US-based Salix Pharmaceuticals has 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).
Salix Pharmaceuticals president and CEO Carolyn Logan noted 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" Logan added.
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.
DEFLUX is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.
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.
It 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 6ml of DEFLUX (3ml at each ureteral orifice) at the same treatment session, and treatment of children under one 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 (for example, 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.
