New Drug Product: Ajovy
This slideshow reviews drug information for Ajovy. Click here for the complete Ajovy new product monograph. For a downloadable PDF of this slideshow, click here.
Migraine
Ajovy Injection Approved for Migraine Prevention in Adults
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.
Butalbital/APAP Capsules Launched for Complex Tension Headache
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.
First-of-its-Kind Migraine Drug Gets FDA Approval
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).
Novel Nasal Spray for Migraine Attacks to Be FDA Reviewed
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.
Migraine Treatment With Needle-Free Delivery System No Longer Available
Both strengths of Sumavel DosePro have now been discontinued.
Erenumab Effective in Migraine Patients With Multiple Treatment Failures
Aimovig is a fully human monoclonal antibody, designed to selectively block the calcitonin gene-related peptide (CGRP) receptor.
Monthly Galcanezumab Beneficial for Episodic Migraine Prevention
The researchers found that, compared to placebo, galcanezumab (120mg) significantly reduced migraine headache days (99.6% posterior probability, −4.8 days).
Migraine Patch Product No Longer Available
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.
BLA Submitted for Migraine Prevention Drug Fremanezumab
The studies looked at the safety, tolerability, and efficacy of 4 dose regimens of subcutaneous fremanezumab vs. placebo over 16 weeks.
