Pharmacy & Therapeutics - February 2009 - (Page 67)

NEW DRUGS NEW DRUGS Fenofibric Acid (TriLipix) Plus a Statin for Cholesterol The FDA has approved Abbott’s fenofibric acid (TriLipix) delayed-release capsules along with diet to help lower triglyceride and low-density lipoproteincholesterol levels (LDL-C) and to raise high-density lipoprotein-cholesterol (HDL-C) levels. This is the first fibrate to be approved for use with a statin, although it has not been shown to prevent heart disease or heart attack. In studies of patients with mixed dyslipidemia, fenofibric acid plus a statin— rosuvastatin calcium (Crestor, AstraZeneca), atorvastatin (Lipitor, Pfizer), or simvastatin (Zocor, Merck)—improved all three key lipids better than the corresponding therapies alone. TriLipix is discussed in this month’s Pharmaceutical Approval Update feature, page 86. Source: FDA, December 24, 2008 DRUG NEWS ogy provides rapid absorption from the oral mucosa. Because of its rapid onset of action, the spray should be used right before bedtime. Patients should be prepared to get a full night’s sleep of seven to eight hours, and they should avoid activities requiring full alertness the next morning. This product should not be taken with alcohol. Patients who have taken sedative– hypnotic medications have reported sleepwalking, driving or eating while not fully awake, and amnesia for the event. Sources: FDA, www.fdanews.com; NovaDel, www.novadel.com Degarelix for Prostate Cancer Degarelix (Ferring/Rentschler) is the first new injectable drug developed in several years for treating advanced prostate cancer. This gonadotropin-releasing hormone (GnRH) receptor inhibitor slows the progression of prostate cancer by suppressing testosterone. Hormonal treatments for prostate cancer may cause an initial surge in testosterone production before the hormone level is reduced. This initial stimulation of the hormone receptors may temporarily promote tumor growth rather than inhibit it; however, degarelix does not cause this reaction. Source: FDA, December 29, 2008 Milnacipran (Savella) For Fibromyalgia Milnacipran (Savella, Forest/Cypress Bioscience), a selective serotonin and norepinephrine (SNRI) dual-reuptake inhibitor, has been approved to treat fibromyalgia. As many as six million people in the U.S. are affected by widespread pain and impaired physical functioning. Although the drug’s exact mechanism of action is unknown, it is thought that abnormalities in certain brain neurotransmitters might be central to fibromyalgia. Milnacipran blocks the reuptake of both norepinephrine and serotonin. This drug is not approved for patients with major depressive disorder or uncontrolled narrow-angle glaucoma, for children or adolescents, or for patients taking monoamine oxidase inhibitors. Source: Forest/Cypress Bioscience, January 14, 2008 Once-Daily Tramadol (Ryzolt) for Pain Ryzolt extended-release tablets, Labopharm’s once-daily formulation of the analgesic tramadol, have been approved for adults with moderate to moderately severe chronic pain who need aroundthe-clock treatment for an extended period of time. Ryzolt has both immediate-release and extended-release properties. The tablets will be available in strengths of 100 mg, 200 mg and 300 mg. Labopharm’s marketing partner for its product in the U.S. is Purdue Pharma. Source: FDA, Labopharm, December 31, 2008 Plerixafor (Mozobil) Boosts Stem Cells For Transplant Patients Genzyme’s Plerixafor (Mozobil) is an injectable drug that accelerates the gathering blood stem cells for bone marrow transplants. It is designed to be used with granulocyte–colony-stimulating factor (G-CSF) for adults with non-Hodgkin’s lymphoma (NHL) or multiple myeloma. Combined with G-CSF, plerixafor “mobilizes” the number of stem cells released from the bone marrow, thus enabling patients to proceed to transplantation. Almost two million stem cells per kilogram of body weight must be collected, and the process can take three to four hours over several days. For more information about plerixafor, please see the Pharmaceutical Approval Update column on page 86. Sources: FDA, December 18, 2008; www.pharmalive.com Fibrinogen (RiaSTAP) For Rare Genetic Bleeding Disorder The FDA has licensed fibrinogen concentrate (RiaSTAP, CSL Behring), an orphan drug to treat bleeding in patients with congenital fibrinogen deficiency. Patients with this rare genetic defect cannot make sufficient amounts of fibrinogen, which plays an important role in blood coagulation. Fibrinogen is made in the liver and circulates in the plasma. Fibrinogen deficiency is usually diag- Better Sleep with Zolpidem Oral Spray (Zolpimist) Zolpidem tar trate (Zolpimist Oral Spray, NovaDel Pharma), in doses of 5 mg and 10 mg, is now approved for the short-term treatment of insomnia. The company’s NovaMist oral spray technol- Vol. 34 No. 2 • February 2009 • P&T® 67 http://www.fdanews.com http://www.novadel.com http://www.pharmalive.com

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Pharmacy & Therapeutics - February 2009 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Pushing an Expanded Role for Pharmacists Better Asthma Management with Advanced Technology Pharmaceutical Approval Update 58th Annual Meeting, American Society of Human Genetics, 2008 American Society of Hematology, 50th Annual Meeting and Exposition 2008 San Antonio Breast Cancer Symposium Stahl’s Essential Psychopharmacology, 3rd Edition Author Guidelines

Pharmacy & Therapeutics - February 2009

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