Pharmacy & Therapeutics - October 2008 - (Page 570)

NEW DRUGS NEW DRUGS Immune Globulin (Gamunex) For Rare Neurological Disease The Food and Drug Administration (FDA) has designated an immune globulin product, Gamunex (Talecris Biotherapeutics), as an orphan drug to treat chronic inflammator y demyelinating polyneuropathy (CIDP), a rare auto immune disorder characterized by progressive weakness and impaired sensory function in the legs and arms. CIDP, which affects approximately 25,000 people in the U.S., is caused by an immune system attack on the body’s peripheral nervous system. The effects of CIDP—progressive muscle weakness, loss of deep tendon reflexes, tingling, and numbness—result from damage to the strong, fatty material that covers and protects the ner ve fibers, the myelin sheath. Immune globulin products are obtained from pooled human blood plasma, which contains antibodies that fight infections in patients with compromised immune systems. It is thought that Gamunex improves muscle function by modulating the immune system’s response to the inflammation that damages the myelin sheath, but the exact mechanism is not known. In clinical trials, Gamunex improved some motor functions for up to 48 weeks after the initial treatment. Adverse reactions included headache, fever, elevated blood pressure, rash, joint pain, chills, back pain, nausea, and lightheadedness. (Source: FDA, September 18, 2008, www.fda.gov.) DRUG NEWS then filed suit in the U.S. District Court for the District of Delaware. The trial took place in May 2007. In August 2008, the Court ruled in favor of Barr in challenging Ortho’s patent in connection with Razadyne. The judge denied Janssen’s request to prevent Barr from marketing its product. Ortho-McNeil Neurologics plans to appeal the decision. (Source: Barr Pharmaceuticals, Inc., August 28, 2008.) days of control of nausea and vomiting for patients receiving chemotherapy. If it is left untreated, chemotherapy-induced nausea and vomiting (CINV) can lead to dehydration, malnutrition, treatment delay, or even discontinuation of therapy. With one application of the granisetron patch before chemotherapy, patients receive up to five consecutive days of treatment. Granisetron is delivered via a thin layer of adhesive that attaches the patch to the skin. The FDA approved Sancuso to prevent CINV based on the results of a multicenter phase 3 randomized, doubleblind, double-dummy controlled study comparing the efficacy, tolerability, and safety of the patch with once-daily oral granisetron 2 mg. The patch worked as well as oral granisetron, and complete control of CINV was achieved. Sancuso was generally well tolerated. Adverse reactions occurred in 8.7% of patients. The most common drug-related adverse event was constipation. Application-site reactions were mild and did not lead to discontinuation of use. This approval marks the introduction of ProStrakan Inc. in the U.S. The company is also working with regulator y authorities to bring the patch to market in Europe. (Sources: FDA, www.fda.gov; Web MD, Medscape Medical News, September 15, 2008, www.medscape.com.) NEW INDICATION Gardasil Vaccine for Preventing Vulvar and Vaginal Cancers The FDA has approved Merck’s Gardasil vaccine for preventing vaginal and vulvar cancer caused by human papillomavirus (HPV) types 16 and 18 in girls and women 9 to 26 years of age. These two types cause 70% of cervical cancers and are also known to cause some vulvar and vaginal cancers. Gardasil was originally approved in 2006 to prevent cervical cancer caused by HPV types 16 and 18; precancerous genital lesions caused by HPV types 6, 11, 16, and 18; and genital warts caused by HPV types 6 and 11 in females 9 to 26 years of age. Gardasil does not protect against diseases caused by HPV types not contained in the vaccine, and the data are not sufficient to support the vaccine’s use beyond age 26. The vaccine also does not protect against HPV infections that are already present. Commonly reported adverse events have included fainting, pain at the injection site, headache, nausea, and fever. (Source: FDA, September 18, 2008; www.fda.gov.) Generic Razadyne (Galantamine) Tablets Barr Laboratories, Inc., has received final approval from the FDA to manufacture and market a generic version of Ortho-McNeil Janssen’s Razadyne (galantamine) tablets in strengths of 4 mg, 8 mg, and 12 mg for patients with Alzheimer’s disease. Barr had filed an Abbreviated New Drug Application (ANDA) with the FDA for Razadyne in 2005. However, Janssen Granisetron Patch (Sancuso) To Prevent ChemotherapyInduced Nausea and Vomiting ProStrakan Group has announced the FDA’s approval of Granisetron Transdermal System (Sancuso), the first skin patch to provide up to five consecutive DRUG NEWS No Expanded Uses For Fentanyl (Fentora) The FDA has decided not to allow Cephalon to add a new indication for a 570 P&T® • October 2008 • Vol. 33 No. 10 http://www.fda.gov http://www.medscape.com http://www.fda.gov http://www.fda.gov

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - October 2008

Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.