An Eli Lilly drug developed to stop migraine headaches before they can start hit its main goals in a late-stage clinical trial, the company said Friday. With those results now in hand, the Indianapolis-based drugmaker plans to file for FDA approval of the drug later this year.
Eli Lilly tested its drug galcanezumab in three Phase 3 clinical trials enrolling patients who experienced episodic and chronic migraine headaches. Patients were randomized to receive either the Lilly drug or a placebo. The injectable drug did not stop migraines from developing entirely. But in the three-month treatment period, Lilly says that patients given its drug experienced fewer headaches per month compared to the group that received a placebo—enough to show statistical significance.
Lilly says its drug beat a placebo at both the 120 mg and the 240 mg doses. The most common adverse events were reactions at the site of the injection.
Lilly’s clinical trial results give additional validation for a new approach to migraine treatment. For decades, the first-line migraine drugs treated pain after symptoms start. These drugs, called triptans, reduce inflammation and constrict blood vessels. Lilly’s galcanezumab is part of a new class of drugs that work in a different way, interfering with a protein called calcitonin gene-related peptide (CGRP). This protein, which is released by neurons, is thought to play a role in transmitting pain. By blocking this protein, researchers aim to stop the onset of migraine pain.
Check out the full article here: Eli Lilly Migraine Drug Hits Study Goals, Paves Way for FDA Filing
Welcome to Clinical Research Trends, a new blog dedicated to providing breaking news on clinical trial recruitment, patient engagement, new technology and noteworthy trends. With this blog, we are working to provide clinical research organizations, sponsors and leading service providers with critical news and industry updates on a regular basis. If you want to learn more about the latest trends in clinical trial recruitment and drug development, you’ve come to the right place.