title: Needle-free subcutaneous sumatriptan for triptan users requiring a change in migraine therapy: efficacy and impact on patient-rated functionality, satisfaction, and confidence.
abstract: OBJECTIVE
  To evaluate efficacy of, satisfaction with, and confidence in SDP (SUMAVEL DosePro *) among triptan users requiring a change in therapy. SDP is a needle-free, subcutaneous sumatriptan product that confers relief as early as 10 minutes postdose.
  
  
  METHODS
  In an open-label study, SDP was administered for ≤4 migraine attacks over ≤60 days by migraineurs currently treated with triptans (any form/dosage). In the 90 patients with baseline Migraine-ACT scores ≤2 (indicating the need for a change in therapy), efficacy data were collected from patient diaries, and satisfaction was measured with the revised Patient Perception of Migraine Questionnaire (PPMQ-R).
  
  
  BACKGROUND
  NCT01016834 on clinicaltrials.gov.
  
  
  RESULTS
  Across all attacks, the rates of pain relief were 30.7%, 66.4%, 80.1%, 81.6%, and 77.6% at 0.25, 0.5, 1, 2, and 24 hours postdose, respectively. Corresponding results for pain-free response were 0.7%, 14.8%, 35.0%, 48.0, and 65.7%. Sustained 24-hour pain relief was observed in 61.0% of attacks. PPMQ-R scores (transformed to 0-100 scales, mean ± SD) improved from baseline to end of treatment for Efficacy (52.5 ± 17.8 versus 74.8 ± 23.4, p < 0.0001) and Functionality (46.2 ± 22.3 versus 71.3 ± 25.2, p < 0.0001) with no deterioration in Tolerability (80.6 ± 14.7 versus 83.5 ± 17.7, p = 0.12). PPMQ-R Overall Satisfaction score increased from baseline to end of treatment (55.1 ± 23.2 versus 74.6 ± 27.7, p < 0.0001). The percentage of patients (90% confidence interval) confident or very confident in treating migraine attacks increased from 22.2% (15.2, 30.6) at baseline to 57.8% (48.6, 66.6) at end of treatment. Results should be interpreted in the context of the open-label design of the original study.
  
  
  CONCLUSIONS
  With SDP, triptan users requiring a change in therapy experienced increased efficacy, satisfaction with therapy, and confidence in treatment without deterioration in tolerability.
authors.affiliation: The University of Alabama School of Medicine, Birmingham, AL, USA.
authors.forename: John F
authors.initials: JF
authors.lastname: Rothrock
authors.forename: Roger K
authors.initials: RK
authors.lastname: Cady
authors.forename: Sheena K
authors.initials: SK
authors.lastname: Aurora
authors.forename: Jan Lewis
authors.initials: JL
authors.lastname: Brandes
authors.forename: Judith A
authors.initials: JA
authors.lastname: Myers
authors.forename: Anthony W
authors.initials: AW
authors.lastname: Fox
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Farr
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004333:Drug Administration Routes; D016503:Drug Delivery Systems / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D017060:Patient Satisfaction; D058825:Serotonin 5-HT1 Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use; D018170:Sumatriptan / Q000008:administration & dosage* / Q000627:therapeutic use*; D016896:Treatment Outcome; D014363:Tryptamines / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D058825:Serotonin 5-HT1 Receptor Agonists; D014363:Tryptamines; D018170:Sumatriptan