A new small molecule calcitonin gene-related peptide (CGRP) drug in phase 3 clinical trials has shown promising relief of migraine symptoms when administered as an acute single-dose treatment. The migraine drug, Rimegepant, relieved pain and other bothersome migraine symptoms in patients who were involved in two randomized, pivotal phase 3 clinical trials of this investigational treatment.
Both randomized clinical trials demonstrated significant improvements in symptoms associated with migraine for those who received rimegepant. One of the trials involved 1,162 participants while the other trial had 1,186 participants. In both trials, patients were randomized to receive either a single dose of the drug or placebo. Based on the results, there were notable improvements in several migraine symptoms that many migraine sufferers find disabling. Symptomatic improvements were seen for those who experienced photophobia, phonophobia, nausea, and pain. In fact, many of those with migraine pain found complete relief from this potential treatment. In the two studies, pain relief was found to last from 2-24 hours after the drug was administered, while improvement of other symptoms was sustained from 2-48 hours after a dose was given (Practical Neurology, 2018).
Rimegepant was found to be generally well tolerated and may serve as a safe and effective alternative treatment option to other commonly used migraine medications, should the drug get FDA approval. In both clinical trials, nausea was the most common adverse side effect, affecting about 1.4% of patients who received the drug. The drug was also found to have a solid liver-safety profile that was similar to placebo. Rimegepant could prove to be a safe alternative migraine treatment to triptan medications, which are vasoconstrictors and pose cardiovascular risks for some (Practical Neurology, 2018).
While more research data from clinical trials is needed before Rimegepant can go through the FDA approval process, the results so far for this migraine drug are encouraging. This is a potentially highly effective and safe migraine treatment that could benefit millions who suffer from disabling migraine symptoms. We will be following the progress of this drug and will provide an update should this drug get FDA clearance.
Interested in learning more about Migraine research? Please call 561-296-3820. The Premiere Research Institute in West Palm Beach regularly conducts clinical research studies in the field of Migraines. To find out more about these studies click here or sign up for their newsletter to keep informed about the newest treatments, articles, and research that are being conducted in the field of Migraines.
Rimegepant Provides Freedom From Pain and Other Symptoms in Phase 3 Clinical Trials. Practical Neurology. (2018, July). Retrieved September 23, 2018, from http://practicalneurology.com/neurologywire/2018/07/03/rimegepant-provides-freedom-from-pain-and-other-symptoms-in-phase-3-clinical-trials