Efficacy

Efficacy of Ajovy (fremanezumab-vfrm) for Migraine

Ajovy (fremanezumab-vfrm) is a monoclonal antibody that has been approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults. It works by targeting and blocking the activity of the calcitonin gene-related peptide (CGRP), a molecule involved in migraine attacks. Clinical trials have demonstrated that Ajovy can significantly reduce the monthly average number of migraine days. Patients receiving Ajovy in these studies reported fewer migraine days per month compared to those on placebo. The efficacy of Ajovy was observed as early as the first month of treatment and was sustained over the trial period.

The pivotal trials for Ajovy included two Phase 3 studies: HALO CM and HALO EM. In the HALO CM study, which involved patients with chronic migraine, Ajovy reduced the average number of headache days of at least moderate severity by 4.6 days per month for the quarterly dosing and by 4.3 days per month for the monthly dosing, compared to 2.5 days with placebo. In the HALO EM study, which involved patients with episodic migraine, those on Ajovy experienced a reduction of 3.7 headache days per month for the quarterly dosing and 3.4 days for the monthly dosing, versus 2.2 days with placebo.

Efficacy of Trudhesa (dihydroergotamine mesylate) for Migraine

Trudhesa (dihydroergotamine mesylate) is a nasal spray indicated for the acute treatment of migraine with or without aura in adults. Dihydroergotamine mesylate (DHE) is a well-established migraine treatment that has been used for decades. Trudhesa utilizes a proprietary nasal delivery system designed to improve the absorption and bioavailability of DHE. Clinical studies have shown that Trudhesa can provide rapid relief from migraine symptoms, with some patients experiencing relief within 2 hours after administration. The efficacy of Trudhesa is attributed to its ability to deliver DHE effectively to the systemic circulation, bypassing the gastrointestinal tract, which can be beneficial during a migraine attack when gastric stasis may occur.

In clinical trials, Trudhesa demonstrated a significant improvement in pain relief and other migraine-associated symptoms such as nausea and sensitivity to light and sound, compared to placebo. The treatment was generally well-tolerated, and the most common adverse reactions were typical of DHE, including nasal congestion, nausea, and vomiting. The unique delivery system of Trudhesa allows for consistent dosing and has the potential to offer an effective alternative for patients who require fast-acting relief from migraine attacks.