Document Sample
FDA NEWS Powered By Docstoc
					FDA1108.qxd   11/12/08     12:37 PM      Page 1

      34 Renal & Urology News                     NOVEMBER 2008                                                                                www.renalandurologynews.com

        FDA NEWS                                                                                   Drug Offers Better
        ■ Alpha Blocker Approved for BPH Treatment
        Rapaflo (silodosin), an alpha blocker marketed by Watson Pharmaceuticals, Inc., in
        Corona, Calif., for oral, once-daily treatment of the signs and symptoms of benign
                                                                                                   Glycemic Control
        prostatic hyperplasia (BPH), has received approval. In two phase 3 trials, a daily 8-mg
                                                                                                   Liraglutide found superior to glimepiride
        dose of Rapaflo for 12 weeks resulted in significant, rapid relief of BPH symptoms,
        compared with placebo, as measured by the International Prostate Symptom Score             BY JOHN SCHIESZER
                                                                                                   LIRAGLUTIDE is safe and effec-
        (IPSS). The drug also has been shown to significantly improve maximum urine flow
                                                                                                   tive as once-daily initial pharmaco-
        rates as soon as two hours following the first dose. “Rapaflo is a novel product that
                                                                                                   logic therapy for treating type 2
        provides strong efficacy and an exceptional safety profile for patients managing their
                                                                                                   diabetes, data suggest.
        BPH,” said Paul Bisaro, chief executive officer of Watson. The company expects to            In a study, the drug, a human
        launch Rapaflo in early 2009.                                                              glucagonlike peptide-1 analog, pro-
                                                                                                   duced superior glucose control with
        ■ Company Receives Approval for Anchored Catheter                                          weight loss and little hypoglycemia
        Interrad Medical, Inc., of Plymouth, Minn., has received clearance of its SecurAcath       compared with the long-acting sulfo-
        peripherally inserted central catheter (PICC) with Subcutaneous Securement System,         nylurea, glimepiride, according to data
                                                                                                   from a double-blind phase 3 trial.
                                         which deploys a small anchor in the subcutaneous
                                                                                                   Findings appear in The Lancet (2008;
                                         tissue just beneath the skin to hold an indwelling
                                                                                                   published online ahead of print).
                                         catheter securely in place. Currently, catheters are
                                                                                                     Researchers randomly assigned 746
                                         secured on the surface of a patient’s skin with sutures   patients with early type 2 diabetes to     Alan Garber, MD, PhD
                                         or adhesive devices. The SecurAcath System is             receive once-daily liraglutide (1.2 mg
        designed to improve catheter placement by decreasing catheter maintenance time,            [251 patients] or 1.8 mg [247 pa-          1.2 mg and 1.8 mg, respectively, com-
        reducing infections through better cleaning of the catheter exit site, and minimizing      tients]) or glimepiride 1.8 mg (248        pared with a mean weight gain of
        catheter motion, decreasing skin surface issues, and eliminating needle-stick injuries     patients). At the end of 52 weeks,         1.12 kg with glimepiride. No major
        that may occur during the suturing of catheters. Joe Goldberger, Interrad’s president      hemoglobin A1c (HbA1c) decreased by        hypoglycemic episodes were reported.
                                                                                                   0.51% for the patients on glimepiride      The rate of minor hypoglycemic epi-
        and chief executive officer, commented, “The first placements of the SecurAcath PICC
                                                                                                   compared with 0.84% for patients on        sodes was significantly lower in both
        will begin shortly, followed by worldwide commercialization.” In addition to the current
                                                                                                   liraglutide 1.2 mg and 1.14% for           liraglutide dose groups compared with
        system for PICCs, the company is developing a stand-alone SecurAcath device that
                                                                                                   patients on liraglutide 1.8 mg. Liraglu-   the glimepiride-treated group. The
        can work with all central venous, dialysis, and drainage catheters.                        tide treatment also was associated with    most common GI-related adverse
                                                                                                   greater declines in
Shared By:
Description: A global leader in serving libraries of all types, ProQuest LLC (“ProQuest”) supports the breadth of the information community with innovative discovery solutions that power the business of books and the best in research experience. More than a content provider or aggregator, ProQuest is an information partner, creating indispensable research solutions that connect people and information. Through innovative, user-centered discovery technology, ProQuest offers billions of pages of global content that includes historical newspapers, dissertations, and uniquely relevant resources for researchers of any age and sophistication—including content not likely to be digitized by others.
ProQuest creates specialized information resources and technologies that propel successful research, discovery, and lifelong learning.