{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:11:45Z","timestamp":1760145105132},"reference-count":10,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2018,6,16]],"date-time":"2018-06-16T00:00:00Z","timestamp":1529107200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2018,6,16]],"date-time":"2018-06-16T00:00:00Z","timestamp":1529107200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"Insys Development Company, Inc.","award":["Study funding","Editorial support funding"],"award-info":[{"award-number":["Study funding","Editorial support funding"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Drug Investig"],"published-print":{"date-parts":[[2018,8]]},"DOI":"10.1007\/s40261-018-0658-9","type":"journal-article","created":{"date-parts":[[2018,6,16]],"date-time":"2018-06-16T14:16:20Z","timestamp":1529158580000},"page":"715-726","update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Pharmacokinetics of Fentanyl Sublingual Spray in Opioid-Na\u00efve Participants: Results of a Phase 1, Multiple Ascending Dose Study"],"prefix":"10.1007","volume":"38","clinical-trial-number":[{"clinical-trial-number":"nct02641340","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Richard L.","family":"Rauck","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D. Alexander","family":"Oh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neil","family":"Singla","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Koch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neha","family":"Parikh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Srinivas","family":"Nalamachu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin","family":"Yu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"James","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2018,6,16]]},"reference":[{"key":"658_CR1","doi-asserted-by":"publisher","first-page":"S3","DOI":"10.1016\/0885-3924(92)90047-L","volume":"7","author":"TH Stanley","year":"1992","unstructured":"Stanley TH. The history and development of the fentanyl series. J Pain Symptom Manag. 1992;7:S3\u20137.","journal-title":"J Pain Symptom Manag"},{"key":"658_CR2","doi-asserted-by":"publisher","first-page":"230","DOI":"10.1007\/BF03178274","volume":"5","author":"L Nelson","year":"2009","unstructured":"Nelson L, Schwaner R. Transdermal fentanyl: pharmacology and toxicology. J Med Toxicol. 2009;5:230\u201341.","journal-title":"J Med Toxicol"},{"key":"658_CR3","unstructured":"SUBLIMAZE\u00ae (fentanyl citrate) injection [package insert]. Lake Forest: Akorn, Inc., 2012."},{"key":"658_CR4","unstructured":"Subsys\u00ae (fentanyl sublingual spray), CII [package insert]. Chandler: INSYS Therapeutics, Inc, 2014."},{"key":"658_CR5","unstructured":"DURAGESIC\u00ae (Fentanyl Transdermal System) for transdermal administration, CII [package insert]. Titusville: Janssen Pharmaceuticals, Inc, 2017."},{"key":"658_CR6","doi-asserted-by":"publisher","first-page":"236","DOI":"10.1016\/j.clinthera.2013.02.017","volume":"35","author":"N Parikh","year":"2013","unstructured":"Parikh N, Goskonda V, Chavan A, Dillaha L. Single-dose pharmacokinetics of fentanyl sublingual spray and oral transmucosal fentanyl citrate in healthy volunteers: a randomized crossover study. Clin Ther. 2013;35:236\u201343.","journal-title":"Clin Ther"},{"key":"658_CR7","doi-asserted-by":"publisher","first-page":"1915","DOI":"10.1080\/03007995.2017.1352496","volume":"33","author":"R Rauck","year":"2017","unstructured":"Rauck R, Oh DA, Parikh N, Koch C, Singla N, Yu J, et al. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a single ascending dose study in opioid-na\u00efve healthy volunteers. Curr Med Res Opin. 2017;33:1915\u201320.","journal-title":"Curr Med Res Opin"},{"key":"658_CR8","doi-asserted-by":"publisher","first-page":"1921","DOI":"10.1080\/03007995.2017.1371681","volume":"33","author":"RL Rauck","year":"2017","unstructured":"Rauck RL, Oh DA, Singla N, Koch C, Parikh N, Nalamachu S, et al. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a multiple ascending dose study in opioid-na\u00efve healthy volunteers. Curr Med Res Opin. 2017;33:1921\u201333.","journal-title":"Curr Med Res Opin"},{"key":"658_CR9","doi-asserted-by":"publisher","first-page":"1278","DOI":"10.1023\/A:1026451721686","volume":"17","author":"BP Smith","year":"2000","unstructured":"Smith BP, Vandenhende FR, DeSante KA, Farid NA, Welch PA, Callaghan JT, et al. Confidence interval criteria for assessment of dose proportionality. Pharm Res. 2000;17:1278\u201383.","journal-title":"Pharm Res"},{"key":"658_CR10","doi-asserted-by":"publisher","first-page":"391","DOI":"10.1007\/s40261-013-0079-8","volume":"33","author":"N Parikh","year":"2013","unstructured":"Parikh N, Goskonda V, Chavan A, Dillaha L. Pharmacokinetics and dose proportionality of fentanyl sublingual spray: a single-dose 5-way crossover study. Clin Drug Investig. 2013;33:391\u2013400.","journal-title":"Clin Drug Investig"}],"container-title":["Clinical Drug Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40261-018-0658-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-018-0658-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-018-0658-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T17:42:13Z","timestamp":1628617333000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40261-018-0658-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,6,16]]},"references-count":10,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2018,8]]}},"alternative-id":["658"],"URL":"https:\/\/doi.org\/10.1007\/s40261-018-0658-9","relation":{},"ISSN":["1173-2563","1179-1918"],"issn-type":[{"value":"1173-2563","type":"print"},{"value":"1179-1918","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,6,16]]},"assertion":[{"value":"16 June 2018","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"Funding for this study and editorial support was provided by Insys Development Company, Inc., Chandler, AZ.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"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\u2019 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\u2019Up, 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\u2019 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.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"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.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained prior to study participation.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}