Sumatriptan needle-free subcutaneous (Sumavel® DosePro™) approved for the acute treatment of migraine, with or without aura, and cluster headaches

Expert Review of Neurotherapeutics

Volumn 11, Issue 4, 2011, Pages 481-490

  Freitag, Frederick G ^a,b  

^a BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^b ROSALIND FRANKLIN UNIVERSITY OF MEDICINE AND SCIENCE   (United States)

Author keywords

central sensitization; cluster headache; IMITREX STATdose ; migraine headache; subcutaneous; sumatriptan; Sumavel DosePro

Indexed keywords

CALCITONIN GENE RELATED PEPTIDE; DIHYDROERGOTAMINE; DRUG METABOLITE; FLUNARIZINE; NOSE SPRAY; PHENELZINE; PIZOTIFEN; PLACEBO; SEROTONIN 1 AGONIST; SEROTONIN UPTAKE INHIBITOR; SUMATRIPTAN; TRICYCLIC ANTIDEPRESSANT AGENT; VERAPAMIL;

ABDOMEN; ALLODYNIA; ANALGESIA; ANGIOCARDIOGRAPHY; AREA UNDER THE CURVE; ARTICLE; BLOOD PRESSURE; CLINICAL ASSESSMENT; CLUSTER HEADACHE; COMPARATIVE STUDY; CORONARY ARTERY DISEASE; CUTANEOUS ALLODYNIA; DRUG APPROVAL; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG EXCRETION; DRUG EXPOSURE; DRUG FORMULATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; HUMAN; INJECTION SITE; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; MAXIMUM PLASMA CONCENTRATION; MIGRAINE WITH AURA; MIGRAINE WITHOUT AURA; NAUSEA; NEEDLE FREE; NEUROTRANSMISSION; PHONOPHOBIA; PHOTOPHOBIA; PLASMA PROTEIN BINDING; PRESCRIPTION; THIGH; THORAX PAIN; TREATMENT RESPONSE;

CLUSTER HEADACHE; DRUG ADMINISTRATION ROUTES; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIGRAINE DISORDERS; SEROTONIN 5-HT1 RECEPTOR AGONISTS; SUMATRIPTAN; TREATMENT OUTCOME;

EID: 79953735515     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/ern.11.41     Document Type: Article

References (29)

1. Ferrari MD, Roon KI, Lipton RB, Goadsby PJ. Oral triptans (serotonin 5-HT1B/1D agonists) in acute migraine treatment: a meta-analysis of 53 trials. Lancet 358, 1668-1675 (2001). (Pubitemid 33124324)
2. Humphrey PPA, Feniuk W, Perren MJ, Connor HE, Oxford AW, Coats IH. GR43175, a selective agonist for the 5-HT-1-like receptor in dog saphenous vein. Br. J. Clin. Pharmacol. 94, 1123-1132 (1988).
3. Moskowitz MA, Buzzi MG. Evidence for 5-HT1B/1D receptor medicating the antimigraine effect of sumatriptan and dihydroergotamine. Cephalalgia 11, 165-168 (1991).
4. Moskowitz MA. Neurogenic inflammation in the pathophysiology and treatment of migraine. Neurology 43(Suppl. 3), S16-S20 (1993).
5. Burstein R, Jakubowski M, Levy D. Anti-migraine action of triptans is preceded by transient aggravation of headache caused by activation of meningeal nociceptors. Pain 115, 21-28 (2005). (Pubitemid 40514451)
6. MacIntyre PD, Bhargava B, Hogg KJ, Gemmill JD, Hillis WS. Effect of subcutaneous sumatriptan, a selective 5HT-1 agonist on the systemic, pulmonary, and coronary circulation. Circulation 87, 401-405 (1993). (Pubitemid 23040908)
7. Scott AK, Walley T, Breckenridge AM, Lacey LF, Fowler PA. Lack of interaction between propanolol and sumatriptan. Br. J. Clin. Pharmacol. 32, 581-584 (1991).
8. Van Heckn AM, Depre M, De Schepper PJ, Fowler PA, Lacey JM, Durham JM. Lack of effect of flunarizine on the pharmacokinetics and pharmacodynamics of sumatriptan in healthy volunteers. Br. J. Clin. Pharmacol. 34, 82-84 (1992).
9. Scott AK. Sumatriptan clinical pharmacokinetics. Clin. Pharmacokinet. 27, 337-344 (1994).
10. Blier P, Bergeron R. The safety of concomitant use of sumatriptan and antidepressant treatments. J. Clin. Psychopharmacol. 15, 106-109 (1995).
11. Leung M. Lack of an interaction between sumatriptan and selective serotonin reuptake inhibitors Headache 35, 488-489 (1995).
12. Cady RK, Wendt JK, Kirchner JR, Sargent JD, Rothrock JF, Skaggs H Jr. Treatment of acute migraine with subcutaneous sumatriptan. JAMA 265, 2831-2835 (1991).
13. The Subcutaneous Sumatriptan International Study Group. Subcutaneous sumatriptan in the acute treatment of migraine. N. Engl. J. Med. 325, 316-321 (1991).
14. The Sumatriptan Cluster Headache Study Group. Treatment of acute cluster headache with sumatriptan. N. Engl. J. Med. 325, 322-326 (1991).
15. Ekbom K, Monstad I, Prusinski A, Cole JA, Pilgrim AJ, Noronha D. Subcutaneous sumatriptan in the acute treatment of cluster headache: a dose comparison study. The Sumatriptan Cluster Headache Study Group. Acta Neurol. Scand. 88, 63-69 (1993). (Pubitemid 23210979)
16. Burstein R, Collins B, Jakubowski M. Defeating migraine pain with triptans: a race against the development of cutaneous allodynia. Ann. Neurol. 55, 19-26 (2004). (Pubitemid 38067357)
17. Burstein R, Jakubowski M. Analgesic triptan action in an animal model of intracranial pain: a race against the development of central sensitization. Ann. Neurol. 55, 27-36 (2004). (Pubitemid 38067358)
18. Diamond S, Freitag FG, Feoktistov A, Nissan GR. Sumatriptan 6 mg subcutaneous as an effective migraine treatment in patients with cutaneous allodynia who historically fail to respond to oral triptans. J. Headache Pain 8, 13-18 (2007). (Pubitemid 46443508)
19. Linde M, Mellberg A, Dahlof C. Subcutaneous sumatriptan provides symptomatic relief at any pain intensity or time during the migraine attack. Cephalalgia 26, 113-121 (2006).
20. Freitag F. Diamond S, Diamond M, Urban G, Pepper B. Subcutaneous sumatriptan in patients treated with monoamine oxidase inhibitors and other prophylactic agents. Headache Q. 9, 165-171 (1998). (Pubitemid 28312044)
21. Fox AW. Subcutaneous sumatriptan pharmacokinetics: delimiting the monoamine oxidase inhibitor effect. Headache 50, 249-255 (2010).
22. MacIntyre PD, Bhargava B, Hogg KJ, Gemmill JD, Hillis WS. Effect of subcutaneous sumatriptan, a selective 5HT1 agonist, on the systemic, pulmonary, and coronary circulation. Circulation 87, 401-405 (1993). (Pubitemid 23040908)
23. Newman CM, Starkey I, Buller N et al. Effects of sumatriptan and eletriptan on diseased epicardial coronary arteries. Eur. J. Clin. Pharmacol. 61, 733-742 (2005). (Pubitemid 41674259)
24. Dodick DW, Martin VT, Smith T, Silberstein S. Cardiovascular tolerability and safety of triptans: a review of clinical data. Headache 44(Suppl. 1), S20-S30 (2004). (Pubitemid 38685542)
25. Evans RW. The FDA alert on serotonin syndrome with combined use of SSRI or SNRI and triptans: an analysis of 29 case reports. MedGenMed 9, 48 (2007).
26. Wenzel RG, Tepper S, Korab WE, Freitag F. Serotonin syndrome risks when combining SSRI/SNRI drugs and triptans: is the FDA's alert warranted? Ann. Pharmacother. 42, 1692-1696 (2008).
27. Linn L, Boyd B, Iontchev H, King T, Farr SJ. The effects of system parameters on in vivo administration performance of a needle-free injector in humans. Pharm. Res. 24, 1501-1507 (2007). (Pubitemid 46988216)
28. Brandes JL, Cady RK, Freitag FG et al. Needle-free subcutaneous sumatriptan (Sumavel™ DosePro™): bioequivalence and ease of use. Headache 49, 1435-1444 (2009).
29. Freidank-Mueschenborn E, Fox AW. Resolution of concentration-response differences in onset of effect between subcutaneous and oral sumatriptan. Headache 45(6), 632-637 (2005). (Pubitemid 40798683)