The US Food and Drug Administration (FDA) today approved a sterile, injectable gel called Solesta (Oceana Therapeutics) to treat fecal incontinence in patients after other remedies have failed.

Solesta, a bulking agent, is injected just beneath the anus lining with the aim of expanding area tissue. When achieved, that expansion narrows the opening of the anus, which may help patients better control their bowel movements, according to the FDA.

The gel is approved for patients aged 18 years and older who have not been helped by diet change, fiber therapy, antimotility medications, or other therapies. It is not indicated for individuals with active inflammatory disease, previous radiation treatment to the pelvic area, and several other conditions and past treatments.

"Fecal incontinence is difficult to treat," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. "This approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies."

An FDA advisory panel last December recommended approval of Solesta on the basis of a clinical trial involving 206 patients in Europe and the United States. After 6 months, more than half of the patients injected with the gelexperienced a 50% reduction in the number of incontinence episodes, according to the FDA. In comparison, one third of patients who received a sham treatment had a similar reduction of episodes.

The most common adverse events associated with Solesta include pain in the injection area and bleeding, according to the FDA. Less common risks are infection and inflammation of anal tissue.

Karen Woods, MD, a member of the FDA advisory panel that issued a green light for Solesta last year, said at the time that "there was a consensus that there were no alarming adverse events, and every event that occurred was resolved or seemed to be successfully treated, and the rate is acceptable."

Solesta is already approved as an injectable treatment for fecal incontinence in Europe and Canada.

The National Institutes of Health estimates that more than 5.5 million Americans experience fecal incontinence.

另外一篇相關報導

FDA的顧問小組建議批准Solesta的腸道失禁的用法

按照預定計劃，諮詢小組於12月²日舉行，討論上市前批准申請（PMA）的Solesta。繼其審查的物業管理公司的數據，小組投票推薦批准。雖然 FDA目前並不需要遵循委員會的建議，它往往如此。

約翰 T. Spitznagel，Oceana的董事長兼首席執行官說，“諮詢委員會的建議，是一個重要的里程碑，對獲得美國批准Solesta為主要不滿意的醫學問題。腸道失禁可以大大損害病人的生活質量，目前許多患者下降分為治療之間存在著差距，保守療法，如飲食控制和更積極的干預，比如手術。“

Solesta是一種注射凝膠已經發展成為在門診的設置管理，而不需要麻醉。 “因此，我們相信Solesta有潛力成為一個重要的治療選擇美國患者排便失禁，說：”Spitznagel。

大衛 S蒂爾尼，醫學博士，Oceana的總裁兼首席運營官，說：“我們很高興與小組的建議，以便核准Solesta並期待著繼續與 FDA進行討論，在餘下的這個監管審查過程。”他進一步指出，“今天宣布的重要進展對美國國會的批准是見證的奉獻，經驗和卓越的Oceana的團隊和我們的工作關係強度與 Q -地中海。”

Oceana的治療取得了全球獨家銷售權 Solesta從 Q -地中海AB公司在2009年6月以來合作進行對照研究，對產品的有效性和安全性。 Solesta採用的Q - Med的專有南沙™技術。