15 Dec Products in the Pipeline: Migraine Drugs Show Promise but Advance Slowly
Medications to prevent migraine have been slow in coming, but a treatment approach currently being studied suggests that a new type of drug may benefit countless migraineurs. This new method employs agents that block a protein called calcitonin gene-related peptide (CGRP), which plays a crucial role in migraine. The new drugs, anti-CGRP antibodies, bind to the protein and stop it from attaching to nerve receptors, preventing migraine in the process.
The results of 2 phase-2 trials, published in The Lancet this fall, were promising. The first study showed that after 3 months the injectable drug LY2951742 decreased headache by more than 4 days per month as compared with 3 days for those receiving placebo. A study published last month showed that intravenous administration of the agent ALD403 reduced headache days in weeks 5 to 8 of the study by 5.6 for the group receiving treatment compared with 4.6 in the placebo group.
Study participants were followed for 6 months, and no participants experienced serious adverse effects related to the drugs. The authors noted that the drugs are at least 5 years away from being available. Both studies were led by David Dodick, MD, of the Mayo Clinic in Scottsdale, Arizona.
In other migraine medication news, the U.S. Food and Drug Administration (FDA) did not approve AVP-825, a device that delivers a low dose of sumatriptan powder into the nose. The FDA requested some modifications to what is called the “user interface,” which includes the packaging and patient instructions for use, and requested an additional study be done to evaluate use-related risks and confirm that patients can use the device safely and effectively.
OptiNose, which developed the device and was hoping for approval last month, is pressing ahead and hopes to respond to the FDA’s concerns next year, according to Peter Miller, Chief Executive Officer of the company.
“In tandem with our partner Avanir, we believe the issue raised by the FDA is fully addressable and have already begun efforts to complete the necessary work,” he said. “Together, we are well-positioned to rapidly address the human factor concern and plan to respond to the FDA in the first half of 2015… . Once approved, we believe the product will be an important new treatment option for patients with migraine headaches looking for an innovative, fast acting, well-tolerated solution.”