FDA clears faecal incontinence gel

The US Food and Drug Administration (FDA) has approved Oceana Therapeutics' Solesta, an injectable treatment for faecal incontinence in adult patients who have failed other treatments, such as diet change, fibre therapy or anti-motility medications.

Oceana will conduct a post-approval study to evaluate long-term treatment data for the product, as the approval was based on a study that enrolled only 206 patients and yielded data that was complicated by a high response rate in the placebo group. After six months, more than half of the patients in the treatment group had a 50 per cent reduction in the number of faecal incontinence episodes. However, one-third of patients in the placebo group had a similar reduction.

The company submitted its marketing application for the injectable gel in April 2010 and received an approvable letter from the FDA last month indicating that final approval could be granted after the resolution of certain relatively minor concerns related to labelling and manufacturing. The FDA's decision on the product followed a positive recommendation from its Gastroenterology and Urology Devices Advisory Panel in late 2010.

Solesta was licensed by Oceana from the medical device company Q-Med AB "to address the large treatment gap that exists between conservative therapies for bowel incontinence such as dietary control and more complicated, invasive treatments such as surgery," according to the company.

The product is a biocompatible bulking agent made of dextranomer microspheres and stabilised sodium hyaluronate. It is injected into a layer of tissue beneath the anus lining in an outpatient setting without the need for anaesthesia. In the clinical study, most patients received eight injections, delivered over two treatment sessions.

According to the FDA, the gel likely works by building up tissue in the area surrounding the anus, thereby narrowing the opening of the anus and providing greater muscular control for the patient.

"Faecal 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 faecal incontinence that does not respond to conservative therapies."

Oceana said it would support the product launch by building a dedicated Solesta sales force. The privately owned company, which is headquartered in New Jersey, was founded in 2008 with a focus on buying late-stage investigational therapies for colorectal, gastroenterology and urological diseases and bringing them to market.

Currently, the company's only marketed product is an injectable gel used to correct a malformation of the urinary bladder in children. That product, known as Deflux, was licensed from Q-Med in 2009 through the global agreement between the companies that also involved Solesta.