People with migraine disease have seen more positive developments in the last three years than we’ve seen in decades, with new classes of preventive and acute treatments, new devices, increased public awareness and support, and more research and development. Although many people with migraine have experienced greater relief through these breakthroughs, many more are still waiting for treatments that work for them.

 

The good news is that more promising advancements are on the horizon, including new medications, new delivery systems to make existing medications more effective, and devices that don’t use medication at all. Here’s a look at some of the developments on the horizon in 2021:

 

MEDICATIONS

 

Gepants: Gepants, like the CGRP monoclonal antibodies used as preventive medications, block the action of the CGRP protein that plays a big role in the migraine process. Unlike the preventives, however, these acute treatments are small molecules that can block CGRP receptors without requiring injection. Because they do not constrict blood vessels, they may help people whose cardiac or vascular risks prevent them from using triptans, which do constrict blood vessels.¹ Gepants are currently only FDA-approved as acute treatment, however, they are now being studied for use as preventive treatments, potentially helping those who haven’t found the CGRP monoclonal antibodies effective or who prefer oral formulations over injections.

 

One of the gepants we are watching is Biohaven’s zavegepant. The company’s first acute oral migraine medication, rimegepant (brand name Nurtec ODT) has been effective for many patients in its first year on the market. Under study in nasal spray and oral formulations, zavegepant performed well as an acute migraine medication in a Phase 2/3 clinical trial with significant benefit demonstrated on freedom from pain and most bothersome symptoms at two hours after dosing. It also produced rapid onset with pain relief at 15 minutes (10 and 20mg) and  return to normal function as early as 30 minutes (20mg). ²

The surprising development here is zavegepant’s possible benefit for indications other than migraine—including the COVID-19 virus.  In April 2020, the FDA granted Biohaven permission to begin a Phase 2 clinical study of zavegepant’s potential use in mitigating an excessive immune response, which in some cases can be fatal in COVID-19.³ Biohaven also announced last November a collaboration with Weill Cornell Medicine to initiate a proof of concept trial with CGRP receptor antagonists in plaque psoriasis.

 

Psychedelics: Although psychedelic substances are currently prohibited in the US, researchers and advocates believe that they may be effective treatments for a number of neurological conditions, including migraine disease and cluster headache disease. Researchers who want to study their use have to clear substantial legal hurdles to do so, but in this Spotlight on Migraine podcast, Dr. Franklin King from Massachusetts General Hospital’s new Center for the Neuroscience of Psychedelics explains the science behind their potential benefits.4

 

While we don’t expect to see psychedelic-based treatments on the market in 2021, the growing interest in therapeutic uses may improve the legal and cultural landscape for more substantial clinical study.

 

DELIVERY SYSTEMS

 

Several companies are working on new delivery systems for existing medications, a concept that could help millions of people with migraine disease and other conditions. Microneedle patch: Although the Qtrypta patch from Zosano Pharma needs more study before it gets FDA approval5, the concept could open the door to making existing acute medications more effective for people with a common migraine symptom.

 

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