The results of this study are very positive and promising. It confirms the efficacy and durability of Solesta from the initial studies and establishes the product as a viable treatment option. - Dr. Giovanna da Silva, a specialist in Colorectal Surgery and primary investigator for the study
SANTA BARBARA, Calif. and STOCKHOLM (PRWEB) May 28, 2020
Palette Life Sciences today announces the results and U.S. Food & Drug Administration (FDA) acceptance of the Solesta® post-approval study: "A Prospective, Single-Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (FI)."
The study confirms the treatment benefits previously approved by the FDA, as well as the efficacy, positive impact on QOL, and durability of Solesta treatment effect through 36 months observed in the premarket approval study follow-up.1,2
The new study included 283 subjects across 18 US sites. Notably, the study concluded that:1
- The treatment effect of Solesta is durable and remains statistically significant and clinically meaningful for at least 36 months and over 80% of subjects remained free from FI reintervention at that time point.
- Two separate validated and well-established scales measuring QOL of subjects suffering from FI show a significant improvement in all measured domains from baseline to 36 months post treatment.
- The mean QOL improvement was both statistically and clinically significant in all fecal incontinence QOL categories: lifestyle, coping/ behavior, depression, self-perception and embarrassment.
- Subjects also showed statistically significant reduction in symptoms burden.
- Zero unexpected device or treatment related serious adverse events occurred.
Fecal or bowel incontinence affects millions of people worldwide. The American Society of Colon and Rectal Surgeons (ASCRS) clinical practice guidelines for fecal incontinence states that up to 18% of the general population worldwide suffer from FI.3 However, due to the shame and emotional toll of this condition, many people avoid seeking treatment, and the number of cases is likely higher.4
Healthcare providers and patients can be confident in the demonstrated durability, safety and efficacy through 36 months of Solesta to reduce the number of FI episodes and improve QOL both clinically and statistically.
Solesta is the only FDA-approved minimally invasive treatment for bowel incontinence. It is an injectable, viscous gel made from two polysaccharides; Non-Animal Stabilized Hyaluronic Acid (NASHA®) and unique Dextranomer (Dx) microspheres. The Solesta implant is stable, remains in position and is the only FDA approved injectable gel to be administered in an outpatient setting without the need for anesthesia.2 5,6
“The results of this study are very positive and promising,” said Dr. Giovanna da Silva, a specialist in Colorectal Surgery and primary investigator for the study. “It confirms the efficacy and durability of Solesta from the initial studies and establishes the product as a viable treatment option.”
“This study further confirms that Solesta can have a positive impact for millions of people worldwide who suffer from FI, and showed long term improvement in lifestyle, coping, behavior, depression, self-perception, and the embarrassment often associated with FI,” said Simone Howell, Head of Solesta Development, Palette Life Sciences.
Solesta, a Non-Animal Stabilized Hyaluronic Acid (NASHA) and dextranomer gel, is a tissue bulking agent that is injected into the submucosal layer of the anal canal for treatment of bowel incontinence in adults. It’s a minimally invasive, outpatient procedure that requires no anesthesia and has been proven effective for at least 36 months. Learn more at MySolesta.com.
About Palette Life Sciences
Palette Life Sciences is a fully integrated life sciences company. Its products improve patient outcomes in urology and urogynecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures. Its portfolio of available products includes Deflux®, Solesta® and Barrigel®. Palette Life Sciences moves swiftly to leverage novel applications of existing technologies to create breakthrough solutions. This enables the company to serve those often overlooked by traditional medical companies and improve the quality of life for patients. Led by experienced healthcare executives, Palette Life Sciences is headquartered in Stockholm, Sweden, with offices in Santa Barbara, California, and Dallas, Texas. Learn more at MySolesta.com and palettelifesciences.com.
1. Solesta Post Approval Study Clinical Study Report. December 2019.
2. Solesta [Package Insert]. Santa Barbara, CA: Palette Life Sciences.
3. Paquette IM, Varma MG, Kaiser AM, Steele SR, Rafferty JF. The American Society of Colon and Rectal Surgeons’ Clinical Practice Guideline for the Treatment of Fecal Incontinence. Dis Colon Rectum. 2015;58:623–636.
4. Irwin T, Snow AR, Orton TS, Elliot C. Endoscopic, ultrasonographic, and histologic descriptions of dextranomer/hyaluronic acid in a case of fecal incontinence. Case Reports in Pathology. 2018.
5. Cerwinka WH, Scherz HC, Kirsch AJ. Endoscopic treatment of vesicoureteral reflux with dextranomer/hyaluronic acid in children. Adv Urol. 2008;513854.
6. Graf W, Mellgren KE, et al; for NASHA Dx study group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, shame-controlled trial. Lancet. 2011;377(9770):977-1003.
Solesta® and NASHA® are registered trademarks.