The benefits of Solesta (Oceana Therapeutics Inc), a bulking agent intended to prevent fecal incontinence, outweigh its risks, according to a 5 to 0 vote (with 1 abstention) of a US Food and Drug Administration (FDA) advisory panel yesterday.The Gastroenterology and Urology Devices Advisory Committee vote supported the approval of Solesta for adult patients with fecal incontinence who have failed conservative therapy.
Solesta is a bulking agent that is injected submucosally in the proximal part of the high-pressure zone of the anal canal. For each treatment, a series of 4 equally spaced injections with 1 mL of Solesta is performed approximately 5 mm proximal to the dentate line, with the aim of expanding the submucosal layer in the distal anal canal and thereby improving bowel control.
The FDA panel based its recommendation on data from a randomized, blinded, placebo-controlled study conducted at 13 centers in the United States and Europe. A total of 206 patients, aged between 18 and 75 years, were included. Each had experienced at least 4 episodes of fecal incontinence during the previous 2 weeks and had failed other, more conservative preventive approaches, such as dietary modification.
Patients were randomly assigned to receive either Solesta or a sham treatment for 6 months, after which time all patients received treatment with Solesta and were followed-up for an additional 6 months.The primary efficacy endpoint was a 50% decrease in incontinence episodes. After 12 months, 53% of patients receiving Solesta met this endpoint compared with 31% of sham patients (P < .05).Continued Reduction in Fecal Incontinence at 12 Months.
In a premeeting report presented to the FDA, the manufacturers concluded that the data show a clinically meaningful reduction in fecal incontinence episodes that was sustained for at least 12 months after treatment.
The panel also voted 6 to 0 in favor that the agent is safe for the treatment of fecal incontinence in adult patients who have failed conservative therapy. Safety data were obtained on 136 patients treated with Solesta for up to 12 months and on 70 patients randomly assigned to receive sham treatment in the blinded phase of the study.Nearly all adverse events were mild to moderate intensity, although anal or rectal abscesses were noted in 4 patients who received active treatment (none occurred in participants receiving sham treatment). Most adverse events associated with Solesta occurred within the first 6 months; 9 events occurred after 6 months, and all were mild intensity except for 1 case of proctalgia, which was moderate.
Patients receiving the agent also experienced a statistically significant improvement in quality of life, as per 2 quality of life measures: the Fecal Incontinence Quality of Life Scale and the Cleveland Clinic Fecal Incontinence Score.In addition, although the data were drawn from patients who were disproportionately white and women, the panelists generally agreed that these results could be extrapolated to other demographic groups.
Deflux, the material used in Solesta, was approved in the United States in 2001 for treatment of children with vesicoureteral reflux grades II to IV. Solesta is already approved for use in Europe and Canada as an injectable treatment for fecal incontinence.At this time, the only approved implantable medical device in the United States for fecal incontinence is the Acticon Neosphincter. In addition, the SECCA device is a 510(k)-cleared radiofrequency ablation device.Noninvasive therapies for fecal incontinence include techniques such as dietary modification, antidiarrheal medication, and biofeedback. More invasive surgical treatments include sphincteroplasty or sphincter repair, implantation of an artificial bowel sphincter, radiofrequency ablation of the tissue of the anal canal, and ileostomy/colostomy surgical repair.