Dr. Cady continued, “The Phase 4 study results confirm that SUMAVEL DosePro can be an important component of a migraine patient’s therapeutic toolbox. I believe it is important for physicians to provide their patients with treatment options to help manage the variety of attacks that patients experience.”
In a Phase 4 open-label, multicenter U.S. study more than 200 adult patients diagnosed with migraine and taking triptan therapy were enrolled to evaluate overall satisfaction, confidence and preference for SUMAVEL DosePro, as well as efficacy and safety, in treating multiple migraine attacks. Key results from the study include:
- Patients reported greater overall satisfaction after treating multiple migraine attacks with SUMAVEL DosePro compared to their current triptan therapy, which was predominantly oral triptans
- Freedom from pain was achieved in 61% of migraine episodes within 2 hours
- In 33% of migraine episodes, pain relief was achieved in 15 minutes; in 70% of episodes it was achieved in 30 minutes; and in 85% and 86% of episodes it was achieved in 1 and 2 hours
- A subset of patients (90) identified as needing a change in their migraine therapy based on their Migraine Assessment of Current Therapy (Migraine-ACT) score showed dramatic improvements in treatment satisfaction after using SUMAVEL DosePro
- Patients showed a clinically relevant improvement in overall treatment satisfaction (from 17% at baseline to 62%) and confidence (from 22% at baseline to 58%) by the end of the treatment period
- Provided effective relief from migraine pain and associated symptoms
- Efficacy, satisfaction and confidence remained consistent during use for multiple migraine attacks
By including SUMAVEL DosePro as a treatment option, which currently represents less than 5% of the triptan prescriptions, these patients can access:
- Migraine pain relief beginning within 10 minutes for some patients*
- First-of-its-kind needle-free delivery system providing injectable sumatriptan option when oral therapies may be an impractical treatment option (i.e. migraine with vomiting or nausea)
- An alternative for patients with rapid onset migraines because subcutaneous sumatriptan delivery is quickly absorbed
Roger Hawley, Chief Executive Officer of Zogenix, concluded, "Our mission at Zogenix is simple and clear. We are passionately striving to make a difference for patients with moderate to severe migraine attacks through education and by offering a unique way to treat migraines. We believe that SUMAVEL DosePro fills a significant unmet medical need for migraine patients and has the potential to provide economic benefits for employers who are paying the high costs from ineffective treatments and the corresponding loss of productivity."*In two well-controlled clinical trials (N=1104) with patients experiencing moderate or severe pain and one or more migraine symptoms, the efficacy of subcutaneous sumatriptan vs. placebo was evaluated. In these clinical trials, 16% of patients achieved relief within 10 minutes vs. 4% placebo; 70% of patients achieved relief at one hour vs. 22% placebo; and 82% of patients achieved relief at two hours vs. 39% placebo. (1) American Migraine Foundation; http://www.americanmigrainefoundation.org/whatismigraine.aspx#burden. (2) National Migraine Treatment Survey on behalf of the National Headache Foundation, March 2010. About SUMAVEL DosePro SUMAVEL DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
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