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.

*SUMAVEL and DosePro are registered trademarks of Zogenix Inc., Emeryville and San Diego, CA, USA.

Research design and 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).

Clinical trial registration number:

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.

Conclusion:

With SDP, triptan users requiring a change in therapy experienced increased efficacy, satisfaction with therapy, and confidence in treatment without deterioration in tolerability.

Keywords::

• 5HT_1B/1D agonist
• Headache
• Injection
• Migraine
• Satisfaction
• Sumatriptan
• Triptan

Transparency

Declaration of funding

The study described in this manuscript was funded by Zogenix Inc.

Declaration of financial/other relationships

Within the past year, J.F.R. has disclosed that he received funding for investigator-initiated or collaborative clinical research from GlaxoSmithKline, Merck and Zogenix. He actively serves as a consultant to Allergan and within the past year has served on physicians’ advisory boards for Allergan, Zogenix, MAPP, and Nautilus. He is an active member of the speakers’ bureaus for Allergan, Merck, Zogenix and GlaxoSmithKline. R.K.C. has disclosed that he served as a consultant, served on the advisory board, received honoraria, and received research grants or funds for studies from Zogenix and has served as a consultant, served on the advisory board, received honoraria, and/or received research grants or funds for studies for the following companies: Advanced Neuromodulation, Allergan, Astellas, AstraZeneca, Boston Scientific, Endo Pharmaceuticals, Inc., GlaxoSmithKline, Johnson & Johnson, KOWA Pharmaceuticals, MAP Pharmaceuticals, Merck & Company, Inc., Minster Pharmaceuticals, Nautilus Neuroscience, NuPathe, Ortho-McNeil Neurologies, Prometheus Labs, Puramed BioScience, Wyeth. S.K.A. has disclosed that she has received compensation from Zogenix and other pharmaceutical companies for activities including consulting fees/honoraria and research funds. J.L.B. has disclosed that she has received speaker fees for activities with Merck, GlaxoSmithKline, Allergan, Endo, Zogenix/Astellas, and Nautilus. She has also received research grants and support from Merck, GlaxoSmithKline, Pfizer, AstraZeneca, Allergan, Zogenix/Astellas, Boston Scientific, Johnson & Johnson, Eli Lilly, MAP Pharmaceuticals, NuPathe, Sanofi-Aventis, Bristol-Myers Squibb, and Novartis. She serves as a consultant for Merck, Allergan, and Nautilus. A.W.F. serves as a consultant to Zogenix. J.A.M. and S.J.F. have disclosed that they are employed by Zogenix.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors acknowledge Cynthia Robinson, PhD (Zogenix, Inc.) and Synteract Inc., Carlsbad, California USA for various responsibilities relating to study management and Good Clinical Practices compliance, and especially Heather Bentley (Clinical Study Manager), Carol Wong, PhD (Biostatistician), and Roya Hooshmand-Rad, MD, PhD (Medical Monitor). The authors acknowledge Jane Saiers, PhD (The WriteMedicine, Inc.) for assistance with writing the manuscript.

Notes

*SUMAVEL and DosePro are registered trademarks of Zogenix Inc., Emeryville and San Diego, CA, USA.

*SUMAVEL and DosePro are registered trademarks of Zogenix Inc., Emeryville and San Diego, CA, USA.