Solesta
Application Filed for New Treatment for Incontinence
On April 12, 2010 Oceana Therapeutics and Q-Med AB announced the filing of a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for Solesta® for the treatment of Bowel Incontinence, a largely unsatisfied medical need afflicting millions of Americans.
Solesta, which has been under development as a minimally invasive treatment for patients who have failed conservative therapy, is an injectable gel administered in an outpatient setting without the need for anesthesia. Oceana Therapeutics and Q-Med AB have collaborated on a multi-center, prospective, randomized, placebo controlled study of the product’s effectiveness and safety.
The pivotal study, representing the main body of clinical evidence in the PMA submission, involved 206 patients (136 Solesta, 70 placebo). The study consisted of a 6-month double-blinded phase followed by an open label phase in which patients originally randomized to placebo treatment were offered Solesta. The primary efficacy objective of the study required:
- demonstrating a statistically significant Solesta effect after 6 months of treatment;
- meeting a pre-defined threshold for clinical significance; and
- showing durability of the Solesta benefit up to 12 months after treatment.
All three of these endpoints were met.
Tracy Hull, MD, Professor of Surgery, Digestive Disease Institute, Colon and Rectal Surgery at the Cleveland Clinic in Cleveland OH, and a Solesta principle investigator, commented, “This is a significant medical problem that can greatly diminish a patient’s quality of life. Moreover, there is a large treatment gap between conservative therapies for fecal incontinence such as dietary control – with or without medical therapy – and more involved treatments such as surgery. Our clinical experience with this novel injectable material suggests that it may be a useful option for patients who fail conservative therapy.”
FDA approval of a PMA is required before a product can be marketed. The FDA bases a PMA approval on a determination that the application contains sufficient valid scientific evidence of safety and effectiveness for the intended use.