M207 Clinical Data
The pharmacokinetics of zolmitriptan delivery using ADAM were evaluated in a Phase 1, open-label, ascending dose study in healthy volunteers (N=20).1 For M207 (zolmitriptan intracutaneous microneedle system) 3.8 mg, the median time to maximum concentration was 15 minutes (comparable to subcutaneously administered sumatriptan). Absorption was substantially faster than for oral zolmitriptan, with higher exposure in the first two hours. Adverse events were predominantly mild (87%) and of a short (<24 hour) duration. The most common adverse events (≥10%) were paresthesia; headache; throat and jaw tightness, heaviness, ache; hot flushes; and upper respiratory tract infection.
Clinical Efficacy and Safety
A randomized, double-blind, multi-center, parallel-group clinical trial (N=365) was conducted to evaluate the efficacy and safety of M207 for acute migraine (with or without aura) treatment in adults. Patients selected their most bothersome headache-associated symptom (MBS) from among photophobia, phonophobia, and nausea. The primary endpoints of the trial were the proportion of patients who were pain-free or MBS-free two hours following treatment with M207. The M207 3.8 mg dose was significantly superior to placebo for both of the primary endpoints.
Data from the mITT population. LOCF for missing data. Placebo groups pooled. Pain-free defined as a value of 0 on a scale of 0-3
Nearly 32% of patients were pain-free from 2 hours through 24 hours, and 27% had sustained pain freedom for 48 hours.
*Nominal P-value. Data from the mITT population. LOCF for missing data. Placebo groups pooled.
Adverse events occurred in 52% of the patients in M207 treatment group and 18% of those who received placebo. Most adverse events were considered mild. The most common were application site erythema, application site bruising, application site pain, and application site bleeding.
For more information on this clinical trial please visit www.clinicaltrials.gov (NCT02745392).
ADAM zolmitriptan is an investigational product not approved by FDA