FDA issues Approvable Letter for Oceana's Solesta in treatment for bowel incontinence

Published on April 7, 2011 at 9:38 AM · No Comments

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 (FDA) has issued an Approvable Letter for Solesta® as a treatment for fecal (bowel) incontinence.

“This is a particularly important development indicating the potential near-term U.S. marketing approval of what we consider to be a one-of-a-kind treatment option for bowel incontinence, a condition afflicting numerous Americans”

"This is a particularly important development indicating the potential near-term U.S. marketing approval of what we consider to be a one-of-a-kind treatment option for bowel incontinence, a condition afflicting numerous Americans," noted John T. Spitznagel, Oceana's Chairman & CEO. "The loss of bowel control is a life-limiting condition that can cause severe patient embarrassment and even social withdrawal."

Solesta has been developed by Oceana in collaboration with 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. "Solesta truly addresses an unmet medical need," said David S. Tierney, MD, Oceana's President & COO. "Moreover, as the only minimally invasive injectable gel to treat bowel incontinence, Solesta offers the distinct advantage of being administered, relatively quickly, in an outpatient setting without the need for anesthesia."

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