Effectiveness, Safety, and Tolerability of Nabiximols Oromucosal Spray vs Typical Oral Long-Acting Opioid Analgesics in Patients with Severe Neuropathic Back Pain: Analysis of 6-Month Real-World Data from the German Pain e-Registry.

" : Funding sources : Analyses were funded by an unrestricted grant from Almirall S.A. The concept for evaluating routine data collected via the GPeR was developed by Dr. Ueberall at the Institute of Neurological Sciences on behalf of the German Pain Association (Deutsche Gesellschaft für Schmerzmedizin) and German Pain League (Deutsche Schmerzliga). Its realization has been funded in part (∼25%) by an unrestricted scientific grant from Almirall Hermal, Germany. Neither Almirall, nor any of its employees, exerted any influence on data acquisition, the conduct of this analysis, or interpretation and publication of the results. The GPeR is hosted by an independent contract research organization by order of the German Pain Association, is under control of the Institute of Neurological Sciences, and has been collecting standardized real-world data from daily routine medical care since January 2000.: Disclosure and conflicts of interest: Drs. Ueberall and Mueller-Schwefe are physicians and independent of any significant/relevant financial or other relationship to the sponsor, apart from minor reimbursements for occasional lecture or consulting fees. Both are honorary members of the management boards of the German Pain Association and German Pain League. Dr. Ueberall has received financial support and/or expenses in form of research funds, consultancy fees, and/or renumerations for lecture activities from Allergan, Almirall, Amicus Therapeutics, Aristo Pharma, Bionorica, Glaxo Smith Kline, Grünenthal, Hapa Medical, Hexal, IMC, Kyowa-Kirin, Labatec, Mucos, Mundipharma, Nestle, Pfizer, Recordati, Servier, SGP-Pharma, Shionogi, Spectrum Therapeutics, Teva, and Tilray. Dr. Mueller-Schwefe has received financial support and/or expenses in the form of research funds, consultancy fees, and/or remunerations for lecture activities from Allergan, Almirall, Grünenthal, Mundipharma, Pfizer, PharmAllergan, ProStrakan, and Teva. Dr. Essner is a veterinarian and works as a scientific and medico-legal consultant for various pharmaceutical companies. Dr. Essner has received honoraria for consultancy services from Almirall Hermal GmbH and Granzer Regulatory Consulting & Service. Dr. Vila Silván is a physician and works as the Global Medical Advisor CNS for Almirall S.A. (Barcelona, Spain). Dr. Vila Silván is a full-time employee of Almirall S.A. commercialiser of Sativex across EU countries.: Study registration: European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP), European Union Electronic Register of Post-Authorisation Studies (EU PAS Register) number EUPAS38969."

" : Funding sources : Analyses were funded by an unrestricted grant from Almirall S.A. The concept for evaluating routine data collected via the GPeR was developed by Dr. Ueberall at the Institute of Neurological Sciences on behalf of the German Pain Association (Deutsche Gesellschaft für Schmerzmedizin) and German Pain League (Deutsche Schmerzliga). Its realization has been funded in part (∼25%) by an unrestricted scientific grant from Almirall Hermal, Germany. Neither Almirall, nor any of its employees, exerted any influence on data acquisition, the conduct of this analysis, or interpretation and publication of the results. The GPeR is hosted by an independent contract research organization by order of the German Pain Association, is under control of the Institute of Neurological Sciences, and has been collecting standardized real-world data from daily routine medical care since January 2000.: Disclosure and conflicts of interest: Drs. Ueberall and Mueller-Schwefe are physicians and independent of any significant/relevant financial or other relationship to the sponsor, apart from minor reimbursements for occasional lecture or consulting fees. Both are honorary members of the management boards of the German Pain Association and German Pain League. Dr. Ueberall has received financial support and/or expenses in form of research funds, consultancy fees, and/or renumerations for lecture activities from Allergan, Almirall, Amicus Therapeutics, Aristo Pharma, Bionorica, Glaxo Smith Kline, Grünenthal, Hapa Medical, Hexal, IMC, Kyowa-Kirin, Labatec, Mucos, Mundipharma, Nestle, Pfizer, Recordati, Servier, SGP-Pharma, Shionogi, Spectrum Therapeutics, Teva, and Tilray. Dr. Mueller-Schwefe has received financial support and/or expenses in the form of research funds, consultancy fees, and/or remunerations for lecture activities from Allergan, Almirall, Grünenthal, Mundipharma, Pfizer, PharmAllergan, ProStrakan, and Teva. Dr. Essner is a veterinarian and works as a scientific and medico-legal consultant for various pharmaceutical companies. Dr. Essner has received honoraria for consultancy services from Almirall Hermal GmbH and Granzer Regulatory Consulting & Service. Dr. Vila Silván is a physician and works as the Global Medical Advisor CNS for Almirall S.A. (Barcelona, Spain). Dr. Vila Silván is a full-time employee of Almirall S.A. commercialiser of Sativex across EU countries.: Study registration: European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP), European Union Electronic Register of Post-Authorisation Studies (EU PAS Register) number EUPAS38969."

"This noninterventional treatment evaluation was conducted in line with the principles of the Declaration of Helsinki, conformed to relevant national and regulatory requirements, and was approved by the ethics committees of the German Pain Association and German Pain League. Patients and physicians provided written informed consent before participation in the GPeR and agreed to the use of their anonymized data for health care research purposes. The study was registered in the electronic database of the European Medicine Agency for noninterventional studies (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [ENCEPP]: European Union Electronic Register of Post-Authorisation Studies [EU PAS Register] number EUPAS38969). All analyses were performed on anonymized data to comply with national guidelines on the protection of data privacy and the EU General Data Protection Regulation. Use of the electronic documentation platform iDocLive® (O.Meany MD&PM GmbH, Nürnberg, Germany) and access to the GPeR was free of charge for members of the German Pain Association and for all patients, regardless of their insurance status.  : Funding sources : Analyses were funded by an unrestricted grant from Almirall S.A. The concept for evaluating routine data collected via the GPeR was developed by Dr. Ueberall at the Institute of Neurological Sciences on behalf of the German Pain Association (Deutsche Gesellschaft für Schmerzmedizin) and German Pain League (Deutsche Schmerzliga). Its realization has been funded in part (∼25%) by an unrestricted scientific grant from Almirall Hermal, Germany. Neither Almirall, nor any of its employees, exerted any influence on data acquisition, the conduct of this analysis, or interpretation and publication of the results. The GPeR is hosted by an independent contract research organization by order of the German Pain Association, is under control of the Institute of Neurological Sciences, and has been collecting standardized real-world data from daily routine medical care since January 2000.: Disclosure and conflicts of interest: Drs. Ueberall and Mueller-Schwefe are physicians and independent of any significant/relevant financial or other relationship to the sponsor, apart from minor reimbursements for occasional lecture or consulting fees. Both are honorary members of the management boards of the German Pain Association and German Pain League. Dr. Ueberall has received financial support and/or expenses in form of research funds, consultancy fees, and/or renumerations for lecture activities from Allergan, Almirall, Amicus Therapeutics, Aristo Pharma, Bionorica, Glaxo Smith Kline, Grünenthal, Hapa Medical, Hexal, IMC, Kyowa-Kirin, Labatec, Mucos, Mundipharma, Nestle, Pfizer, Recordati, Servier, SGP-Pharma, Shionogi, Spectrum Therapeutics, Teva, and Tilray. Dr. Mueller-Schwefe has received financial support and/or expenses in the form of research funds, consultancy fees, and/or remunerations for lecture activities from Allergan, Almirall, Grünenthal, Mundipharma, Pfizer, PharmAllergan, ProStrakan, and Teva. Dr. Essner is a veterinarian and works as a scientific and medico-legal consultant for various pharmaceutical companies. Dr. Essner has received honoraria for consultancy services from Almirall Hermal GmbH and Granzer Regulatory Consulting & Service. Dr. Vila Silván is a physician and works as the Global Medical Advisor CNS for Almirall S.A. (Barcelona, Spain). Dr. Vila Silván is a full-time employee of Almirall S.A. commercialiser of Sativex across EU countries.: Study registration: European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP), European Union Electronic Register of Post-Authorisation Studies (EU PAS Register) number EUPAS38969."