CGRP

10 September 2020

CGRP Inhibitor – but, I hate injections!

James Discoveries & Stats, Medications 0

CGRP Inhibitors, as preventives, have a lot of advantages. Sure, they may be injections, but they’re not taken every day like most preventatives for migraine.

I mean, in the case of Ajovy, you’re looking at an injection every three months.

But I know, some of you are saying – seriously, I don’t care how often it is. I don’t do injections!

You might want to keep an eye on a new preventative that may come out in 2021 – atogepant.

Now if you remember our discussion of different types of “CGRP drugs”, you’ll recall that the “gepant” drugs are generally being marketed for acute treatment – to take once a migraine attack has already started. But this one, taken orally, is being tested for prevention.

Part of the phase 2 trial was published online in August. 825 patients received atogepant, but they were divided up to receive varying doses – 10, 30 or 60mg once or twice a day. 5% or less experienced nausea or fatigue with certain doses – that number may be lessened significantly once we figure out which dose is best. But overall, there were no serious side effects, and over 12 weeks the patients saw a significant decrease in their days with migraine symptoms.

Phase 3 results are already being reported as well, and results look similar. Patients got back several days each month – several more migraine-free days. A slightly better result seems to come with the higher dosages.

Although this will be a once or twice a day dose, it’s oral – no injections! So keep your eye on this one.

For more on the study, see Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. For more history, check out Allergan: atogepant. (Note that Allergan is now owned by AbbVie, so don’t get confused.)

7 September 2020

CGRP Medication Side Effects – “I hadn’t thought of that…”

James Discoveries & Stats, Medications 0

One of the things patients like about CGRP related migraine medications is that the side effects are often less than with other drugs. But there can be side effects.

Calendar clock — Side effects – mostly temporary…?

A recent study used a checklist to see if patients would notice other side effects that weren’t so obvious, or that they might not think of right away. The researchers were concerned that some of these were missed in some of the original trials.

This particular study was presented at the 62nd Annual Scientific Meeting of the American Headache Society, and came from the Chicago Medical School and Robbins Headache Clinic. 119 chronic migraine patients were first asked about side effects generally, and then they were handed a checklist.

The study itself is arguing for the use of checklists to identify side effects, but for us it is interesting to see which adverse effects were noticed using the checklist.

These patients had been on therapy for two months. What about you? If you’ve taken a CGRP related drug, have you noticed any of these? Here are the most commonly reported ones:

Constipation
Anxiety
Injection site reaction/irritation
Insomnia
Hair Loss
Muscle Pain/Cramps
Joint Pain
Irritability
Increased Headache
Depression
Nausea

Again, remember that generally speaking side effects from these medications have been mild. Some also go away with time. For example, many patients experience increased headache for a few days or a couple of weeks, but then start to feel better. Weight gain lasted from 1-4 months. Of course injection site reactions were usually very brief.

However, some symptoms could be ongoing, so do check with your doctor. Hair loss, constipation, and sexual dysfunction, for example, seem to last longer (but again, many people have no problems whatsoever).

What’s been your experience?

(Study abstract here (scroll down): CGRP Monoclonal Adverse Effects: Evaluation Via Use of a Checklist

21 May 2020

Vazegepant: Migraine and COVID-19

James Medications, News 0

A new drug is being testing that may be used both for migraine – and COVID-19.

The drug is called vazegepant (BHV-3500). It’s one of the “gepant” medications that we’ve talked about before. Generally, they should make great abortive drugs because they work quickly, but they are slower coming to the market because of the testing that is needed.

Vazegepant comes from Biohaven, the makers of rimegepant – sold as Nurtec ODT. Rimegepant is an abortive, but it’s being tested as a preventative as well.

Vazegepant is soon to enter phase 3 of testing as a preventative for migraine, given as a nasal spray. Biohaven says this about the new medication:

Vazegepant (BHV-3500), the second product candidate in our CGRP platform, is a highly soluble small molecule CGRP receptor antagonist. It is also structurally distinct from rimegepant. The chemical properties of vazegepant make the product candidate potentially suitable for multiple routes of delivery, including nasal, subcutaneous, inhalation or oral administration.
Vazegepant

So, another “CGRP” related drug, but with some unique properties. And one of those unique properties may be the treatment of COVID-19. Specifically, the treatment of more severe cases.

On the 8th of April, the FDA gave approval for the trial to begin. The hope is that vazegepant may help stop a major complication of COVID-19. Dr. Donnie McGrath from Biohaven explains: “There is a solid scientific rationale supporting testing of small-molecule CGRP antagonists as a way to mitigate the neuro-immune consequences of respiratory viral infections like COVID-19.” [source]

The phase 2 trial is now recruiting in the USA. If you would like information, the trial information is available here, with contact information: Safety and Efficacy Trial of Vazegepant Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen

27 April 2020

CGRP Drugs and Weight Gain

James Information, Medications, Tips 3

Do CGRP injections cause weight gain? If so, what can I do about it?

This is a (somewhat belated) response to a question from Char in the United States. If you have a question, use the button on the right to fill in the form.

Char was specifically asking if there is a CGRP injection that doesn’t cause weight gain.

One of the concerns that doctors have had regarding the new CGRP medications is that they are – well, new! Of course, every medication has to be new at some point. But what that means is that long term testing is really only starting. (For some of the concerns expressed early on, check out At Stake: The Possible Long-Term Side Effects of CGRP Antagonists. Weight change is one of the questions that is highlighted.)

So at this moment in history, we are waiting for long term trials, and also watching carefully clinical experience – that means your experienced with the drugs.

Many people are being helped by the new medications, but there are reports of weight change – not just weight gain, but weight loss. The Robbins Headache Clinic reported on some of the early experiences they had with the CGRP medications. Here’s what they’ve written about weight changes:

Bloating & Weight Changes: weight gain can be a problem, and if significant enough we stop the medication. This does not appear to be as much a problem as with other medications such as Lyrica, Depakote, gabapentin and the tricyclic anti-depressants, but we are seeing it. This could be because our feeding and hunger is centered in the hypothalamus which is not protected by the blood-brain barrier. A few people have lost weight, and if it is significant then we stop the medication.
CGRP QUESTIONS/ANSWERS

So in short, they saw both weight gain and weight loss. However – and this is important – CGRP related medications don’t seem to be the worst offenders when it comes to weight gain.

The Pain News Network also reported on a survey of those using the new medications. According to the survey, 12% of patients reported some weight gain (see New Migraine Prevention Drugs Making Inroads).

We have to remember that these are not controlled studies. And so we come to a very important question – are these drugs directly causing weight gain?

Here’s a simple example. If you are constantly nauseous, and a CGRP injection significantly improves your health, what just might happen? You might eat more.

This is the argument that Drugs.com makes for Aimovig. “Does Aimovig cause weight gain or loss?” – no, but changing migraine symptoms may. You may think that their answer is a little overconfident, but the fact remains that there may very well be a complex set of reasons why you gain or lose weight on a CGRP drug.

So back to Char’s concern – what to do?

First, be sure you are communicating your concerns with your doctor. This is a case when customized medical help is very important. Your doctor can help you find the best solutions for you.

Second, and this will help your doctor, be sure to keep a detailed diary of your symptoms and any changes that you notice.

Third, try another CGRP medication. Unfortunately, we simply do not know enough at this point to give you a list of CGRP related medications that are least likely to cause weight gain for you. Like many classes of drugs, it can make a significant difference if you try another drug of the same class.

And, of course, as your symptoms (hopefully!) lessen, take the time to learn and re-learn some basic healthy habits.

We would love to hear your experiences and suggestions – leave a comment! 🙂

12 March 2020

Vyepti to fight Migraine – How is it different (and what’s with the name?!)?

James Medications 0

In February, Vyepti was approved in the USA as a new migraine preventative. An application has been submitted for approval in Canada, and the European Union will be next later this year.

Vyepti (eptinezumab-jjmr) is yet another “anti-CGRP” medication, so it’s important to understand what is unique about it. Of course, as with any class of medications, one may work well for you even when another similar drug does not. And Vyepti does have a specific biological mechanism that is different than the other anti-CGRP drugs.

However, there’s more to it when it comes to Vyepti.

The key difference with Vyepti is the way you take it, and how often. As you may know, other medications in this class that have been approved are given by injection on a monthly basis (Aimovig, Emgality, and Ajovy). Now Ajovy is an exception, in a way, because it can also be taken quarterly (although it may be slightly more effective if taken monthly).

Vyepti, however, is specifically to be taken quarterly (every three months). It’s attractive for many patients that they only need to take a preventative only four times a year – especially those of us who have endured the two-or-three-times-a-day routine for some medications.

Vyepti is unique in that it is given as intravenous (IV). The usual recommended dose is 100mg (although some patients may need 300mg). This amount is diluted, and given via IV over 30 minutes.

This may sound more extreme than an injection, but many patients might prefer an IV given by a doctor to having to do their own injections.

A positive for this drug is that there seem to be few side effects. The most common ones (which weren’t all that common) occurred actually during the IV. A “stuffy nose” was probably the most common issue.

You may wonder, if this drug is taken so occasionally, how long it takes to start working. The good news is that it seems to start working on “day 1”. Clinical trials have shown that Vyepti reduces the number of migraine days per month, even for those with chronic migraine.

To read more, you can visit the official Vyepti site here. Also check out this helpful article: Breaking News: Eptinezumab-jjmr (VYEPTI™) Approved by FDA.

But in closing we have to ask, what’s with the name?? On the Vyepti website, the authors insist on capitalizing the word (VYEPTI – does that stand for something?), although on other sites the writers resist shouting at their readers. And the official logo is all lowercase.

To some, Vyepti may sound like a mysterious furry creature that roams the mountains.

How drugs get their names is a fascinating study. And I would love to hear more about how VYEPTI got its name. Do you know?