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An Update on AXS-07 (upcoming migraine medication)

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A new study has come out on AXS-07, a new abortive combination medication. With all the talk about injections, many patients will be glad to see a new “pill” coming down the pipeline!

You can find out more about AXS-07 here. In short, it’s a new formulation of meloxicam/rizatriptan. The latest news comes from the completion of a phase 3 trial.

The quick summary that’s promoting AXS-07 is that it has been shown to “prevent pain progression”. So what does that mean?

For many in the trial, AXS-07 did lead to “pain freedom” between 2 and 24 hours, a common measurement when it comes to pain medication. But these numbers, although significant, weren’t unusually high, although some patients did find they were pain-free as quickly as in 30 minutes.

So the even better news is that almost 3/4 of patients in the trial found that their migraine attack didn’t go beyond “mild” when they used AXS-07. The same percentage went back to “normal functioning” within 24 hours.

The other good news – no serious side effects, and very few experienced the most common side effects (such as dizziness, fatigue, or paresthesia (eg “pins and needles” feeling on the skin).

For more information, see:

AXS-07 – New Combination Drug for Migraine in the Pipeline

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Axsome Therapeutics has a new combination abortive drug in the pipeline. At the moment it’s going by the name AXS-07.

AXS-07

Every new medication attempts to solve one or more problems. This one is focused on two – well, maybe three – different things. First, fast absorption. The medication needs to get into your system at full power as soon as possible.

Second, it needs to keep working long enough to really make a difference. And when we say “working”, that brings us to a third thing – alleviation of symptoms.

This medication is a combination of two medications. First, rizatriptan, an already well-known abortive drug that targets migraine specifically. The second is meloxicam, which is a type of NSAID, specifically a COX-2 NSAID. That would put meloxicam in the same class as Celebrex (celecoxib), which may be a little more familiar to you.

Axsome is using a special formulation of meloxicam (“MoSEIC™ meloxicam “) that is designed to get into your system faster and last longer. Since both of these medications attack migraine in different ways, they have the potential to attack different symptoms in a more complete way.

That’s what the developers hope. There are two trials that are starting, if you’re interested in being a party of the development of AXS-07. Both are in the USA, and all the contact information is here:

For more information, see Axsome’s site: AXS-07

Stop Paying for Migraine Drugs – and Take Placebos?

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A study published this month is sparking debate about whether or not we should even bother paying for common migraine medications.  Does a “fake pill” work just as well as the real thing?

Headlines such as “Migraine sufferers benefit from placebos, study shows” may be sending the wrong message.  So – migraine is all in their heads after all?  People can just “think” their headaches away?

But if you know anything at all about the science of medicine, your reaction is more likely to be – this is news?  Really?!

Placebos usually refer to treatments that are thought to be “real” but aren’t.  In this case, there’s the common migraine medication rizatriptan and a pill that contains no medicine at all.

It’s no surprise at all that placebos help with a variety of very real conditions – including many pain issues, and even conditions such as congestive heart failure.  Well designed studies control for the placebo effect.  It’s nothing new at all.

There are positive and negative effects.  The nocebo effect happens when a treatment seems to harm someone when they think that it will.

In this particular study, it was found that rizatriptan did work better than a placebo.  However, if a patient thought that a placebo was rizatriptan, they did just as well as the patient who thought the rizatriptan was a placebo.  Positive and negative impact worked together to level the playing field.

This study certainly shows us again how powerful the placebo effect can be.  It does not, however, negate hundreds of studies showing that migraine treatments are usually more beneficial than a placebo.

It should also be noted that the study covered just 6 migraine attacks per person, and so does not say a lot about long term treatment.

What we do want to do is harness the power of the placebo effect.  In spite of the fact that most people want their doctors to tell the truth, the truth is that many, many doctors actually do prescribe placebos as if they are “real” medical treatments, knowing that the ruse will often help the patient.

On the more ethical side, most doctors do speak positively about a drug that should help you.  “Expecting the best” will increase your odds, no doubt.

So although there is no scientific reason to doubt the power of real migraine medications that have been carefully researched, there is also good reason to continue investigating placebos for all kinds of medical conditions.  We may not be able to think our way to a migraine cure, but being positive can make a huge difference.

Study abstract:  Altered Placebo and Drug Labeling Changes the Outcome of Episodic Migraine Attacks

Triptans for Children and Adolescents

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Triptans, drugs developed specifically as migraine abortives, have long been used by adults.  And children too, actually.  But the adults have benefited from much better information – trials, studies … but things are improving for children.

Studies on triptans for children have suffered because of various factors.  Obviously, experimenting on children is rightly frowned upon.  Also, there’s a very high placebo effect when it comes to children.  Finally, the data is going to be, by nature, short-term.

Two drugs are approved in the USA for use with children/adolescents of various ages – rizatriptan (Maxalt) and almotriptan (Axert).

Reading through some of the study reviews, it seems that besides these, sumatriptan (Imitrex) and zolmitriptan (Zomig) have the greatest potential for treating children.

Two more important notes.  Triptans have generally been safe for children, when taken carefully under the supervision of a doctor.  A child should never be given someone else’s prescription.

Second, some triptans work in one form and not in another.  It’s very common to prescribe a nasal spray for a child, for example.  Wafer medications may also be effective.  Read more here.

Sometimes children don’t like the “aftertaste” of a nasal spray.  Try giving them a hard candy after taking the medication.

There is one more thing that is unique when it comes to child migraine.  The attack tends to pass quicker than it does in adults.  If you find that the symptoms go away just as fast without the triptan, skip the medication and try a simple home remedy.  This will avoid issues that can come with medications, and still give the child a feeling of “control” over their symptoms.

More information:

Triptans (and more) for Children with Migraine

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I think parents will appreciate a recent post from Dr. Alexander Mauskop regarding treatments for children.  Here is a summary of his suggestions:

  • Try wafer medications (that melt under the tongue) or nasal sprays.  Rizatriptan is approved in the USA for children, and Maxalt MLT is a “wafer” medication.  Imirex NS (sumatriptan) is a nasal spray approved in Europe, and Zomig NS is another available in the USA.
  • Some common triptans used for children include rizatriptan (in the USA approved for children as young as 6), almotriptan, sumatriptan, and zolmitriptan.
  • Rizatriptan will be available in generic form around the end of 2012.
  • Child migraine attacks tend to pass quicker than adult attacks.  This is another reason why faster acting medications are helpful (such as nasal sprays), but may also explain why some children tend to get over the attack quickly (in an hour or two) no matter what they take.
  • Triptans should not necessarily be the first choice for children with migraine.  Other options include ibuprofen and paracetamol/acetaminophen, lifestyle changes (regular sleep/meals/exercise), biofeedback, magnesium, CoQ10, etc.

For more tips for treatment of children with migraine, read Triptans for pediatric patients

Another reminder or two – just because a triptan hasn’t been “approved” for children in your country does not mean that it won’t be effective.  It just mean that the required studies haven’t been completed.  However, always talk to your doctor before giving your child a triptan medication (or any medication, for that matter) for migraine!

Also, don’t be surprised if your doctor isn’t quick to recommend a pill.  There are excellent, well proven non-drug treatments for children (some are mentioned above).

Read more about Pediatric Migraine Medication here.

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The articles on Headache and Migraine News are © 2004-2024 J. Cottrill.
Every effort is made to ensure the accuracy of each article, and to point you to further sources of information. However, this site is for informational purposes only and should never replace a visit to your doctor.