Zecuity

By , 2013年1月22日 7:33 AM

片頭痛で面白そうな治療が FDAに承認されました。

パッチを貼って、薬剤を投与したいときにボタンを押すと、持続的に皮膚抵抗を感知しながら 4時間に渡り、スマトリプタン 6.5 mgを経皮的に注入してくれるのだそうです。高そうなパッチに見えますが、単回使用で使い捨てです。

このニュースを読んで感じたのは、群発頭痛の患者さんに使えないかなということです。私は群発期の明け方の激しい頭痛に対し、半減期の長いナラトリプタン (アマージ) を眠前に飲んでもらって翌朝の頭痛を軽減することがありますが、それでも寝る前に飲んだナラトリプタンの薬効が切れてから頭痛発作が始まる場合があります。そうした患者さんでは、頭痛を避けるために夜中に一回起きて薬を飲んでから再度寝たりしています (ナラトリプタンは群発頭痛に対して保険適応はありませんが、頭痛を専門に診ている医師なら、このような使い方を試した医師は少なくないのではないかと思います)。このパッチにタイマーをつけて、午前 4時くらいからスマトリプタンが徐々に注入されるようにすれば、明け方の発作が軽減できる可能性があるのではないかと思うのです。このパッチが日本で使えるようになれば、検討してみると面白いかも・・・。どっかの会社がやってみないかなぁ。

あと、記事にはなかったけれど、生物学的利用率はどのくらいなのでしょうか。スマトリプタンは、経口だと 15%, 皮下注射だと 96%と、大きく異なりますので、パッチだとどうなのか気になります。

January 17, 2013 18:17 ET

NuPathe’s Zecuity Approved by the FDA for the Acute Treatment of Migraine

First FDA-Approved Migraine Patch

Conference Call Scheduled January 18 at 8:30 a.m. EST

CONSHOHOCKEN, PA–(Marketwire – Jan 17, 2013) – NuPathe Inc. (NASDAQ: PATH) today announced that the U.S. Food and Drug Administration (FDA) has approved Zecuity™ (sumatriptan iontophoretic transdermal system) 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).”The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers,” said Armando Anido, CEO of NuPathe. “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. We thank the patients and physicians who participated in our clinical trials as well as our employees for their support throughout the development of Zecuity. We now intensify our focus to securing commercial partners and preparing for the launch of Zecuity expected in the fourth quarter of this year.”

“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.”

“Migraine-related nausea can be as debilitating as migraine headache pain itself,” said study investigator Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia. “Treatments bypassing the GI tract may be the best way to treat these patients.”

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) two hours after patch activation.

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.

About Zecuity
ZECUITY™ (sumatriptan iontophoretic transdermal system) is indicated for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch applied to the upper arm or thigh during a migraine. Following application and with a press of a button, Zecuity initiates transdermal delivery (through the skin), bypassing the gastrointestinal tract. Throughout the four-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, the most widely prescribed migraine medication, with minimal patient-to-patient variability.


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