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FDA Approves 1st Skin Patch to Combat Migraines

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4 Star

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FDA Approves 1st Skin Patch to Combat Migraines

Our Review Summary

Strong points included the perspective of two independent experts. Weaker points:  incomplete discussion of costs, insufficient analysis of the evidence, and some questions bordering on disease-mongering.

 

Why This Matters

Migraine headaches are a common cause of pain and debility in people who suffer from them. Fortunately there are good medications to treat the range of frequency and severity seen in clinical practice. This new product probably will fill a small but potentially important niche. First, many migraine suffers have infrequent and not too severe symptoms. For these individuals, over-the-counter, inexpensive medicine like acetaminophen, ibuprofen, and others with or without caffeine work fine. For more frequent and severe episodes, there are migraine preventive medicines. The triptan class of medicines is generally used for individuals who have severe migraines that don’t respond to over-the-counter medicines whether used infrequently as stand alone medicines or with preventive medicines when breakthroughs occur. For most triptan users, oral medicines when used at the start of symptoms don’t cause serious stomach problems and work to relieve symptoms quickly. However, some patients have severe nausea that prevent taking the pills or result in vomiting before the medicine is absorbed and can work. For these individuals, injections, intranasal spray or pills with stomach-settling medicines are used. These are the patients in whom a skin patch approach should be compared. This placebo trial says the medicine works. The real question patients want to know is whether it works better than standard medicines and in whom. As we think about cost – one needs to consider whether an expensive new formulation provides enough new benefit to justify its likely hefty cost.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story says it’s “not clear” how much the new patch will cost, which is accurate, but Bloomberg was able to provide a ballpark estimate from a company official, who said it would be in the $95 range. Since this HealthDay piece references the same Bloomberg story when discussing the planned launch of the new product, we’re not sure why it didn’t pass along the $95 figure as well. We’re pleased that the story at least raised the issue of cost, but we’ll fault it for not providing detail that was easily available. You’d also like to see the cost per migraine episode of this medicine vs. alternatives.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story provides active and placebo group response rates for patients in the Zecuity studies, which we’ll call good enough for a satisfactory. However, the story doesn’t compare these results with injection and nasal spray treatments — the other options that are available for patients with severe nausea who can’t tolerate pills. That information would have been helpful.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

According to the story, “The most frequent side effects were pain at the site of application along with tingling, itching, warmth and discomfort.” We’ll call this adequate for a satisfactory, but it would have been helpful to know how often these adverse effects occurred, especially since the FDA had previously delayed approval of the product based in part on safety concerns. In addition, there was no mention of other adverse effects that have been associated with triptan use, such as atypical pain and pressure sensations (e.g. tightness in the chest and throat constriction). The story did mention that triptans can be harmful for patients with heart disease or who are taking SSRI antidepressants.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

It’s clear that the evidence consists of placebo-controlled trials that were sufficient to gain FDA approval for the product.

But we look for more.  The patch contains sumatriptan, which is also available in pill, shot and nasal form. How the patch results compare to these formulations seems to be a crucial piece of information to allow readers to assess the quality of the data.  Does the patch work as quickly as the nasal or injection deliveries?  These are pretty key pieces of information that the story could have dug deeper to include.

There was also no independent comment on the significant placebo response:

  • “About half” on the patch achieved eduction in headache after 2 hours vs. 29% on placebo
  • 84% on the patch got nausea relief vs. 63% on placebo

Does the story commit disease-mongering?

Not Satisfactory

Two thoughts give us pause as we think about this criterion.

The story didn’t explore or reference the claim, made by an expert source, that “Migraine patients tend to be underdiagnosed and undertreated and inappropriately treated.” While this pinged on our disease-mongering radar, the available epidemiologic evidence does appear to support this contention. But the story didn’t reference that evidence.

The other, broader question is how often migraine suffers need alternatives to pills. How often is the nausea so bad that the intranasal, injection or patch methods would even be needed? We also can’t be sure – even if migraines are undertreated or inappropriately treated –  whether the patch would do anything to change this. The story mentions that some people have nausea and vomiting so bad that they can’t take a pill, but knowing how many migraine sufferers there are and how many fit that description is the question.

To fail to explore these questions is on the borderline of cheerleading for a new delivery method (the patch) for an old drug (sumatriptan) without reporting on sufficient evidence (data) for true need in comparison with what’s already available.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

Based on a brief Web search, the two expert sources quoted in the story don’t seem to have any conflicts of interest related to this issue.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story mentions alternative delivery systems for migraine medication, including pills, sprays, and injections (although as mentioned above, it doesn’t compare the efficacy of these different approaches). The story could have also mentioned that there are a variety of non-triptan drugs, including NSAID pain relievers, that can be effective for treating acute migraine attacks.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story estimates, from a company source, that this produce will be available toward the end of 2013.

Does the story establish the true novelty of the approach?

Satisfactory

This will be the first skin patch available for delivery of migraine medication, so its novelty isn’t in question.

Does the story appear to rely solely or largely on a news release?

Satisfactory

There is enough original reporting that we can be sure this wasn’t based on a press release.

Total Score: 7 of 10 Satisfactory

Comments (1)

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Linda H

December 20, 2015 at 4:36 am

I am a long time sufferer of frequent (chronic) migraines, up to 15+ a month. I have used sumatriptan since it became available, both in pill form and self-injection. Yesterday I tried the new patch “Zecuity” for the first time (and likely the last). The actual cost per patch is about $300.00. The packaging is ridiculous: a box overnight delivered which was about two feet square with a weight of about 15 pounds. It contained a large, thick styrofoam container, six special, red “PureTemp Bricks”, designed to keep the drug at room temperature (it must be kept between 68 it 77 degrees Fahrenheit–NOT refrigerated), and a box of four patches. The patches themselves contain the medication, but also the “release/delivery” system which includes a computer chip, the red light to indicate activation and completion of medication delivery (four hours–then the light turns off and patch can be removed) and two lithium-manganese dioxide batteries (perchlorate material), which are considered TOXIC WASTE by the federal government and cannot be thrown away in the regular trash. Instructions say to contact your local authorities to inquire how to properly (and legally) dispose of the used patches. The above in and of itself should give most people pause as to whether this is all worth it. But, as anyone who is suffering from a migraine will tell you, the pain and other symptoms are so bad you feel like you’d try practically anything. So, hey, even though this is the same drug, maybe this fancy delivery system is the magic relief we have been searching for. Personally, sumatriptan lessons the duration and severity of my migraines but has never “relieved’ them. It may for some, but not for me. Other than the powerful narcotics I take for other chronic pain, it’s the only other thing that helps at all. Of course, there are strict limits on the number of times it can be used per month for safety reasons, so I can only use it for my worst migraines. The limit on the patches: no more than four per month. So, okay, I decide to give them a try. I followed all of the (somewhat detailed and involved) instructions and “activate it”, apply it, and push the “start” button and the little red light comes on. Within a few minutes, I start to feel a tingling, itchy, burning sensation, though not too bad and certainly not unbearable, or even anything as bad as the pain of the migraine. Within about five minutes, the gel (I assume the medication), starts to ooze out the sides of the patch, making a sticky mess and of course causing the adhesive of the patch to stop working and the thing starts to practically fall off. Okay, the directions say if there are problems with the patch staying in place to use medical tape. So I use medical tape. All around the entire patch I use medical tape. Five minutes later, even the medical tape starts to come loose due to the ozzing gel, so I apply even more tape, a lot of tape. I am also concerned that there is more medicine sticking to the tape than being absorbed into my body. I also only feel, very slightly, any effect of the sumatriptan. I felt a mild burning sensation the entire time the patch was on, as well as red, irritated, itchy, rashy skin upon removal. Oh yeah, and now what the heck do I do with this environmentally hazardous medical waste? Are most users really going to properly dispose of these things? As far a headache relief, obviously intramuscular injection is a quicker way of getting this drug into your body, to provide whatever amount of relief you are going to get from it as quickly as possible. Another consideration: my health insurance required Prior Approval to cover the patches, part of which was a statement from me and my doctor that the other forms of ingestion of sumatriptan (pill, self-injection, intranasal spray) were inadequate and that I required the patches. When I found that out, I refused and told my doctor to do the same. I had little faith that a 4-hour patch of the same drug would work better than a 5 second injection, and I did not want to give up my ability to keep receiving the injections. The drug company provided the one month free trial (four patches), so I agreed to try them. Several years ago, I remember how happy I was when Imetrix finally went generic and I was able to obtain sumatriptan much cheaper. It saved me (and my insurance company) a lot of money. I don’t really want to give that up either. So, I suppose that there are people who may find these patches amazing and effective, especially those who for whatever reason are unable or unwilling to use the self-injections. For me however, considering all of the factors above, I think I’ll stick with the injectable (pun intended), and sometimes the pills, as I don’t like to carry the auto-injections around in my purse (I already have to carry an epipen with me…). I wish the best to other migraine sufferers; perhaps the patches will give them the relief they seek. For me however, they are not the answer.

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