Pharmacy & Therapeutics - September 2008 - (Page 513)

NEW DRUGS NEW DRUGS Rapid-Acting Clevidipine (Cleviprex) for Hypertension The U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) injectable emulsion clevidipine butyrate (Cleviprex, The Medicines Company) to reduce blood pressure when oral therapy is not feasible or desirable. A calcium-channel blocker, clevidipine is metabolized in the blood and tissues and does not accumulate in the body. For more information on clevidipine, please see this month’s Pharmaceutical Approval Update column on page 550. (Sources: The Medicines Company, August 4, 2008; www.cleviprex.com.) DRUG NEWS NEW INDICATIONS Tenofovir (Viread) For Chronic Hepatitis B Gilead Sciences has announced the FDA’s approval of tenofovir disoproxil fumarate (Viread) for treating adults with chronic hepatitis B. Administered as a once-daily tablet, tenofovir blocks an enzyme necessary for the virus to replicate in liver cells. Tenofovir has been available in the U.S. as a therapy for HIV infection in adults since 2001. The approval was based on data from two ongoing phase 3 trials that compared tenofovir with Gilead’s adefovir dipivoxil (Hepsera) over 48 weeks. Results from both studies show that a greater percentage of patients with chronic hepatitis B who received tenofovir achieved a complete response to treatment compared with those receiving adefovir. Trial participants included both patients new to HBV therapy and patients who had received prior nucleoside treatment. (Source: FDA, August 13, 2008.) Romiplostim (Nplate) For a Bleeding Disorder Amgen has been granted approval to market romiplostim (Nplate) for treating a chronic bleeding disorder. This is the first product that directly stimulates the bone marrow to produce needed platelets. A weekly injection treats immune thrombocytopenic purpura (ITP), which causes the immune system to attack the platelets, making patients vulnerable to bruising and severe bleeding. In company studies, Nplate helped 56% of patients sustain a healthy number of platelets in the blood for six months. The drug worked 38% of the time in patients whose spleens had been removed; however, none of these patients did well with placebo. More studies are needed to determine whether leukemia is more likely to develop in patients with myelodysplasia who receive Nplate. (Source: Bloomberg News, August 22, 2008.) Huntington’s disease some measure of relief from chorea, the symptom that symbolizes the disease for many people. Tetrabenazine (Xenazine, Prestwick) is the first treatment of any kind approved in the U.S. for any symptom of Huntington’s disease, an inherited neurological disorder in which degenerating brain cells cause uncontrolled movements. The drug reduces the amount of dopamine available to interact with certain nerve cells. In one trial, treated patients showed significant improvements in chorea, compared with placebo patients. The drug reduced chorea in the short term, but patients also showed slight worsening in mood, cognition, rigidity, and functional capacity. Although tetrabenazine brings hope to patients and their families, it has serious side effects, including depression and suicidal thoughts and actions. Tetrabenazine has been approved with a Risk Evaluation and Mitigation Strategy, which includes educational materials. The FDA requires that the guide be handed out with every prescription dispensed. (FDA , August 15, 2008.) DRUG NEWS 2008–2009 Influenza Vaccines The FDA has approved this year’s seasonal flu vaccines, including new strains of the virus likely to cause flu in the U.S. during the 2008–2009 season. The six vaccines are Afluria (CSL Biotherapies), Fluarix (GlaxoSmithKline), FluLaval (ID Biomedical/GlaxoSmithKline), FluMist (MedImmune), Fluvirin (Novartis), and Fluzone (Sanofi Pasteur). The vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the U.S. Each season’s vaccines are modified to reflect the virus strains most likely to be circulating. The closer the match between the circulating strains and the strains in the vaccines, the better the protection. Even if the match is not exact, the vaccines may reduce the severity of the illness and may prevent flu- Generic Depakote (Divalproex) The first generic versions of Abbott’s divalproex sodium (Depakote) delayedrelease tablets have been approved. Depakote is indicated for the treatment of seizures, bipolar disorder, and migraine headaches. The generic tablet has the same safety information as Depakote, including a boxed warning that cautions about the risk of liver damage, pancreatitis, and birth defects. Sun, Genpharm, Nu-Pharm, UpsherSmith, Sandoz, Teva, Dr. Reddy’s, and Lupin have received approval to market the tablets. (Source: FDA, July 31, 2008.) Tetrabenazine (Xenazine): First Drug for Huntington’s Chorea For the first time, a treatment has been approved that may give patients with Vol. 33 No. 9 • September 2008 • P&T® 513 http://www.cleviprex.com

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Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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