Migraineurs who await news of new Migraine treatments will be interested to know that Zecuity TM, a sumatriptan "patch," has now been approved by the Food and Drug Administration (FDA) for the acute treatment of Migraine. In case you're a bit confused, the original working name for this treatment was Zelrix, but it has been changed to Zecuity to avoid confusion with other medications with names that sound similar.
While sumatriptan isn't new (the original brand name is Imitrex), this type of delivery system is emphatically new. It has never been used to deliver any medication before. It's a sumatriptan iontophoretic transdermal system.
Zecuity, is significantly different from other patches. This patch doesn't just sit on the skin and wait for the medication to be absorbed into your skin. NuPathe, the developer of Zelrix, calls it "SmartRelief." SmartRelief is a proprietary iontophoretic system combining modern electronics with state-of-the-art formulation and pharmaceutics technology. Iontophoresis is a non-invasive method for transporting a molecule through the skin by means of a mild electrical current. The electrical current carries the charged molecule from the patch across the skin. Once across, the drug is rapidly absorbed and distributed systemically.
This type of delivery system not only offers quicker relief than oral medications, it has advantages for other reasons as well. For those experiencing nausea and / or vomiting with Migraines, it allows them to avoid oral delivery. Also, some Migraineurs experience gastric stasis during a Migraine attack, which slows the effects of oral medications.
Zecuity preformed well in clinical trials. In the phase 3 pivotal study, twice as many patients treated with Zecuity achieved freedom from headache pain at two hours compared with placebo (18% and 9%, respectively). Additionally, 53% of patients treated with Zecuity achieved relief from headache pain and 84% were nausea free at two hours (29% and 63%, respectively, with placebo). The incidence of triptan-associated adverse events known as "atypical sensations" and "pain and other pressure sensations" was 2% each in Zecuity-treated patients. The most common (greater than 5%) side effects of Zecuity were application site pain, tingling, itching, warmth and discomfort.
Nupathe is now focusing on preparing for the launch of Zecuity in the fourth quarter of this year. You can expect to find it in pharmacies at that time.
What Migraine specialists are saying about Zecuity:
"In addition to severe headache pain, migraine patients present with other significant symptoms, which commonly includes migraine-related nausea. For these patients, physicians need to assess and offer treatments tailored to each individual patient's array of migraine symptoms. In fact, the American Academy of Neurology guidelines recommend a non-oral route of administration for Migraineurs who experience nausea or vomiting as significant symptoms." ~Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache Institute at St. Luke's-Roosevelt Hospital in New York
"Migraine-related nausea can be as debilitating as migraine headache pain itself. Treatments bypassing the GI tract may be the best way to treat these patients." ~study investigator Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia
Summary and comments:
Although we need new medications, especially for patients who cannot take triptan medications such as sumatriptan, the approval of Zecuity is still a major event for Migraineurs who can use triptans, but struggle with medications that are ineffective or less effective with oral delivery systems. The iontophoretic transdermal system marks a new era for those of us who have struggled with oral medications. It will be interesting to see what other medications become available with this delivery system.
I'll be watching for the launch of Zecuity and it's availability in pharmacies later this year and will keep you posted.
NuPathe Inc. Press Release. "NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine." NuPathe Inc. Conshocken, Pennsylvania. January 17, 2013.
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