A Glance At Recently Approved and New Medicines Hitting the Market Going Into 2022

A green backdrop with a Polaroid white frame enveloped in leaves. The text in the frame reads “Nurtec… Qulipta… Zavegepant and Trudhesa”

Continued research into CGRP in the role of migraine along with prioritizing a variety of methods for absorption have opened up a variety of new medications for both preventative and acute treatment of migraine.

If you missed the previous post covering Reyvow, Ubrelvy, and Vyepti you can reference it here.

The primary development has been with the Gepant class of medications and the shift towards using the acute medications for prevention as the risks for Medication Overuse or rebound do not seem to be a factor. This has allowed the way we approach treating migraine to shift dramatically as we have safer options that appear to be much more tolerable.

This research also further expands treatments designed intentionally for the use of migraine, rather than the vast majority of headache and migraine medicine up until this point being designed primarily for other conditions and indications.

The secondary focus of the latest research has been on absorption.

The Migraine World Summit highlighted absorption of medications as one of the primary disadvantages patients face when it comes to medicine being effective. The numbers are somewhere around 80% of people with migraine have a co-occuring condition impacting their gut. These conditions including Irritable Bowel Syndrome, Gastroparesis, and Cyclical Vomiting Syndrome all interfere with our natural ability to absorb nutrients that pass through our digestive system.

Until now, the main form of medication has been oral tablets. For people who have migraine, this means we likely are not absorbing the medications as they have been designed. Research has shifted to develop medications that can be absorbed more rapidly including dissolvable tablets and nasal sprays.

Below are the new medicines that have recently hit the market along with the latest gepant which will be submitted for approval early in 2022 that is worth keeping an eye on.

Nurtec ODT for the Acute and Preventative Treatment of Migraine

Nurtec ODT (Rimegepant) is the first of the gepant class – and of any migraine medicine – to have been approved for both the acute and preventative treatment of migraine. Nurtec was first released as the second gepant on the market after Ubrelvy in the form of an orally dissolvable tablet. It works by acting as an antagonist to the CGRP receptor.

Nurtec was first approved early in 2020 to use as an abortive, but received approval to be used on an every other day basis in early 2021 for use as a preventative medication.

As a dissolvable pill, Nurtec may allow for better absorption compared to Ubrelvy, which is beneficial to people who have comorbid GI conditions or experience GI disruptions during their migraine attacks. Nurtec was also the first pill form of the CGRP drugs approved for preventative use allowing people to use a medication with a shorter half-life compared to the injectables. Nurtec’s half life is 11 hours.

Risks and Side Effects:

  • Nausea
  • Indigestion/Stomach Pain

When used as an abortive, you can only take 1 dose of Nurtec in a 24 hour period of time.

Important notes from Clinical Trials:

These relate to the studies for Nurtec as a preventative:

  • In trials, “49% of patients taking Rimegepant had a 50% or more reduction in moderate to severe migraine days compared to 41% in placebo.”
  • “Within the 1st week, there was a 30% drop in migraines (compared to 9.4% drop in the placebo group).”

Cost:

Nurtec has a hefty price tag of $874 for a single package of 8 doses, which is the monthly allotment for acute treatment. However, BioHaven has released a $0 copay card which you can access more information about here on their website.

For patients who do not qualify for drug discount programs, the drug price will vary substantially. For some health insurances they are considering Nurtec to be the preferred gepant meaning it 1) may be covered, 2) may be available at a lower cost, or 3) may be required as a step therapy medication prior to accessing other gepants.

Personal Notes on medication/review

I tried Nurtec as an acute treatment this previous spring and as a preventative this previous summer. You can read my personal acute experience here and a collection of patient preventative experiences here.

I personally have had good success with the other gepant – Ubrelvy – and as noted across the patient community people seem to have good success with one or the other, rarely both. With this in mind, like the injectables and triptans before them trying out multiple medicines within the drug class may get you closer to relief.

Currently there are some prescribing barriers to Nurtec when it comes to a combination treatment as a preventative and an abortive and insurance companies are reportedly only allowing patients to use it as one or the other, rather than both.

Qulipta for the Preventative Treatment of Migraine

Qulipta (Atogepant) is the most recently approved gepant, hitting the market during the Fall of 2021. Qulipta is the first daily oral tablet in the gepant class designed for the prevention of episodic migraine. It is available in three dosages 10mg, 30mg, and 60mg all with promising therapeutic benefits beginning almost immediately after starting the drug. Chemically, Qulipta is very similar to Ubrelvy but allows patients to take the medication daily rather than limiting it to 10 times in a month.

Risks and Side Effects:

  • Constipation
  • Nausea
  • Fatigue
  • Reports of decreased appetite

It has been notated that the risk of side effects and their severity is equitable between the 30mg and 60mg doses.

Important notes from Clinical Trials:

  • In the first week there was a 53% reduction in migraine days on Qulipta compared to a 30% reduction on Nurtec with the placebo having a 15% and 9% respective reduction.
  • They evaluated the percent of patients who experienced a 50% reduction (or more) in migraine days throughout the 12 weeks with Qulipta reaching 61% after 4 weeks, 66% after 8 weeks, and 71% after 12 weeks. This shows that a substantial amount of patients saw a lot of relief early and had continued reduction as they continued taking the medication.
  • Another figure shows Qulipta patients saw 8% of patients having 100% reduction in migraine days per month, but has some confusing figured regarding when during the 12 weeks they experienced it.
  • “By the end of the trial, and after a continued decline in migraines, patients were averaging 71% less migraine days per month, which equated to 5.2 less migraine days per month on average.”

Cost:

A 30 day supply of Qulipta costs $991 at wholesale cost.

Abbvie has set up a cost savings program for Qulipta in addition to an extensive mentoring program helping guide patients through insurance and general questions. When you enroll in their cost savings program, which can be found here, they automatically will connect you with the mentoring program. If you qualify, you can receive Qulipta for $0 a month.

For those who do not qualify, your insurance may require a prior authorization for the medication and your cost will vary. From my experience with Express Scripts, my cost can vary between $29 and $60.

For an in depth comparison between Nurtec and Qulipta, consider reading this piece by The Virtual Headache Specialist. I have referenced some of this article when sharing results of the clinical studies as it is broken down in a very understandable way.

Zavegepant for the Acute Treatment of Migraine

Zavegepant is the latest gepant in development with reports that BioHaven will be filing for a new drug application in the beginning of 2022 after publishing positive results with it’s latest trial. Zavegepant is the first intranasal spray in the gepant class. It is also in studies in the form of an oral tablet. It is reported to be the first medication to provide rapid relief within 15 minutes of administration.

Risks and Side Effects:

  • not yet disclosed

Important notes from Clinical Trials:

  • patients began returning to normal function as soon as 30 minutes after administration
  • patients reported freedom from most bothersome symptom within 2 hours

Since these trials are not formally published yet, information will be updated once trials are publicly available.

Cost:

Cost is not yet available. Current nasal spray’s and other CGRP medications are all on the most expensive end of the spectrum as a reference point.

Disclaimer: Since this medication has not received FDA approval as of yet, all information is based on reports directly from Biohaven. This article will be amended to either notate approval was not acquired or with more accurate information on side effects, trial notes, cost and expected availability.

Trudhesa for the Acute Treatment of Migraine

Trudhesa is the latest innovation in using DHE (dihydroergotamine mesylate) to treat migraine. Previously, DHE has been used as a multi-day infusion to break stubborn migraine attacks or interrupt Medication Overuse Headache. Migranal was the first nasal spray form of DHE available on the market. Trudhesa enters the market with innovative new methods building upon research regarding the best absorption methods for medications. Trudhesa uses what’s called a Precision Olfactory Delivery method providing an extremely targeted dose into the upper nasal cavity.

This method of absorption and the research into the upper nasal cavity were heavily discussed in this year’s Migraine World Summit as one of the more promising areas of research.

Trudhesa was approved in September 2021 for the acute treatment of migraine.

Trudhesa is not used to treat other types of headaches such as hemiplegic or basilar migraines. Although DHE is used for Medication Overuse Headache (MOH), this acute therapy has not been indicated for use with MOH.

Risks and Side Effects:

Side Effects:

  • runny nose
  • nausea
  • abnormal taste
  • application side reactions
  • dizziness
  • vomiting
  • sleepiness
  • sore throat
  • diarrhea

This drug is not to be taken with strong CYP3A4 inhibitors.

This drug cannot be taken within 24 hours of triptan or ergotamine/ergotamine type medications.

Do not take this drug if you have heart problems.

**For a full guide on interactions and risk factors, please refer to the medication guide.**

Important notes from Clinical Trials:

  • Patients report relief as early as 15 minutes after use.
  • Pain freedom may last upwards of two days after a single dose.

Cost:

A pack of four doses costs $850 and is only available from specialty pharmacies.

The manufacturer has a cost savings program allowing you to receive Trudhesa for as low as $10 per prescription, which you can learn more about here. This is again only for qualifying patients.

Express Scripts requires a coverage review for this medication and it is placed in the highest copay tier if approved.

Please note that if you have a sensitivity to harsh contrast the Trudhesa website may be hard to look at, it’s landing page is bitch black with high contrast white text.

What Does This Mean For Me?

As always, I do like to take a moment to share some of my own personal thoughts and concerns regarding the new medications. The biggest excitement for me is the continued development with gepants after I found success with Ubrelvy.

I have my reserves and theories when it comes to the broader CGRP medications and how they interact with comorbid conditions, particularly autoimmune disorders like arthritis. Many of you have read my experience with both Aimovig and Nurtec where I had similar worsening of migraine pain but also side effects that worsened my arthritis. I have not had this experience with Ubrelvy, so I think it’s a worthwhile area to pay attention to and remain aware that the chemical formulas for these drugs vary a good bit so patterns may emerge with people who find success with some and severe side effects with others.

At the moment it looks as is Ubrelvy matches up well with Qulipta, which I am currently trialing, whereas Nurtec may match up with Zavegepant.

Qulipta is the medication I am most hopeful for due to the wide possibilities this drug may open up for me, so I will report on my experience with it as time goes on.

  • The extreme reduction in migraine days in clinical trials is not something I have ever seen before.
  • Despite the research primarily being on episodic patients, I think the translation of these results to chronic patients would be huge strides forward.
  • My personal goals for this medication are to hopefully experience those evasive “migraine free” days and to reduce the frequency with which I need to take an abortive medication. I currently take and abortive roughly every 3-4 days, so pushing that out to consistently every 5 days would be a good marker of progress for me.
  • I also hope to be able to trial this drug as a long term addition to my care plan. I haven’t had a new tolerable option for years when it comes to preventative medications.

Trudhesa however is a drug that doesn’t interest me one bit. I have had access to Migranal for a few years and I honestly don’t enjoy using it. I have it in my emergency kit, but it is quite an unpleasant drug. Trudhesa is the same drug with a slightly more precise mechanism for delivery so I imagine the side effects would be identical.

  • This drug will be a great alternative to Migranal and for people who can tolerate the side effects I would encourage switching over. I also think it would be smart for this to be the first choice over Migranal simply due to the new developments in research prioritizing innovations in upper nasal cavity absorption.
  • This medication has a huge amount of interactions and risk factors, so although it is an available therapy, with the addition of so many other drugs that have more tolerable side effects at the same cost I just don’t see this being a worthwhile medicine.

There are a lot of new and continuing developments and I think the most notable part since my last published piece is the addition of public awareness for new therapies. The gepant drugs have come with high profile celebrity endorsements filling tv commercials and social media ads. This may be annoying for folks who are first in line to try each new medicine as it comes out, but it means a broader population is being exposed to migraine treatments.

This has implications like doctors that aren’t necessarily well read on headache medicine knowing new research is happening and having an increased awareness compared to when the initial injectable CGRPs hit the market.

It also means family and friends may have slightly more awareness that new treatments exist, albeit it still takes a lot of ground to cover what is actually considered a “successful” response to treatment. Overall, I view it very positively and look forward to this next round of medicines.

A.

Drug information in this article is summarized directly from drug websites: Nurtec, Qulipta, Trudhesa, while information regarding Zavegepant is compiled from press releases from BioHaven.

All information is intended to be educational but it is not intended to replace information from your doctor. I have done my best to convey information in a clear and concise way in a singular post allowing easier access for finding this information but I cannot promise I have not misinterpreted it. Some information may not be accurate and I would recommend reading over the clinical trials for the raw data and discussing any questions you may have with your doctor.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s