HCPLive

FDA Approves Zecuity Skin Patch to Treat Migraine

 
TUESDAY, Jan. 22 (HealthDay News) -- Zecuity, a sumatriptan iontophoretic single-use, battery-powered transdermal system, has been approved by the U.S. Food and Drug Administration for acute treatment of migraine with or without aura in adults.

Noting that migraine patients often present with additional symptoms including migraine-related nausea, Zecuity patches provide an non-oral route of administration. Zecuity patches are applied to the upper arm or thigh and, on activation, initiate transdermal delivery of 6.5 mg sumatriptan over a four-hour period.

The safety and effectiveness of Zecuity were assessed in phase 3 trials that included more than 800 patients who used more than 10,000 patches. After two hours, 18 percent of patients who used Zecuity patches had no more headache, 53 percent experienced some headache relief, and 84 percent had no more nausea. For patients who used a placebo patch, the corresponding figures were 9, 29, and 63 percent. Side effects included application site pain, tingling, itching, and discomfort (5 percent), and triptan-associated adverse events (atypical sensations, 2 percent; pain and other pressure sensations, 2 percent).

"Migraine-related nausea can be as debilitating as migraine headache pain itself," study investigator Stephen D. Silberstein, M.D., of the Jefferson Headache Center in Philadelphia, said in a statement. "Treatments bypassing the gastrointestinal tract may be the best way to treat these patients."
 

More Information

Copyright © 2013 HealthDay. All rights reserved.
 
 

Most Popular

Recommended Reading

GLP-1 receptor antagonists have been associated with thyroid cancer in rodents, and in fact carry a boxed warning about the potential for cancer in humans. This leads many clinicians to ask if they should be concerned about using these drugs in patients who have or develop specific types of thyroid cancer
Dementia is linked to comorbid diabetes and psychiatric conditions like depression, according to research from University College London.
Seizures and other neurological problems traced to pork tapeworms are a new health threat for the US, the CDC reports.
A recent study examined the cost of biologic and non-biologic DMARDs under Medicare Part D and stand-alone coverage plans.
$vAR$