EDISON, N.J.--(BUSINESS WIRE)-- 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,” 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.”
Solesta® is a biocompatible bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta has been developed as a minimally invasive treatment for fecal incontinence. It is the only injectable gel to be administered in an outpatient setting without the need for anesthesia. Solesta is injected in the deep submucosal layer in the proximal part of the anal canal. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal and allowing for better sphincter control.
The Solesta PMA was submitted to the FDA in April 2010 for the treatment of fecal incontinence in adult patients who have failed conservative therapy (i.e., diet, fiber therapy, anti-motility medications). The PMA was reviewed by the FDA’s Gastroenterology and Urology Devices Advisory Panel which met on December 2, 2010 and which voted that Solesta was safe and effective, and that its benefits outweighed its risks.
The main body of clinical evidence in the Solesta PMA submission involved a multi-center, prospective, randomized, Sham (placebo) controlled study of the product’s effectiveness and safety. The study included 206 patients (136 Solesta, 70 Sham) and consisted of a 6-month double-blinded phase followed by an open label phase in which patients originally randomized to Sham treatment were offered Solesta. The primary efficacy objective of the study required: 1) demonstrating a statistically significant Solesta effect after 6 months of treatment; 2) meeting a pre-defined threshold for clinical significance; and 3) showing durability of the Solesta benefit up to 12 months after treatment. All three of these endpoints were met.
Results from this clinical trial of Solesta as a treatment for fecal incontinence were published in The Lancet (March 19, 2011; 377: 997-1003). In general, the authors of the article noted that the treatment not only met its safety and efficacy endpoints, but also was easily applied.
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. 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
* Solesta® is a registered trademark of Q-Med AB of Uppsala, Sweden; Oceana Therapeutics acquired exclusive worldwide sales and distribution rights to Solesta in June 2009.
Stuart Z. Levine, Ph.D., 732-318-3800