Patients with difficult-to-treat migraine headaches showed improved treatment response using adhesive dermally applied microarray (ADAM) zolmitriptan 3.8 mg compared with patients using a placebo, according to a study published in Headache.
Researchers completed a post hoc analysis of the randomized, double-blind, placebo-controlled ZOTRIP clinical trial (NCT02745392) data to assess if symptoms of difficult-to-treat migraine headaches affected the efficacy of ADAM zolmitriptan 3.8 mg. Patients who experience 2 to 8 migraine headaches over a 28-day period were randomly assigned to either a placebo arm or 1 of 3 arms with different dosages of ADAM zolmitriptan. An e-diary was used to record migraine indicators, such as
- pain onset,
- pain freedom, and
- waking with headache pain.
Of the 365 patients included, 321 were classified as having difficult-to-treat migraine headaches. Of this subset, 77 were in the placebo arm and 82 were in the ADAM zolmitriptan 3.8 mg arm. When comparing these 2 arms, the ADAM zolmitriptan 3.8 mg arm had more patients who experienced moderate pain with migraine headaches with pain freedom 2 hours post-treatment, more patients with freedom from their most bothersome associated symptom 2-hours post-treatment, and more patients without recurrence of pain at both 24 and 48 hours after treatment. These findings were true for patients experiencing nausea, waking with migraine pain, and patients who treated their headaches more than 2 hours after onset.
Limitations of this study include the sample size being too small and statistical power being limited to accurately assess treatment efficacy in this post hoc analysis.
The researchers concluded, “participants receiving ADAM zolmitriptan 3.8 mg displayed nearly uniformly better headache responses (2-hour headache freedom and 2-hour [most bothersome associated symptom] freedom) compared with those who received placebo.”
This study was supported by Zosano Pharma Corporation and authors report multiple associations with pharmaceutical companies. Please see the original reference for a full list of authors’ disclosures.
Tepper SJ, Dodick DW, Schmidt PC, Kellerman DJ. Efficacy of ADAM zolmitriptan for the acute treatment of difficult-to-treat migraine headaches [published online January 30, 2019]. Headache. doi: 10.1111/head.13482