New Migraine Treatment Approved by FDA Battery Operated

New Migraine Treatment Approved by FDA
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A new migraine treatment approved by the Food and Drug Administration (FDA) runs on a battery. The drug is called Zecuity, and it’s a new delivery system for an old drug, but it is not for everyone who suffers with this often debilitating headache pain and its symptoms.

New migraine treatment comes in a patch

A variety of drugs are available to treat migraine, and one that has been on the market since 1991 is sumatriptan. When it initially became available, sumatriptan was the first drug in the triptan class of prescription medications. Sumatriptan works in the brain by binding to receptors and triggering a reduction in vascular inflammation.

Since its debut as an oral drug, sumatriptan has been approved by the FDA as an injectable drug and in an intranasal inhaler. Soon, sumatriptan will be available in a transdermal patch that delivers one dose of the drug through the skin using a microchip run by a battery.

NuPathe, the company that makes Zecuity, reports that the new treatment option is for adults with migraine with or without aura and is effective in relieving both headache pain and nausea related to migraine. This latter point is especially important, because nausea and vomiting can be as distressing and life-altering as the headache pain.

In fact, the reason some migraine medications are available in non-oral forms such as nasal sprays and injections is that they bypass the gastrointestinal system. These delivery systems, and now the sumatriptan patch, are recommended for patients who experience nausea and vomiting as part of their migraine.

Here are some other things you should know about Zecuity:

  • The patch can be placed on the thigh or upper arm during a migraine. After the patient pushes a button on the ptach, 6.5 mg of sumatriptan is delivered over a four-hour period.
  • The treatment system was approved based on the results of placebo-controlled trials in which 800 patients participated and more than 10,000 patches were used
  • In clinical trials, Zecuity relieved headache pain, migraine-related nausea, and hypersensitivity to light and sound two hours after the patch was activated
  • The most common side effects of Zecuity are pain at the application site, itching, warmth, discomfort, and tingling. Most patients experience skin redness after they remove the patch, but the redness usually disappears within 24 hours.
  • You should not use Zecuity if you have heart disease, history of stroke or heart disease, peripheral vascular disease, transient ischemic attack, blood circulation problems, uncontrolled blood pressure, heart rhythm disturbances, migraines that involve temporary paralysis , basilar migraine, or Wolff-Parkinson-White syndrome
  • Zecuity should not be used if you have taken other migraine drugs within the previous 24 hours
  • Do not use Zecuity if you have taken monoamine oxidase-A inhibitors within the previous two weeks
  • Talk to your doctor before taking Zecuity if you smoke, are postmenopausal, have had seizures, are pregnant or thinking about getting pregnant, or if you have high blood pressure or diabetes

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Other forms of sumatriptan
Sumatripan is available in generic form and is produced and marketed by various pharmaceutical companies under different names, including Alsuma, Imitrex, and Imigran. In addition to the new patch, sumatriptan is available in tablets, nasal spray, and injection.

The nasal spray form of sumatriptan has a recommended dose of 5 mg to 20 mg, with a maximum of 40 mg daily. Some of the side effects associated with the nasal spray are the same as those of other forms of sumatriptan (e.g., dizziness, drowsiness, feeling hot or cold, heavy feeling in the body). However, the nasal spray can also cause a bad taste in the mouth and irritation, numbness, or tingling of the nose and/or throat.

The injectable form of sumatriptan has a recommended dose of 4 mg or 6 mg given under the skin (subcutaneous) using a pen-like device. The maximum dose is two 6-mg injections separated by one hour.

In July 2009, the FDA approved the jet-injector form of sumatriptan, which can be self-administered in the abdomen or thigh. Although the injector is needle-free and helpful for patients who are afraid of needles, it still can cause some pain.

The oral form of sumatriptan is not recommended for individuals who experience nausea and vomiting along with their headache pain. Maximum dosage of oral sumatriptan within a 24-hour period is 200 mg. Oral sumatriptan can be used along with injections with guidance from your doctor and if separated by two hours or as directed by your physician.

According to Armando Anido, CEO of NuPathe, “The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers,” noting that it was especially important for “those with migraine-related nausea.” The new migraine treatment, which should be available by the fourth quarter of 2013, will provide migraine sufferers with yet another option for symptom relief.

SOURCES:
MedicineNet
NuPathe press release
Zecuity website

Image: Morguefile

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