New Treatments: What’s in the Pipeline

2018 may have been a pivotal year in migraine treatment with the release of CGRP monoclonal antibodies, but that was merely the first wave of new treatments for people with migraine disease. As 2019 winds down, there are more promising treatments in the pipeline than ever before, all aiming at different targets in the migraine process. Some are new kinds of medications that may abort or prevent attacks with fewer risks than other currently available treatments. Others are neuromodulators, devices that patients can apply externally to disrupt the electrical signals during migraine attacks. 

Let’s take a look at the kinds of treatments in the pipeline and what we know about them. 

 

Ditans

Ditans are a new class of abortive medication. While triptans stop a migraine in progress by blocking several serotonin receptors in the brain, ditans block only one specific receptor. The result: they abort migraine attacks without constricting blood vessels, which makes them safer than triptans for migraine patients who also have coronary risks—a common comorbidity. They may also be helpful for the estimated two-thirds of patients who have tried triptans but don’t always get relief. 

Eli Lilly’s lasmiditan (brand name Reyvow) earned FDA approval in October 2019. Clinical trials suggest that about 30%-40% of patients had significant improvement or cessation of symptoms within two hours after a dose. Cost information is not available. The US Drug Enforcement Agency has yet to classify it, as its side effects may include sleepiness, dizziness, and possible impaired driving. This medication won’t be available until early 2020.

 

Key Points:

  • Manufacturer: Eli Lilly
  • Medication Class: Ditans
  • FDA Approval: Received in October 2019
  • Efficacy: 30-40% of patients had improvement
  • Available early 2020
  • Lasmiditan will be available as a tablet

 

Gepants

The current CGRP preventive treatments are large-molecule antibodies that don’t cross the blood-brain barrier. Gepants also target CGRP, but these small-molecule antagonists can penetrate the blood-brain barrier. They metabolize rapidly and, unlike earlier generations of similar treatments, they do not appear to cause liver problems. Researchers believe they will be effective abortive treatments with few side effects. 

Allergan’s ubrogepant and Biohaven’s rimegepant were both submitted to the FDA for approval in mid-2019. If approved, they should be on the US market by mid-2020. Clinical studies suggest that about 20% of patients were pain-free after two hours. That might not seem like an impressive result on the surface, but gepants and ditans may provide desperately needed relief for patients lacking other effective abortive treatments. Cost estimates are not yet available. 

 

Key Points:

  • Manufacturers: Allergan and Biohaven
  • Medication Class: CGRP Receptor Antagonist
  • Efficacy: 20% of patients had improvement after 2 hours
  • Should be available in 2020
  • Will be available in oral medication (Rimegepant and Ubrogepant), fast-dissolving tablet (Rimegepant), nasal spray (Vazegepant)

 

IGF-1

An intriguing treatment in early development is the use of insulin-like growth factor (IGF-1) in a nasal spray formulation. Humans typically produce IGF-1 in the liver; the hormone plays a role in puberty and human growth. Doctors have administered it safely for decades to treat growth disorders and other conditions. Now researchers with Seurat Therapeutics are exploring its potential to both abort and prevent attacks.

The idea behind Seurat’s project is “environmental enrichment,” a biological process triggered by rich, stimulating environments. Environmental enrichment can prompt the body to make more IGF-1, which can reduce neuroinflammation and oxidative stress. If Seurat’s nasal spray can replicate this process, it may reduce the neuronal hyperexcitability that is believed to be a major underlying factor in migraine disease. Addressing one of the root causes of migraine successfully would be a game-changer for millions of patients. Seurat’s project is in the preclinical stage, which means it may be several years before any treatment reaches the market. 

 

Key Points:

  • Manufacturer: Seurat Therapeutic
  • Availability date unknown.
  • Will be available as a nasal spray.

See a podcast episode about Seurat’s IGF-1 treatment here.

 

Neuromodulators

Devices called neuromodulators may modulate, or change, the neurological process of a migraine attack with electrical impulses delivered to the skin on various parts of the body. Several are currently available in the US, but the primary obstacle for many patients has been cost. They tend to be expensive and many insurance plans don’t cover them. Although they don’t always provide complete relief, many patients find them to be a valuable tool in their migraine tool kit. 

Among the latest developments in the neuromodulator arena is the Nerivio Migra, Theranica’s smartphone-driven treatment, which earned FDA permission in May 2019. The device is in a band patients can wear on the upper arm. The patient uses the smartphone app to control the intensity of the electrical impulses. Theranica.com states the Nerivio device is available with prescription at “participating clinics and specialty pharmacies,” but they expect wider availability in early 2020. An armband with 12 doses costs $99. 

Another novel method is in development at Nocira using earbuds and a smart-phone app to blow gentle puffs of air into the patient’s ear canals. Researchers believe that this method stimulates pressure-activated sensors in the external and middle ear, which then go on to send impulses to the vagal and trigeminal nerves to “reboot” and stop the pain. 

Although the device is still in the early stages of development, a pilot study showed two-thirds of patients were pain-free 20 minutes after trying the prototype. Nocira received a patent for the device in September 2019 and is planning clinical trials. 

Key Points:

  • Manufacturers: Theranica and Nocira
  • Medication Class: Neuromodulation
  • Efficacy: Varies depending on manufacturer
  • Theranica availability is expected in 2020, Nocira availability timeline is unknown

 

This is an exciting time for the migraine community. The Association of Migraine Disorders looks forward to tracking and reporting on the developments for these treatments in the pipeline. Stay tuned for the Association of Migraine Disorders’ annual Migraine Symposium which will feature a number of presenters speaking about these new options.

 


Sources:

https://finance.yahoo.com/news/lillys-reyvow-lasmiditan-first-only-194800978.html

https://www.neurologylive.com/clinical-focus/lasmiditan-approved-for-migraine-treatment-in-adults

https://www.prnewswire.com/news-releases/allergan-announces-fda-acceptance-of-new-drug-application-for-ubrogepant-for-the-acute-treatment-of-migraine-300809651.html

https://www.biospace.com/article/biohaven-s-migraine-drug-shows-superiority-for-freedom-from-pain-in-phase-iii/

https://www.americaninno.com/chicago/funding-chicago/seurat-therapeutics-gets-500k-for-its-migraine-fighting-nasal-spray/

https://www.seurat-therapeutics.com/

https://www.pharmasalmanac.com/articles/mimicking-environmental-enrichment-for-migraine-therapy

https://theranica.com/product/

https://www.neurologylive.com/conferences/ahs-scottsdale-2018/nerivio-migra-device-shows-success-acute-migraine-treatment

https://www.wearable-technologies.com/2019/05/theranicas-nerivio-migra-wearable-gets-fda-de-novo-for-migraine-treatment/

https://nocira.com/


Looking for more articles and information like this?

» Sign up for the AMD newsletter to have the latest information sent straight to your inbox each month. «

 

MEET THE AUTHOR


Lisa had migraine attacks for most of her adult life before being diagnosed with migraine disease. A communications strategist, writer, and former radio announcer, she lives in the Boston area, where she advocates for her fellow migraine patients every chance she gets.

Comments are closed.