FDA Advisory Panel recommends approval of Solesta for bowel incontinence

Dec 3 2010

Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, today announced that 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, primarily women.

“We are pleased with the Panel's recommendation for approval of Solesta and look forward to continuing discussions with the FDA during the remainder of this regulatory review process.”

As scheduled, the Advisory Panel met on December 2^nd to discuss the Premarketing Approval Application (PMA) for Solesta. Following their review of the PMA data, the Panel voted to recommend approval. Although the FDA is not required to follow Panel recommendations, it often does.

John T. Spitznagel, Oceana's Chairman & CEO, said, "The Advisory Committee's recommendation represents a significant milestone toward obtaining U.S. approval of Solesta for a largely unsatisfied medical problem. Bowel incontinence can substantially impair a patient's quality of life, and currently many patients fall into a treatment gap that exists between conservative therapies such as diet control and more aggressive intervention such as surgery."

Solesta is an injectable gel that has been developed to be administered in an outpatient setting without the need for anesthesia. "Thus, we believe Solesta has the potential of becoming an important treatment option for U.S. patients with bowel incontinence," said Spitznagel.

David S. Tierney, MD, Oceana's President & COO, said, "We are pleased with the Panel's recommendation for approval of Solesta and look forward to continuing discussions with the FDA during the remainder of this regulatory review process." He further noted, "Today's announced key progress toward U.S. approval is a testimony to the dedication, experience and excellence of the Oceana team and the strength of our working relationship with Q-Med."

Oceana Therapeutics obtained the exclusive worldwide marketing rights to Solesta from Q-Med AB in June 2009 and has since collaborated on controlled studies of the product's effectiveness and safety. Solesta utilizes Q-med's proprietary NASHA™ technology.