Medical Research Studies Making News: 9 Migraine Medication to Watch for in 2018
Bringing You the Medical Research Studies That Matter
There has been a lot of medical research studies making the news the last couple of months where migraine headaches are concerned. So much so that you are probably confused by what is going on in the field of migraine. In this article, I will look at 6 CGRP receptor antagonists and 3 other medication/combinations making research news.
CGRP Receptor Antagonist Medical Research Studies
Doctors have been promising that a new class of migraine medication is on the horizon for the past few years. So just what is this magic medicine that we have heard so much about and how does it mark a difference in the treatment of migraine headaches?
This new class of drug is known as calcitonin gene-related peptide (CGRP) receptor antagonists. Yes, that’s a mouthful! There are 6 different biopharmaceutical companies or partnerships who are studying these drugs and the results are promising. We will take a look at each of these, but first, let’s discuss the role of CGRP in migraine headache attacks.
If you’ve read anything about migraine headaches, then you might be familiar with the role of serotonin and dopamine in migraine. The body is triggered for whatever reason to increase the production of serotonin which increases the release of dopamine. This, in turn, triggers the trigeminal nerve to become inflamed. But what happens then? This is where CGRP comes in.
When the trigeminal nerve becomes inflamed, the brain produces increased amounts of CGRP, a normal protein found in the brain and in saliva. This increase causes the blood vessels on the surface of the brain to become inflamed and vasodilation occurs (the blood vessels swell and dilate), pressing on the nerve endings in the meninges (sac-like coverings) of the brain. CGRP receptor antagonists bind to these proteins and prevent them from connecting to their receptors, preventing vasodilation and/or stopping and the resulting cascade of symptoms of a migraine headache attack.
CGRP receptor antagonists are not as new as you might think. The first CGRP receptor antagonists were studied and tabled back in 2009 when after Phase 1 trails, by Bristol Myers Squibb and Merck noted a high number of patients developed liver toxicity. It is believed that this was caused by a metabolite (byproduct) of the original monoclonal formulations used. There has been much study since then, and current trials have not shown any patients developing this problem.
Now that you see how CGRP receptor antagonist basically work, let’s look at each company and the medications they are working on.
6 Companies/Partnerships in the Race to Market
1 – Adler Pharmaceuticals
Adler Pharmaceuticals is in secondary (their PROMISE 2) Stage 3 trials for eptinezumab, a first generation CGRP receptor antagonist. Previous Phase 3 trials have been promising with headaches being cut by an average of 8.2 days as compared to 5.6 days with the placebo.
Eptinezumab is given in the form of an infusion (medication given through an IV over a period) which was received by patients every 12 weeks as a preventative (prophylactic) measure for migraine. Relief was found to be effective, rapid and sustained with 52% of 1072 patients reporting a decrease of symptoms on the first day. On average, 50% reported a decrease of 50% or more, 33% reporting a decrease of 75%, and 15% reporting a 100% decrease in their headache days.
Alder expects results from their secondary Phase 3 trials in the first half of 2018 and is expected to file for a Biological License Application late in 2018. If approved, they could bring eptinezumab to the market by very late in 2018 or early in 2019.
2 – The Allergan Pharmaceuticals
Allergan pharmaceuticals is in early trials for two medications: ubrogepant for the acute (rescue) treatment for migraine headache attacks, and atogepant for the preventative treatment of migraine.
Both medications are in a more convenient pill form which Allergan believes will keep them competitive in the CGRP market even though ubrogepant is not expected to come to market until 2019, and atogepant is not expected to be released until 2022. There are no numbers out yet as to their efficacy.
3 – Amgen/Novartis Partnership
Amgen and Novartis, familiar names in the pharmaceutical world, have partnered to study erenumab, which is being hailed as the “first new (migraine) drug in 20 years.” According to the first Phase 3 trials, this CGRP receptor antagonist which is given by injection monthly, cuts headaches and headache days in half. Some patients were migraine free after three months.
The United States Food and Drug Administration is in the process of reviewing their application for approval now. Erenumab could come to market as early as the middle of 2018.
4 – Biohaven Pharmaceutical Holding Company, Ltd
Biohaven Pharmaceutical Holding Company Ltd, of New Haven, CT, a biological pharmaceutical company, has received approval of two Phase 3 trials for its BHV-3500. a third generation CGRP receptor antagonist. One of the trials are for a rescue (acute) form of the drug and the other is for the preventative treatment of migraine. Results from both trials are due in the first quarter of 2018.
Biohaven has also received an agreement from the FDA for an Initial Pediatric Study (iPSP) for rimegepant, as second-generation CGRP receptor antagonist. This is a requirement for a New Drug Application (NDA).
5 – Eli Lilly
Another familiar pharmaceutical company, Eli Lilly, has filed for approval of galcenezumab, a CGRP receptor antagonist given monthly by an auto injector. The filing includes positive data from their EVOLVE !< EVOLVE @ and REGAIN studies . (Phase 3 trials). These studies evaluated 2901 patients. They noted an improvement in 95% of the patients studied.
Adverse reactions ranged from reactions at the injection site to pain at the injection site. Galcenumab is the first of three non-opiods in Eli Lilly’s pain portfolio. This includes, lasmiditan, the only drug to target serotonin 1F receptors.
6 – Teva Pharmaceuticals
Teva Pharmaceuticals is racing with Amgen/Novartis to bring a CGRP receptor antagonist to the marketplace. In their Phase 3 studies of 1130 patients, Teva’s fremanezumab resulted in a decrease of 4.6 headaches and 13.2 headache days or roughly 50% overall. Teva filed for approval in October and aims to be in the market before late 2018.
CGRP Receptor Antagonist Wrap Up
More people around the world suffer from migraine headaches then diabetes, epilepsy, or Asthma. The last targeted treatment to come out were triptans, more than 20 years ago. Triptans, however, treat only the symptoms of migraine headaches, however, CGRP receptor antagonist actually prevents or stops a migraine headache attack by acting at the source of the headache.
The long-term effects of CGRP receptor antagonist remain unknown and the cost is estimated to be approximately $8500 per patient per year. Do not expect that these drugs will be easy to get either. Insurance companies may be slow to cover the new medication and it is expected that CGRP receptor antagonist will, at least at first, only be given after exhausting all other measures of established treatment.
These CGRP medical research studies are still important to nate. If you are resistant to the more traditional migraine treatments already being offered, you need to make sure that this has been well documented by your doctor, so that you can take advantage of the CGRP receptor antagonists when they hit the market later this year.
Other MedicalResearch Studies Making Migraine News
While the news on migraine research has been dominated by CGRP receptor antagonist, they are not the only medical research studies making the news. Let’s take a look now at three other medication options that have made the news.
1 – Axsome Therapeutics
Axsome Therapeutics, a biopharmaceutical company, recently announced its AXS-07, a combination of Molecular Solubility Enhanced Inclusion Complex (MoSEIC) meloxicam, and anti-inflammatory, and rizatriptan, a rescue medication already being used in the treatment of migraine headache attacks.
Early stages of MoSEIC meloxicam have shown rapid absorption of the meloxicam while maintaining a long plasma half-life (the amount of time before the amount of the drug reduces to half in the bloodstream).
AXS-07 is the second drug that uses MoSEIC meloxicam. Rizatriptan is already a proven single agent in migraine treatment with a strong efficacy. Axsome expects its Phase 3 trials to show superior, rapid, and consistent relief along with lower symptom recurrence than with current therapies because:
- rapid onset of pain relief is expected
- strong and efficient pain relief is expected
- sustained relief due to the 20-hour half-life of MoSEIC meloxicam
- efficacy in various stages, severities, and subtypes of migraine are expected.
Axsome expects these factors to result in a decrease in costs due to the lessened need for rescue medication, medical series, absenteeism, and the loss of productivity compared to current treatments.
What’s Old is New Again
According to findings of a study presented at the Anesthesiology Annual Meeting at the end of November 2017, ketamine, when used in the refractory treatment of migraines, improved pain scores. Sixty-one patients with refractory migraines were included in this small study.
Participants were infused with a sub-anesthetic dose of ketamine over a period of 3 to 7 days in a hospital setting with trained personal monitoring their progress.
Adverse side effects included sedation, blurred vision, nausea and vomiting, visual and/or auditory hallucinations, vivid dreams, and hypotension (low blood pressure). While more study is needed to evaluate the use of ketamine in refractory migraines, it does offer hope for migraine sufferers.
It Starts With One
In a single case study presented in Permanente Journal found the combination of famciclovir, an antiviral used to treat herpes simplex, and clecoxib, a non-steroidal anti-inflammatory (NSAID) eradicated the occurrence of migraine headache attacks in a young woman who had developed chronic migraine after a herpes simplex infection. This seems to support previous literature that migraine headaches are caused by the herpes simplex virus residing in the trigeminal nerve.
Obviously, more research is needed to establish the link to herpes simplex as well as this combination of medications, but if findings hold true, there may just be not only a treatment for migraine, but a cure.
Wrapping it All Up
While none of these treatments in the medical research studies are available today, some will be available in the coming year. They are all certainly things which could and probably should be discussed with your doctor or other migraine specialists. You may even be able to get in on the research being done in some of these areas.
In the case of the coming CGRP receptor antagonists, now is the time to make certain that all previous failed efforts to treat your migraine headache attacks are well documented so that you will be a better candidate once they hit the market later this year.
As always, I want to hear from YOU! What are your thoughts, questions, concerns or experiences with migraine and the future of treatments? What would you like to read more about? Is there a product you would like me to review?
Let’s continue the conversation! Leave me a comment below!