Improved pharmacokinetics of sumatriptan with breath powered™ nasal delivery of sumatriptan powder

Headache

Volumn 53, Issue 8, 2013, Pages 1323-1333

  Obaidi, Mohammad ^b   Offman, Elliot ^a   Messina, John ^c   Carothers, Jennifer ^c   Djupesland, Per G ^d   Mahmoud, Ramy A ^c  

^a CELERION   (United States)

^b Clinical Development ^*

^c OptiNose US Inc   (United States)

^d OptiNose AS   (Norway)

Author keywords

bidirectional nasal delivery; bioavailability; Breath Powered nasal delivery; migraine; pharmacokinetics; sumatriptan

Indexed keywords

NOSE SPRAY; SUMATRIPTAN; SUMATRIPTAN SUCCINATE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL LABORATORY; COMPARATIVE STUDY; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG EXPOSURE; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; ELECTROCARDIOGRAM; FEMALE; FLUSHING; FOLLOW UP; HUMAN; HUMAN EXPERIMENT; INJECTION SITE REACTION; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; OPEN STUDY; OTORHINOLARYNGOLOGY DRUG DELIVERY DEVICE; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; VITAL SIGN;

BIDIRECTIONAL NASAL DELIVERY; BIOAVAILABILITY; BREATH POWERED NASAL DELIVERY; MIGRAINE; PHARMACOKINETICS; SUMATRIPTAN;

ADMINISTRATION, INTRANASAL; ADOLESCENT; ADULT; CROSS-OVER STUDIES; DRUG DELIVERY SYSTEMS; DRY POWDER INHALERS; FEMALE; HUMANS; MALE; MIDDLE AGED; NASAL CAVITY; RESPIRATION; SEROTONIN 5-HT1 RECEPTOR AGONISTS; SUMATRIPTAN; YOUNG ADULT;

EID: 84884127979     PISSN: 00178748     EISSN: 15264610     Source Type: Journal    
DOI: 10.1111/head.12167     Document Type: Article

References (26)

1. Erlichson K, Waight J,. Therapeutic applications for subcutaneous triptans in the treatment of migraine. Curr Med Res Opin. 2012; 28: 1231-1238.
2. 1B/1D agonists) in migraine: Detailed results and methods of a meta-analysis of 53 trials. Cephalalgia. 2002; 22: 633-658.
3. Dahlöf C,. Sumatriptan nasal spray in the acute treatment of migraine: A review of clinical studies. Cephalalgia. 1999; 19: 769-778.
4. 1B/1D agonists: A model with pharmacokinetic validation. Headache. 2004; 44: 142-147.
5. Salonen R, Ashford E, Dahlöf C, et al. Intranasal sumatriptan for the acute treatment of migraine. J Neurol. 1994; 241: 463-469.
6. Aurora SK, Kori SH, Barrodale P, McDonald SA, Haseley D,. Gastric stasis in migraine: More than just a paroxysmal abnormality during a migraine attack. Headache. 2006; 46: 57-63.
7. Aurora S, Kori S, Barrodale P, Nelsen A, McDonald S,. Gastric stasis occurs in spontaneous, visually induced, and interictal migraine. Headache. 2007; 47: 1443-1446.
8. Boyle R, Behan PO, Sutton JA,. A correlation between severity of migraine and delayed gastric emptying measured by an epigastric impedance method. Br J Clin Pharmacol. 1990; 30: 405-409.
9. Aurora SK, Papapetropoulos S, Kori SH, Kedar A, Abell TL,. Gastric stasis in migraineurs: Etiology, characteristics, and clinical and therapeutic implications. Cephalalgia. 2013; 33: 408-415.
10. Aggarwal R, Cardozo A, Homer JJ,. The assessment of topical nasal drug distribution. Clin Otolaryngol. 2004; 29: 201-205.
11. Djupesland PG, Skretting A, Winderen M, Holand T,. Breath actuated device improves delivery to target sites beyond the nasal valve. Laryngoscope. 2006; 116: 466-472.
12. Djupesland PG,. Nasal drug delivery devices: Characteristics and performance in a clinical perspective-A review. Drug Deliv Transl Res. 2013; 3: 42-62.
13. Sahin-Yilmaz A, Naclerio RM,. Anatomy and physiology of the upper airway. Proc Am Thorac Soc. 2011; 8: 31-39.
14. Duquesnoy C, Mamet JP, Sumner D, Fuseau E,. Comparative clinical pharmacokinetics of single doses of sumatriptan following subcutaneous, oral, rectal and intranasal administration. Eur J Pharm Sci. 1998; 6: 99-104.
15. Djupesland PG, Skretting A, Winderen M, Holand T,. Bi-directional nasal delivery of aerosols can prevent lung deposition. J Aerosol Med. 2004; 17: 249-259.
16. Djupesland PG, Skretting A,. Nasal deposition and clearance in man: Comparison of a bidirectional powder device and a traditional liquid spray pump. J Aerosol Med Pulm Drug Deliv. 2012; 25: 280-289.
17. Vause C, Bowen E, Spierings E, Durham P,. Effect of carbon dioxide on calcitonin gene-related peptide secretion from trigeminal neurons. Headache. 2007; 47: 1385-1397.
18. Luthringer R, Djupesland PG, Sheldrake CD, et al. Rapid absorption of sumatriptan powder and effects on glyceryl trinitrate model of headache following intranasal delivery using a novel bi-directional device. J Pharm Pharmacol. 2009; 61: 1219-1228.
19. U.S. Food and Drug Administration Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products-General considerations. 2003. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
20. Goadsby PJ,. A triptan too far. J Neurol Neurosurg Psychiatry. 1998; 64: 143-147.
21. Djupesland PG, Dočekal P, the Czech Migraine Investigators Group. Intranasal sumatriptan powder delivered by a novel breath-actuated bi-directional device for the acute treatment of migraine: A randomised, placebo-controlled study. Cephalalgia. 2010; 30: 933-942.
22. U.S. Food and Drug Administration. Summary basis of approval for NDA 20-626. August 26, 1997. http://www.accessdata.fda.gov/drugsatfda/nda/97/020626- imitrex-toc.cfm.
23. Kågedal M, Zingmark P-H, Hedlund C,. True nasopharyngeal absorption of zolmitriptan after administration via nasal spray in healthy volunteers. Am J Drug Deliv. 2005; 3: 133-140.
24. IMS National Prescription Audit, May 2010-April 2011.
25. Tzabazis A, Niv SH, Manering NA, et al. Trigeminal antihyperalgesic effect of intranasal carbon dioxide. Life Sci. 2010; 87: 36-41.
26. Headache Classification Subcommittee of the International Headache Society. The international classification of headache disorders, 2nd edn. Cephalalgia. 2004; 24 (Suppl. 1): 9-160.