Oral CGRPs Phase 3 Clinical Trial Now Recruiting
Biohaven Pharmaceuticals announced on March 6, 2018 that patients may enroll in a Phase 3 clinical trial to evaluate the oral dissolving tablet (ODT) formulation of rimegepant.1 Rimegepant belongs to the class of therapies that target calcitonin gene-related peptide (CGRP) receptors and is being evaluated for the acute treatment of migraine.
The Phase 3 trial will compare rimegepant to a placebo and is expected to enroll approximately 850 patients who experience migraine. Vlad Coric, MD, and CEO at Biohaven Pharmaceuticals said, "The fast-dissolving Zydis® ODT rimegepant formulation is designed to conveniently enable people experiencing a migraine attack to promptly initiate their acute treatment without the need for taking with liquids."1
What's the big deal about rimegepant?
If rimegepant is FDA approved, this could offer those suffering with migraines a new treatment option. Earlier studies of rimegepant have shown improvement in migraine symptoms, and since water is not needed, it adds convenience and importantly could lead to taking a needed dose sooner and that could result in more effective treatment. Also, rimegepant may have a lower rate of migraine recurrence than other therapies.2 In clinical trials to date, rimegepant has not been associated with any serious adverse events and has generally been well tolerated.2,3 If approved by the FDA for the acute treatment of migraine, it could benefit more patients than the commonly prescribed triptans, since rimegepant can be also taken by patients who have heart disease and high blood pressure.2
What is CGRP and how do CGRP therapies work?
CGRP is a very small protein that acts as a neurotransmitter - that means it binds a receptor and relays information.
CGRP therapies, like rimegepant, work by preventing CGRP from binding its receptor. Some CGRP therapies are small molecules, like rimegepant, but other therapies are antibody therapies.
Why is CGRP being targeted in migraine therapies?
While the role of CGRP is migraine is not well understood, there are several lines of evidence that make targeting CGRP a smart idea when developing pharmaceuticals to treat and prevent migraine.4
- Migraine patients have high levels of CGRP in their blood. When they are treated with triptans and experience pain relief, their CGRP levels drop.
- Injecting a patient with CGRP can induce a migraine or migraine-like headache.
- Disrupting CGRP from binding to its receptors with antibodies or small molecules shows promising results in clinical trials addressing the treatment and prevention of migraine (acute, chronic, and episodic).4
Where are other CGRPs in the clinical development pipeline?
In addition to rimegepant, there are several other drugs in development that target the CGRP receptor. The CGRPs in the development pipeline for migraine are as follows:
- Allergan - Ubrogepant is a small molecule therapy that can be taken orally as an acute treatment of migraine. In February of 2018, Allegan announced positive results in Phase 3 trial and anticipates filing a New Drug Application (NDA) with the FDA in 2019.5
- Teva - Fremanezumab is an antibody therapy for the prevention of migraine. In December, 2017, Teva announces that the FDA accepted their Biologics License Application (BLA) for review.6
- Eli Lily - Galcanezumab is an antibody therapy for the prevention of migraine. Lily expects a third quarter, 2018 approval from the FDA.7
- Novartis and Amgen collaboration - Erenumab is also a preventative antibody therapy -that was recently characterized in an New England Journal of Medicine article.8 This was approved by the FDA on May 17, 2018.
- Alder Biopharmaceuticals - Eptinezumab is an antibody therapy for migraine prevention. In January, 2018, Alder Biopharmaceuticals announces Phase 3 data is positive and that they are on track to submit a BLA in late 2018.9
Where can I learn more about clinical trials for rimegepant and other CGRP drugs?
For more information about rimegepant and clinical trials, click here.
If you're interested in other drugs, simply replace "rimegepant" with your drug of interest in the search engine.
What will the orally dissolving rimegepant cost?
The jury is still out on what the new CGRP treatments will cost patients. The Institute for Clinical and Economic Review (ICER) hasn't published a report for acute migraine treatment with CGRP treatments yet, but you can read about the draft report published in April, 2018 on CGRPs in chronic and episodic migraines here. Once ICER has published finalized reports on the cost-effectiveness of CGRPs for acute, chronic, and episodic migraine, insurance companies will use these reports to evaluate which drugs they want to cover, and how much of the cost they want to pass on to the patient. A final consideration for the ODT formulation of rimegepant that may drive up the price is that Biohaven Pharmaceuticals has partnered with Catalent, Inc. to gain access to their Zydis® technology that makes the treatment dissolve in your mouth.
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