Axsome Therapeutics, Inc., a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, has officially published results from its EMERGE Phase 3 trial of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) in patients experiencing inadequate response to oral CGRP inhibitors.
Going by the available details, SYMBRAVO happens to be a novel, oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults.
The drug includes MoSEIC™ meloxicam and rizatriptan to deliver on its promised value. In case you weren’t aware, Meloxicam is a new molecular entity, designed for migraine and enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology. For better understanding, this particular technology allows for the rapid absorption of Meloxicam, while simultaneously maintaining a long plasma half-life.
More on the given formulation would reveal how Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID), whereas on the other hand, rizatriptan would be a 5-HT1B/1D agonist.
“We’re pleased to share the results of the Phase 3 EMERGE trial, which further underscore the robust efficacy of SYMBRAVO and its potential to effectively treat migraine attacks across a range of patient populations with varying pain intensities and prior responses to acute treatments. We look forward to launching SYMBRAVO in the U.S. in the coming months,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics,
Talk about the given trial’s results on a slightly deeper level, it used Migraine Treatment Optimization Questionnaire (mTOQ-4) to reveal that the drug successfully met its primary endpoint, with SYMBRAVO demonstrating statistically significantly greater migraine treatment response compared to oral CGRP inhibitors.
Named as EMERGE, the relevant trial was an open-label study which enrolled migraine patients undergoing treatment with an oral CGRP inhibitor for at least one month and were found to be experiencing an inadequate response to the oral CGRP inhibitor.
In total, the study recruited 96 patients, and the number of migraine attacks it would go on treat with SYMBRAVO would settle around 365.
According to certain reports, all the enrolled patients were switched to treatment with SYMBRAVO for their next four attacks. Once that bit was done, treatment responses after the oral CGRP inhibitor treatment period and after the SYMBRAVO treatment period were pitted against each other.
The results had SYMBRAVO showcasing statistically significantly greater migraine treatment response among the SYMBRAVO contingent when compared to treatment response with prior oral CGRP inhibitors (5.2 versus 2.8, p<0.001). Almost like an extension of that, significantly greater proportions of patients achieved clinical response on the 2-hour pain freedom, sustained pain freedom, ability to return to normal activities, and ability to plan daily activities mTOQ-4 items with SYMBRAVO.
We get to say so because pain freedom within 2 hours for most attacks was reported half the time or more by 47.9% of patients after treatment with SYMBRAVO, compared to 1.0% of patients after treatment with oral CGRPs (p<0.001).
Next up, sustained relief of migraine pain, for at least 24 hours following a single dose of medication, was reported half the time or more by 47.9% of patients after treatment with SYMBRAVO, compared to 16.7% of patients after treatment with oral CGRPs (p<0.001).
If we discuss the ability to quickly return to normal activities after taking their medication, it was reported as half the time or more by 51.0% of patients after treatment with SYMBRAVO, compared to 11.5% of patients after treatment with oral CGRPs (p<0.001).
Turning our attention towards proportion of patients who reported being comfortable enough with their medication to be able to plan daily activities, it was deemed as 63.5% big after treatment with SYMBRAVO, compared to 26.0% after treatment with oral CGRPs (p<0.001).
“The results of the EMERGE study demonstrate significant improvements in migraine treatment response with SYMBRAVO for patients previously experiencing inadequate response to oral CGRPs based on the mTOQ-4. Migraine is a disabling neurological condition, and the multiple mechanisms of action of SYMBRAVO may be relevant to the complex and heterogenous nature of this serious condition.” said Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine.
