Oceana Therapeutics out of Edison, New Jersey won FDA approval for its Solesta injectable gel for treatment of fecal incontinence in patients for whom a change in diet, fiber therapy, or anti-motility medication has not helped. The gel is injected into the anus lining, helping to build tissue in the area and thus narrow the opening.
More about Solesta from the product page:
- Solesta is a biocompatible bulking agent that is injected into the submucosal layer of the anal canal.
- Solesta provides a framework for the fibrin and collagen within the submucosal layer to adhere to, eventually forming a durable and tissue-like narrowing of the anal canal.
- 42.7% reduction in fecal incontinence episodes in just 3 months
- Marked improvements in all 4 categories of the Fecal Incontinence Quality of Life assessment
- Dependable, durable efficacy for up to 24 months
- Injecting Solesta takes approximately 10 minutes in an outpatient setting and does not require anesthesia
- Solesta is injected via simple anoscopy with minimal postprocedure impact on patients
- Solesta was well tolerated in an 18-month clinical trial—96% of adverse events were classified as mild or moderate and 97% of the events required no interventions or required medical or simple non-invasive interventions
Product page: Solesta …
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