FDA approves first migraine patch
FDA has approved sumatriptan iontophoretic transdermal system (Zecuity, NuPathe) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin.
Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN). Migraine is a neurological disorder that affects approximately 30 million adults in the United States.
Zecuity is applied to the upper arm or thigh during a migraine. Following application and with a press of a button, Zecuity initiates transdermal delivery, bypassing the gastrointestinal tract. Throughout the 4-hour dosing period, the microprocessor within Zecuity continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of sumatriptan.
Back in August 2011, FDA issued a complete response letter (CRL) to NuPathe regarding the New Drug Application for its migraine patch. According to a NuPathe press release, the CRL primarily contained chemistry, manufacturing, and safety questions.
"The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers. As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea,” Armando Anido, CEO of NuPathe, said in a press release.
"In addition to severe headache pain, migraine patients present with other significant symptoms, which commonly includes migraine-related nausea," said Lawrence C. Newman, MD, FAHS, FAAN, director of the Headache Institute at St. Luke's-Roosevelt Hospital in New York. "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."
Zecuity was approved based upon an extensive development program with phase 3 trials that included 800 patients using more than 10,000 Zecuity patches. In these trials, Zecuity was proven safe and effective at treating migraine and relieving its cardinal symptoms (headache pain, migraine-related nausea, and sensitivity to light and sound) 2 hours after patch activation.
In the phase 3 pivotal study, twice as many patients treated with Zecuity achieved freedom from headache pain at 2 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.