, Inc., Coronado Biosciences, Cubist Pharmaceuticals, Inc., Durect Corporation, Frazier Management, LLC, Grace Therapeutics LLC, Grifols, Inc., Heron Therapeutics, Inc., IMMPACT, Imprimis Pharmaceuticals, Inc., Innocoll Pharmaceuticals, Insys Therapeutics, Inc., iX Biopharma Ltd., KemPharm, Inc., KLSMC Stem Cells, Inc., Kowa Research Institute, Inc., Mallinckrodt Inc., a Covidien company, MedRx USA, Inc., Merck Sharp & Dohme Corp., Mira Pharma, Inc., Myoscience, Inc., Naurex, Inc., an affiliate of Allergan Sales, LLC, Nektar Therapeutics, Novartis Consumer Health, Inc., Novartis Pharmaceuticals Corporation, Pacira Pharmaceuticals, Inc., Pfizer, Inc., PPD Development, LLC, ProFibrix, Inc., Purdue Pharma L.P., QRxPharma, Inc., Recro Pharma, Inc., Regenesis Biomedical Inc., Revogenex, SAI MedPartners LLC, Shionogi Inc., Teva Pharmaceuticals USA, Trevena, Inc., Vertex Pharmaceuticals, Inc., VM Pharma LLC., WEX Pharmaceuticals, Inc. SN reports receiving research grants from Covidien and Endo Pharmaceuticals Inc.; serving on the speakers’ bureau for Archimedes, Covidien, Eli Lilly and Company, Johnson & Johnson, ProStrakan, and Teva Pharmaceuticals; and serving as a consultant for Depomed, Galena, Insys Development Company, Inc., Teva Pharmaceuticals, and Zogenix, Inc.
: All procedures in this study were in accordance with the 1964 Helsinki declaration (and its amendments). A valid Institutional Review Board (IRB) reviewed and approved the protocol before study initiation.
: Written informed consent was obtained prior to study participation.