The primary efficacy endpoint was the mean change from baseline in the monthly average number of headache days of at least moderate severity during the 3-month treatment period.
The label includes a Boxed Warning describing the risk of hepatotoxicity associated with APAP. Most cases of liver injury were associated with APAP doses >4000mg daily and often involved >1 APAP-containing product.
The efficacy of Aimovig was evaluated as a preventive treatment of episodic or chronic migraine in 3 randomized, double-blind, placebo-controlled studies: 2 studies in patients with episodic migraine (4-14 migraine days per month) and 1 study in patients with chronic migraine (≥15 headache days per month with ≥8 migraine days per month).
DFN-02 was evaluated in a multicenter, double-blind, randomized, placebo-controlled study (N=107) which showed it was effective in treating pain and associated symptoms during a migraine attack and in reducing attack-related functional disability.
Aimovig is a fully human monoclonal antibody, designed to selectively block the calcitonin gene-related peptide (CGRP) receptor.
The researchers found that, compared to placebo, galcanezumab (120mg) significantly reduced migraine headache days (99.6% posterior probability, −4.8 days).
Zecuity, launched in September 2015, is a transdermal system that delivers a therapeutic dose via a single-use, battery-powered patch wrapped around the upper arm or thigh.
The non-invasive SpringTMS device is placed at the back of the patient's head where a forced magnetic pulse is delivered to treat an acute attack or to prevent a future migraine onset.