The Lancet publishes Oceana's Solesta injectable gel study results against fecal incontinence

Mar 19 2011

Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, today announced the publication of results from a randomized-controlled clinical trial of the bulking agent, NASHA® DX (brand name, Solesta®), a dextranomer suspended in stabilized hyaluronic acid), which was injected into the submucosa of the anal canal in patients with fecal incontinence. This study of 206 patients aged 18 to 75 from the United States and Europe, published in The Lancet, met primary and secondary endpoints and demonstrated the efficacy and safety of the therapy.

The trial was sponsored by Oceana Therapeutics and Q-Med AB. In June 2009, Oceana Therapeutics obtained from Q-Med AB the exclusive worldwide marketing rights to Solesta and has since collaborated on controlled studies of the product's effectiveness and safety. Solesta, which utilizes the proprietary NASHA technology, has been under development as a minimally invasive treatment for patients with fecal incontinence who have failed conservative therapy. Solesta is an injectable gel administered in an outpatient setting without the need for anesthesia.

In December 2010, the U.S. Food and Drug Administration's (FDA) Gastroenterology and Urology Devices Panel recommended approval of Solesta as a treatment for fecal (bowel) incontinence, a condition afflicting many Americans.

"We are pleased to learn that the authors found that the injectable bulking agent treatment improves fecal incontinence symptoms and that it is easy to apply and safe with few serious adverse effects and that an injectable bulking agent might be used as treatment or as an adjuvant/additional treatment if other treatments do not provide enough relief from fecal incontinence symptoms," said Howard Franklin, M.D., chief medical officer of Oceana Therapeutics. "This means that injectable bulking agents represent an important new option for patients with fecal incontinence and can serve as an intermediary step between conservative therapies such as diet control and more aggressive intervention such as surgery," he added.