Injectable gel for fecal incontinence
Company: Oceana Therapeutics
Pharmacologic class: Tissue-bulking agent
Active ingredient: Dextranomer microspheres 50 mg/mL, sodium hyaluronate 15 mg/mL; gel for submucosal injection.
Indication: Treatment of fecal incontinence in patients who have failed conservative therapy (e.g., diet, fiber therapy, antimotility drugs).
Pharmacology: Solesta is a biocompatible tissue-bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. While the exact mechanism of action has not been identified, it is hypothesized that Solesta may narrow the anal canal and allow for better sphincter control.
Clinical trials: Clinical data supporting the safety and effectiveness of Solesta are available from three clinical studies. The main body of clinical evidence came from a multicenter, prospective, randomized, placebo-controlled study of the product's effectiveness and safety.
The study included 206 patients (136 Solesta, 70 placebo) and consisted of a six-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: (1) demonstrating a statistically significant Solesta effect after six months of treatment; (2) meeting a predefined 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. Additionally, patients have been followed for more than two years, and the corresponding data showed no decline in effectiveness.
Adults: See literature. Bowel preparation of rectum using enema required prior to injection. Prophylactic antibiotics are recommended. Inject slowly in deep submucosal layer in the proximal part of the high-pressure zone of the anal canal about 5 mm above the dentate line.
Four 1-mL injections are to be given in the following order: posterior, left lateral, anterior, right lateral. Keep needle in place for 15 to 30 seconds to minimize leakage. A new needle should be used for each syringe and injection site.
Post-treatment: Avoid hot baths and physical activity during first 24 hours, antidiarrheal drugs, sexual intercourse, strenuous physical activity for one week, anal manipulation for one month. Retreatment: If needed, may repeat with maximum 4 mL no sooner than four weeks after first injection. Point of injection should be made in between initial injections, shifted one-eighth of a turn.
Children: <18 years: not recommended.
Contraindications: Active inflammatory bowel disease. Immunodeficiency disorders or ongoing immunosuppressive therapy. Previous radiation treatment to the pelvic area. Significant mucosal or full-thickness rectal prolapse. Active anorectal conditions (e.g., abscess, fissures, sepsis, bleeding, proctitis, other infections). Anorectal atresia, tumors, stenosis or malformation. Rectocele. Rectal varices. Presence of existing implant in anorectal region.
Warnings/Precautions: Used by clinicians experienced in anorectal procedures who have successfully completed training and a certification program in Solesta injection procedure. Do not inject intravascularly; may cause vascular occlusion. Avoid injecting in midline of anterior wall of rectum in men with enlarged prostate. Complete external sphincter disruption. Significant chronic anorectal pain. Previous anorectal procedures. Bleeding diathesis. Pregnancy. Nursing mothers.
Interactions: Concomitant anticoagulants, antiplatelets: increased risk of bleeding at injection site.
Adverse reactions: Anal hemorrhage, anorectal discomfort, chills, diarrhea, injection site hemorrhage, pain.
How supplied: Syringe (1 mL) — 4 (with needles)
For more information, call 732.318.3800 or visit www.Solestainfo.com. n