Salix Pharmaceuticals, Ltd. today announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the Deflux ® premarket approval (PMA) supplement, which requested approval of labeling changes to add two additional techniques for injection, a single intra-ureteric injection (HIT procedure) and a double (proximal and distal) intra-ureteric injection (Double-HIT procedure).
“Deflux ® has always been an effective, minimally invasive option for children suffering from vesicoureteral reflux grades II-IV. This approval and update to the Deflux ® labeling provides pediatric urologists even more confidence to offer Deflux to families,” said Carolyn Logan, President and CEO of Salix.
Several techniques have been described for the endoscopic treatment of vesicoureteral reflux (VUR) including a subureteric injection (STING procedure), the HIT procedure and the Double-HIT procedure. The Double-HIT procedure is a refinement of the original STING and HIT procedures and has been reported to result in greater clinical success rates.
“Our experience has shown that there is a correlation between the location of the injection and physician experience with greater Deflux ® success rates. This update recognizes the evolution of the endoscopic technique and I believe it may improve the results following a single Deflux ® injection,” said Dr. Andrew Kirsch, Chief of Pediatric Urology at Children’s Healthcare of Atlanta and Professor of Urology at Emory University School of Medicine.
Indication for DEFLUX DEFLUX is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.
Important Safety Information about DEFLUX DEFLUX ® (hyaluronic acid/dextranomer) is contraindicated in patients with any of the following conditions: non-functional kidney(s), hutch diverticulum, ureterocele, active voiding dysfunction, and ongoing urinary tract infection.
DEFLUX must not be injected intravascularly as injection into blood vessels may cause vascular occlusion.
DEFLUX should only be administered by qualified surgeons experienced in the use of a cystoscope and trained in subureteral injection procedures.
Safety and efficacy of treatment of duplex systems, use of more than 6 mL of DEFLUX (3 mL at each ureteral orifice) at the same treatment session, and treatment of children under 1 year of age have not been established.
Ureters with grossly dilated orifices may render the patient unsuitable for treatment.
There is a risk of infection and bleeding that is associated with the cystoscopic procedure used to inject DEFLUX. The usual precautions associated with cystoscopy (e.g., sterile technique, proper dilation, etc.) should be followed.
The safety of DEFLUX in the treatment of VUR is based on a randomized study in which 39 children were treated with DEFLUX for VUR, and two nonrandomized studies in which 170 children were treated with DEFLUX for VUR. Treatment-related adverse events from the randomized and the nonrandomized studies were: urinary tract infection (UTI), ureteral dilation, and nausea/vomiting/abdominal pain.
The following adverse events have been reported with Deflux: ureteral obstruction (some cases requiring temporary placement of a ureteric stent), dysuria, hematuria, urgency, frequency, hydronephrosis, pyelonephritis, urinary tract infection, foreign body reaction, calcification and pyrexia.