Results Published in The Lancet Demonstrate Fecal Incontinence Symptoms Improve with Bulking Agent Injection
EDISON, N.J.--(BUSINESS WIRE)--Mar 18, 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.
About Oceana Therapeutics
Oceana Therapeutics is committed to commercializing best-in-class therapeutics to address unmet and under-satisfied medical needs with a focus on gastroenterology, urology and other specialty categories. With executive offices in Edison, NJ and European operations headquartered in Dublin, Ireland, Oceana is exceptionally well positioned to pursue worldwide opportunities to acquire and maximize the potential of approved and late-stage specialty therapeutics, including pharmaceuticals, devices, and diagnostics. The Company's lead product, with worldwide sales, is Deflux®, an injectable gel used to treat vesicoureteral reflux. Solesta®, an injectable bulking agent is currently under review by the FDA for US marketing approval for the treatment fecal (bowel) incontinence. A privately held company, Oceana has investment support from the leading venture capital and private equity firms of Kelso & Company and Frazier Healthcare Ventures. For additional information visit www.OceanaThera.com.
Posted: March 2011