Pharmacy & Therapeutics - March 2009 - (Page 124) NEW DRUGS NEW DRUGS Dexlansoprazole (Kapidex) For Esophageal Disease The FDA has approved dexlansoprazole delayed-released capsules (Kapidex, Takeda Pharmaceuticals) to treat heartburn associated with symptomatic nonerosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis, and the maintenance of healed erosive esophagitis. Acid reflux disease can be characterized by frequent, persistent heartburn that occurs two or more days a week despite treatment and dietary changes. Proton pump inhibitors (PPIs) help to reduce acid production by turning off many of the acid pumps in the stomach. Dexlansoprazole combines an enantiomer of a form of Takeda’s lansoprazole (Prevacid) and protects the esophagus from acid reflux so that esophageal inflammation can heal. In doses of 30 mg and 60 mg, dexlansoprazole provides two releases of medication. Two types of enteric-coated granules result in a profile with two distinct peaks: one to two hours after administration, followed by a second peak within four to five hours. This medication can be taken without regard to meals. In phase 3 clinical studies, dexlansoprazole provided up to 24-hour heartburn relief with a side-effect profile similar to that of the company’s lansoprazole (Prevacid). Dexlansoprazole should not be taken with atazanavir (Reyataz, Bristol-Myers Squibb). It can interfere with the absorption of drugs for which gastric pH is important for bioavailability, such as ampicillin esters, digoxin, iron salts, and ketoconazole (Nizoral, PriCara). Patients taking dexlansoprazole along with warfarin (Coumadin, Bristol-Myers Squibb) may need to be monitored for increases in the International Normalized Ratio and prothrombin time. DRUG NEWS from the milk of goats that have been genetically engineered by introduction of a segment of recombinant DNA (rDNA) into the genes with instructions for the goat to produce human antithrombin in its milk. Antithrombin is a protein that occurs naturally in healthy individuals and prevents blood from clotting. Hereditary antithrombin deficiency is usually first recognized in teenagers or young adults when clots develop in blood vessels, particularly during pregnancy, surgery, or prolonged bed rest. Over seven generations, the introduction of rDNA did not cause adverse outcomes to the health of the goats. Procedures were also in place to ensure that food from the goats did not enter the food supply. As part of the approval, the goats cannot be used for food or feed. ATryn will initially be limited to about 100,000 patients. Previously approved in Europe for preventing clotting during surgery, ATryn will be marketed by Ovation Pharmaceuticals. Sources: FDA, February 6, 2009, www. fda.gov/cvm/geanimals.htm; The Wall Street Journal, February 7–8, 2009 Source: Takeda, Januar y 30, 2009, www.kapidex.com. Generic Tindamax (Tinidazole) For Sexually Transmitted Diseases BioComp Pharma, Inc., has launched Tinidazole 500, the first generic version of Tindamax, an oral antimicrobial second-generation compound. This drug is approved for treating trichomoniasis and bacterial vaginosis as well as giardiasis, intestinal amebiasis, and amebic liver abscess. Almost 7.4 million new cases of trichomoniasis occur in men and women each year. Trichomoniasis is the most common curable sexually transmitted disease among young women in the U.S., and bacterial vaginosis is the most common vaginal infection in women of childbearing age. Tinidazole 500 allows for targeted dosing and a shorter course of therapy. It is administered as 1 gram (two 500-mg tablets, once daily for five days) or 2 grams (four 500-mg tablets, once daily for two days) to treat bacterial vaginosis and as 2 grams (four 500-mg tablets for one day) to treat trichomoniasis infection. Source: BioPharma, February 3, 2009 Febuxostat (Uloric) for Gout The FDA has approved febuxostat (Uloric, Takeda), the first new gout drug in more than 40 years. Taken once daily by mouth, this agent is approved for the chronic management of hyperuricemia in patients with gout. The drug blocks an enzyme called xanthine oxidase, which helps prevent uric acid production. The tablets are sold in strengths of 40 and 80 mg. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia. In 2005, the FDA refused to approve febuxostat because slightly more deaths and heart problems occurred in patients taking the drug than in patients taking allopurinol, another gout drug. Because ATryn from Goats Benefits Rare Clotting Disorder A biological product originating from genetically engineered animals has been approved. ATryn, an anticoagulant made by GTC Biotherapeutics, is indicated for preventing blood clots in patients with hereditar y antithrombin deficiency. These patients are at high risk of blood clots during surgery and before, during, and after childbirth. Because this deficiency occurs in only 1 in 2,000 to 5,000 people in the U.S., an orphan drug designation was granted. ATryn is a therapeutic protein derived 124 P&T® • March 2009 • Vol. 34 No. 3 http://www.kapidex.com http://www.fda.gov/cvm/geanimals.htm http://www.fda.gov/cvm/geanimals.htm
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