Assessment of the consistency of absorption of dihydroergotamine following oral inhalation: Pooled results from four clinical studies

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 26, Issue 5, 2013, Pages 297-306

  Kellerman, Donald J ^a   Forst, Amy ^a   Combs, Daniel L ^b   Borland, Scott ^a   Kori, Shashidhar ^a  

^a MAP Pharmaceuticals Inc   (United States)

^b MAP Pharmaceuticals Inc ^*  (United States)

Author keywords

MAP0004; migraine; oral inhalation; pharmacokinetics; TEMPO inhaler

Indexed keywords

DIHYDROERGOTAMINE; KETOCONAZOLE; MAP 0004; MOXIFLOXACIN; PLACEBO; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG HALF LIFE; DRUG TOLERABILITY; FEMALE; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; METERED DOSE INHALER; MIGRAINE; NAUSEA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT RESPONSE;

ADMINISTRATION, INHALATION; ADULT; AREA UNDER CURVE; CLINICAL TRIALS AS TOPIC; DIHYDROERGOTAMINE; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; LUNG; MALE; METERED DOSE INHALERS; VASOCONSTRICTOR AGENTS;

EID: 84885000649     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2012.0999     Document Type: Article

References (18)

1. Newman S: Principles of metered-dose inhaler design. Respir Care. 2005;50:1177-1188. (Pubitemid 46173332)
2. Dickens G, Wermeling D, Matheny C, John W, Abramowitz W, Sista S, Foster T, and Choudhury S: Pharmacokinetics of flunisolide administered via metered dose inhaler with and without a spacer device and following oral administration. Ann Allergy Asthma Immunol. 2000;84:528-532.
3. Borgström L, Bengston T, Derom E, and Pauwels R: Variability in lung deposition of inhaled drug, within and between asthmatic patients, with a pMDI and a dry powder inhaler, Turbuhaler. Int J Pharm. 2000;193:227-230. (Pubitemid 30001866)
4. Shrewsbury S, Armer T, Newman S, and Pitcairn G: The TEMPO-Inhaler- results of preliminary tests in humans with a novel pressurized metered-dose inhaler (pMDI) aerosol delivery system. Proc Am Thor Soc. 2006;3:A81.
5. Jividen H: Nausea associated with dihydroergotamine (DHE) is a function of maximum concentration and not route of administration. Presented at the 53rd Annual Scientific Meeting of the American Headache Society, Washington, DC, June 2-5, 2011.
6. Cook R, Shrewsbury S, and Ramadan N: Reduced adverse event profile of orally inhaled DHE (MAP0004) vs IV DHE: potential mechanism. Headache. 2009;49:1423-1434.
7. Forst A, Febbraro S, Kellerman D, Kori S, WuTann L, Thomas T, and Taylor G: An open-label, two-period crossover study comparing the pharmacokinetics and tolerability of LEVADEX-(MAP0004, orally inhaled DHE) and intravenous DHE (DHE45-) in smoking and non-smoking adult volunteers. [Abstract] Headache. 2011;51(Suppl 1):17.
8. Kellerman D, Kori S, Forst A, Chang J, Febbraro S, WuTann L, Thomas T, Taylor G, and Dodick DW: Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans. Cephalagia. 2012;32:150-158.
9. Shrewsbury S, Cook R, Taylor G, Edwards C, and Ramadan N: Safety and pharmacokinetics of dihydroergotamine mesylate administered via a novel (TEMPO-) inhaler. Headache. 2008;48:355-367. (Pubitemid 351517766)
10. Shrewsbury S, Kori S, Miller D, Pedinoff A, and Weinstein S: Randomized, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of LEVADEX (orally-inhaled DHE) in adult asthmatics. Curr Med Res Opin. 2008;24:1977-1985.
11. Humbert H, Denouel J, Chervet JP, Lavene D, and Kiechel JR: Determination of sub-nanogram amounts of dihydroergotamine in plasma and urine using liquid chromatography and fluorometric detection with off-line and on-line solid-phase drug enrichment. J Chromatogr. 1987;417: 319-329. (Pubitemid 17093596)
12. Gibaldi M, and Perrier D: Pharmacokinetics, 2nd ed, Chapter 11 and Appendix D. Marcel Dekker, New York, NY; 1982.
13. Dolovich M, Sanchis J, Rossman C, and Newhouse T: Aerosol penetrance: a sensitive index of peripheral airways obstruction. J Appl Physiol. 1976;40:468-471.
14. Dalby C, Polanowski T, Larsson T, Borgström L, Edsbä cker S, and Harrison TW: The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial. Respir Res. 2009;10:104.
15. Maurer G, and Frick W: Elucidation of the structure and receptor binding studies of the major primary, metabolite of dihydroergotamine in man. Eur J Clin Pharmacol. 1984; 26:463-470. (Pubitemid 14149126)
16. Delaforge M, Riviere R, Sartori E, Doignon JL, and Grognet JM: Metabolism of dihydroergotamine by cytochrome P-450 similar to that involved in the metabolism of macrolide antibiotics. Xenobiotica. 1989;19:1285-1295. (Pubitemid 19275642)
17. Aurora S, Silberstein S, Kori S, Tepper S, Borland S, Wang M, and Dodick D: MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Headache. 2011;51:507-517.
18. Winner P, Ricalde O, Le Force B, Saper J, and Margul B: A double-blind study of subcutaneous dihydroergotamine vs subcutaneous sumatriptan in the treatment of acute migraine. Arch Neurol. 1996;53:180-184. (Pubitemid 26055266)