FDA issues Approvable Letter for Oceana's Solesta in treatment for bowel incontinence
Published on April 7, 2011 at 9:38 AM
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."
With this letter, FDA has determined that the Solesta Premarket Approval Application (PMA) is approvable subject to certain requirements relative to labeling and manufacturing. Oceana said it welcomes the opportunity to work with the FDA to satisfy, as quickly as possible, the agency's requests for final marketing approval. Also, consistent with Oceana's expectations and plans, the Company will carry out a post-approval study to evaluate long-term treatment data.
"The Solesta PMA was submitted less than a year ago and we are pleased that its progress through the regulatory process is well within our timeline for an anticipated approval and launch this year," said Tierney. "We are excited about Solesta's prospects as a unique treatment for bowel incontinence and are well prepared to provide physicians and patients with product support by leveraging the strengths of our U.S. operating infrastructure and building out a dedicated Solesta sales force."