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Migraine Patch Meets Primary Goals in Late-Stage Study
M207 (Zosano Pharma Corporation) has achieved the coprimary endpoints of freedom from migraine pain and freedom from the most bothersome symptom of migraine at two hours in a pivotal phase 3 trial. M207 is a proprietary zolmitriptan-coated microneedle patch that delivers subcutaneous zolmitriptan during a migraine attack.
The multicenter, double-blind, randomized, placebo-controlled, dose-ranging ZOTRIP trial compared three doses of M207 (1.0 mg, 1.9 mg, and 3.8 mg) with placebo for a single migraine attack. A total of 589 subjects were enrolled at 36 sites in the United States. Of these individuals, 321 qualified for the modified intent-to-treat population. During a migraine, subjects scored the severity of pain on a four-point scale, and the presence or absence of migraine-associated symptoms (i.e., photophobia, phonophobia, or nausea), starting pre-dose and then at several intervals during 48 hours post-dose.
The highest dose of M207 (3.8 mg) achieved significance in the secondary endpoints of pain freedom at 45 minutes and one hour, and showed a durable affect on pain freedom at 24 and 48 hours. The key findings were as follows:
- 42% of treated patients experienced freedom from pain at two hours compared with 14% of the placebo group (P < 0.0001).
- 68% of treated patients experienced freedom from the most bothersome symptom of migraine at two hours compared with 43% of the placebo group (P < 0.0009).
- 27% of treated patients experienced freedom from pain at one hour compared with 10% of the placebo group (P < 0.0084).
M207 was well tolerated, with no serious adverse events.
- Thirteen patients (4%) reported pain at the application site.
- The most frequently reported adverse event was redness at the application site (18% of subjects). All cases of redness resolved.
- Five (2%) patients reported dizziness compared with no patients in the placebo group.
According to the American Migraine Association, migraine is the leading cause of disability among neurological disorders in the U.S. An estimated 36 million American adults experience migraine. The disorder can be disabling and costly, accounting for more than $20 billion in direct and indirect medical expenses each year in the U.S. Direct expenses include doctor visits and medications, and indirect expenses include missed work and lost productivity.
Source: Zosano Pharma; February 13, 2017.