Palette Life Sciences Receives Favorable Post Approval Study Results for Solesta®
SANTA BARBARA, Calif. and STOCKHOLM, Sweden, March 29, 2022— Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced the results of their Solesta® Post Approval Study (PAS). Solesta is the only FDA-approved minimally invasive treatment for fecal incontinence (FI). The study was a requirement of the Food and Drug Administration (FDA) approval process and was designed to supplement the results of previous Solesta trials. The primary aim of the study was to evaluate the efficacy and safety of Solesta for treating FI through 36 months. The prospective, single-arm study followed a population of 283 patients and determined that Solesta provided clinically significant, sustained improvement in symptoms and quality of life, without the occurrence of any serious adverse events.1
Significant improvement for patients who received Solesta was documented using the Cleveland Clinic Fecal Incontinence Score (CCFIS) and Fecal Incontinence Quality of Life subscales (FIQL) on all domains. The data also showed that 80% of treated patients did not require further intervention at 36 months.1
“The post approval study data further supports Solesta’s safety and efficacy profile seen in previous trials. Solesta has helped thousands of patients who suffer from fecal incontinence by significantly improving their quality of life and reducing the disease burden. This robust clinical data provides physicians and their patients confidence in choosing Solesta as a treatment option for FI,” said Simone Howell, Director of Medical Affairs, Palette Life Sciences.
Fecal incontinence affects up to 18% of the general population worldwide and is most prevalent in adults over the age of 65.2 The prevalence of FI continues to rise as the proportion of adults over 65 increases. Due to the emotional toll of this condition, and the perception of ineffective treatments, many patients with the condition avoid seeking treatment meaning prevalence is likely higher. 3
Solesta is an FDA-approved, minimally invasive injectable made from two polysaccharides: Non-Animal Stabilized Hyaluronic Acid (NASHA®) and unique Dextranomer (Dx) microspheres. All of Palette Life Sciences’ products leverage their global rights to NASHA, a proprietary hyaluronic acid formulation that has been proven safe and effective and used for more than 20 years in over 50 million medical procedures worldwide.4
“The positive results of this trial provide confidence in a minimally invasive treatment for patients after the initial conservative management of fecal incontinence, and before evaluating a more invasive intervention,” said Lieschen Quiroz, MD and OB/GYN Urogynecologist at the University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma. “It was exciting to evaluate a treatment option that may help more patients take control of their fecal incontinence.”
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 fecal 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. Palette Life Sciences’ products improve patient outcomes in urology and urogynecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures. The company’s portfolio of available products includes Barrigel®, Deflux®, Solesta®, and Lidbree™. Palette Life Sciences moves rapidly to leverage novel applications of existing technologies to create breakthrough medical solutions. This focus enables the company to serve those often overlooked by traditional medical companies and improve patient quality of life. Led by experienced healthcare executives, Palette Life Sciences is headquartered in Stockholm, Sweden, with offices in Santa Barbara, California, Dallas, Texas, Sydney, Australia, and Tokyo, Japan. Learn more at http://www.palettelifesciences.com.
- Quiroz, Lieschen H. M.D.1; Galliano, Domingo E Jr. M.D.2; da Silva, Giovanna M.D.3; Carmichael, Joseph C. M.D.4; Pan, Li-Chen M.P.H.5; Bromley, Emilie R. M.P.H.5; Hinahara, Jordan B.A.5; Goss, Thomas F. Pharm.D.5 Efficacy and Safety of a Non-animal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence, Diseases of the Colon & Rectum: January 4, 2022 – Volume – Issue – doi: 10.1097/DCR.0000000000002348
- 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.
- 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.
- Galderma. Restylane. Available at https://www.galdermaaesthetics.com/science-behind-restylane. Accessed January 24, 2022.