PMID- 28176235
OWN - NLM
STAT- MEDLINE
DCOM- 20170322
LR  - 20220317
IS  - 1129-2377 (Electronic)
IS  - 1129-2369 (Print)
IS  - 1129-2369 (Linking)
VI  - 18
IP  - 1
DP  - 2017 Dec
TI  - Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg 
      subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of 
      rapidly-escalating attacks of episodic migraine.
PG  - 17
LID - 10.1186/s10194-016-0717-7 [doi]
LID - 17
AB  - BACKGROUND: A 6-mg dose of SC sumatriptan is the most efficacious and fast-acting 
      acute treatment for migraine, but a 3-mg dose of SC sumatriptan may improve 
      tolerability while maintaining efficacy. METHODS: This randomized, double-blind, 
      crossover study compared the efficacy and tolerability of 3 mg subcutaneous (SC) 
      sumatriptan (DFN-11) with 6 mg SC sumatriptan in 20 adults with 
      rapidly-escalating migraine attacks. Eligible subjects were randomized (1:1) to 
      treat 1 attack with DFN-11 and matching placebo autoinjector consecutively or 2 
      DFN-11 autoinjectors consecutively and a second attack similarly but with the 
      alternative dose (3 mg or 6 mg). RESULTS: The proportions of subjects who were 
      pain-free at 60 min postdose, the primary endpoint, were similar following 
      treatment with 3 mg SC sumatriptan and 6 mg SC sumatriptan (50% vs 52.6%, 
      P  =  .87). The proportions of subjects experiencing pain relief (P  >/=  .48); 
      reductions in migraine pain intensity (P  >/=  .78); and relief from nausea, 
      photophobia, or phonophobia (P  >/=  .88) with 3 mg SC sumatriptan and 6 mg SC 
      sumatriptan were similar, as were the mean scores for satisfaction with treatment 
      (M  =  2.6 vs M  =  2.4, P  =  .81) and the mean number of rescue medications 
      used (M  =  .11 vs M  =  .26, P  =  .32). The most common adverse events with the 
      3- and 6-mg doses were triptan sensations - paresthesia, neck pain, flushing, and 
      involuntary muscle contractions of the neck - and the incidence of adverse events 
      with both doses was similar (32 events total: 3 mg, n  =  14 [44%]; 6 mg, 
      n  =  18 [56%], P  =  .60). Triptan sensations affected 4 subjects with the 6-mg 
      dose only, 1 subject with the 3-mg dose only, and 7 subjects with both 
      sumatriptan doses. Chest pain affected 2 subjects (10%) treated with the 6-mg 
      dose and no subjects (0%) treated with the 3-mg dose of DFN-11. There were no 
      serious adverse events. CONCLUSIONS: The 3-mg SC dose of sumatriptan in DFN-11 
      provided relief of migraine pain and associated symptoms comparable to a 6-mg SC 
      dose of sumatriptan. Tolerability was similar with both study medications; DFN-11 
      treatment was associated with fewer triptan sensations than the 6-mg dose. 
      DFN-11, with its 3-mg dose of sumatriptan, may be a clinically useful alternative 
      to higher-dose autoinjectors.
FAU - Cady, Roger K
AU  - Cady RK
AD  - Clinvest/A Division of Banyan Inc., 3805 S Kansas Expy, Springfield, MO, 65807, 
      USA.
FAU - Munjal, Sagar
AU  - Munjal S
AD  - Dr. Reddy's Laboratories Ltd., 107 College Road East, Princeton, NJ, 08540, USA.
FAU - Cady, Ryan J
AU  - Cady RJ
AD  - Clinvest/A Division of Banyan Inc., 3805 S Kansas Expy, Springfield, MO, 65807, 
      USA. ryancady@clinvest.com.
FAU - Manley, Heather R
AU  - Manley HR
AD  - Clinvest/A Division of Banyan Inc., 3805 S Kansas Expy, Springfield, MO, 65807, 
      USA.
FAU - Brand-Schieber, Elimor
AU  - Brand-Schieber E
AD  - Dr. Reddy's Laboratories Ltd., 107 College Road East, Princeton, NJ, 08540, USA.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170207
PL  - England
TA  - J Headache Pain
JT  - The journal of headache and pain
JID - 100940562
RN  - 0 (Serotonin 5-HT1 Receptor Agonists)
RN  - 8R78F6L9VO (Sumatriptan)
SB  - IM
MH  - Adult
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Migraine Disorders/*drug therapy
MH  - *Outcome Assessment, Health Care
MH  - Pilot Projects
MH  - Serotonin 5-HT1 Receptor Agonists/*administration & dosage/adverse 
      effects/*pharmacology
MH  - Sumatriptan/*administration & dosage/adverse effects/*pharmacology
MH  - Young Adult
PMC - PMC5296269
OTO - NOTNLM
OT  - Episodic
OT  - Migraine
OT  - Rapidly-escalating
OT  - Subcutaneous
OT  - Sumatriptan
OT  - Treatment
EDAT- 2017/02/09 06:00
MHDA- 2017/03/23 06:00
PMCR- 2017/02/07
CRDT- 2017/02/09 06:00
PHST- 2016/12/03 00:00 [received]
PHST- 2016/12/21 00:00 [accepted]
PHST- 2017/02/09 06:00 [entrez]
PHST- 2017/02/09 06:00 [pubmed]
PHST- 2017/03/23 06:00 [medline]
PHST- 2017/02/07 00:00 [pmc-release]
AID - 10.1186/s10194-016-0717-7 [pii]
AID - 717 [pii]
AID - 10.1186/s10194-016-0717-7 [doi]
PST - ppublish
SO  - J Headache Pain. 2017 Dec;18(1):17. doi: 10.1186/s10194-016-0717-7. Epub 2017 Feb 
      7.