New York Headache Center

In addition to an injection, tablet and a nasal spray, sumatriptan is being tested in two other formulations.  No, it is not an inhaled form, which I just posted in my previous blog (dihydroergotamine inhaler), but through a skin patch and by a “lingual spray”, that is a spray into the mouth.  The skin patch may work fast and will deliver medicine through the skin, bypassing the stomach, which would be very useful for people who get very nauseous and have difficulty swallowing medications.   However, it is quite a large patch and will probably cost significantly more than a tablet, particularly in the generic form.  The second new formulation, a spray into the mouth, appears to partially absorb in the mouth and partially in the stomach, making it also work faster, although so far it looks to be only as effective as a 50 mg tablet.  The usual dose is 100 mg.  Also, hopefully the company that is developing this product has been able to mask the taste of sumatriptan.  Patients who have tried the nasal spray often complain of a very unpleasant taste, which can make nausea worse.

Trials of an inhaled version of an old migraine drug show surprisingly good results.  The drug is dihydroergotamine and in injectable from is considered to be one of the strongest migraine medications.  It is often used intravenously to treat severe migraines that do not respond to other therapies and for medication overuse headaches.  It can be also injected into the muscle, under the skin or sprayed into the nose.  The main problem with this drug is that it often makes nausea worse or even causes severe nausea in patient who do not have it.  What is surprising about the new product being developed by MAP Pharmaceuticals (to be called Levadex if and when FDA approves it) is not that is is very effective, but that it causes significantly less nausea than the same drug in an injectable form.  Another advantage is that inhaling the medicine into the lungs results in a very quick delivery of the drug into the circulation - as quick as an injection but without a needle.  A similar product, Ergotamine Medihaler was available until about 15 years ago, but was withdrawn because of manufacturing difficulties and limited demand.  The demand for this new product will also be limited because it will be more expensive than a tablet of any migriane drug, it will be more bulky to carry around, and will be mostly utilized by patients who cannot take oral medications due to nausea or by those who need very quick onset of action to abort an attack.

Lower facial pain during a migraine attack occurs in 9% of migraine patients, according to a recent report published in Cephalalgia by German researchers.  One of the 517 migraine patients they looked at had lower facial pain as the leading symptom of migraine.  Some of my patients with lower facial pain wonder if they have a disorder of the temporo-mandibular joint (TMJ).   Some of them do benefit from an oral appliance that reduces grinding and clenching, in most however, a successful treatment of their migraines with abortive or prophylactic medications will often relieve the jaw pain as well.

Imitrex and Topamax are two migraine medications that recently lost their patent protection and became available in a generic form, under the names of sumatriptan and topiramate.  Many patients are concerned about the quality of generic products.  A recent study published in Neurology looked at 948 patients with epilepsy who were treated with generic Topamax (it is approved for the treatment of both migraines and epilepsy).  Compared to patients who used the branded Topamax, those on generic substitutions needed to have more of other medications, were admitted to the hospital more frequently and stayed in the hospital longer.  The risk of head injury or fracture (presumably due to seizures) was almost three times higher after the switch to a generic drug.

Clearly, migraine patients do not run the same risk as epilepsy patients of having a seizure or being admitted to the hospital, however a small number of patients can have worsening of their migraines.  The main reason is the legally permitted variation in the amount of medicine in each tablet.  Taking a higher dose of the generic drug can help.

The same applies to Imitrex - a small number of patients will find that the generic sumatriptan is slightly less effective.  The only, albeit significant, advantage of the generic drugs is cost savings.  At this point we have only one generic substitution for Imitrex and the price difference is only 20%, but in a few months more generics will appear and the price should drop significantly, which is a very welcome development for patients with frequent migraines.