Drug Topics - June 2, 2008 - (Page 6) 6 DRUG TOPICS JUNE 2, 2008 www.drugtopics.com > > >NEWS Roundup Rx Care Abilify gets go-ahead as add-on therapy A new indication for aripiprazole (Abilify, Bristol-Myers Squibb/Otsuka) has been approved by the Food & Drug Administration. The drug can now be used as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in adults. The regulatory nod came after review of a study of 384 patients who received stabilized doses of lithium or valproate to achieve therapeutic blood levels. Patients who demonstrated an inadequate response were then randomized to receive either aripiprazole (15 mg or 30 mg) or placebo. Addon aripiprazole demonstrated statistically significant improvement in symptoms when compared with the adjunctive placebo (p=0.002). The FDA also approved changes to the aripiprazole label to include new pharmacokinetic information on the co-administration of 10 mg/day to 30 mg/day with 100 mg/day lamotrigine. A “no dosage adjustment of lamotrigine is required when aripiprazole is added to lamotrigine” statement was also added. Aripiprazole was previously approved in 2004 as a monotherapy for the treatment of manic or mixed episodes associated with bipolar I disorder in adults. Government and Law CMS proposes more marketing rules for Part D and Medicare Advantage plans Last week, the Centers for Medicare & Medicaid Services proposed new marketing rules designed to protect beneficiaries in Medicare Advantage and Part D drug plans from being hurt by unscrupulous sales agents. Among the proposed rules is the banning of cold calling of patients and sales activities at educational events, such as health fairs, or in areas such as waiting rooms. CMS wants to receive your comments by July 15. Oklahoma pharmacies can now renew their narcotic registration online Pharmacies in Oklahoma can renew their narcotic registration online through www.ok.gov. So announced the Oklahoma State Bureau of Narcotics and Dangerous Drug Control (OBNDD), which launched the service. OBNDD said registrants can pay securely online with Visa, MasterCard, or an electronic check. Upon completing the renewal process, registrants can print their certificates, thus reducing mailing and printing costs for OBNDD. The agency estimates that this new system will eliminate paper, increase efficiency, and save $3,500 in the first year. Pennsylvania passes law letting unused cancer drugs to be returned Under a bill just signed into law by Governor Edward G. Rendell, entities that are part of a closed drug delivery system can return certain cancer drugs to approved pharmacies for redispensing to indigent patients. The cancer drugs that are returned must still be in their original packaging and have an expiration date no sooner than six months after the date the cancer drug was restocked. Senate Bill 638 also allows drugs dispensed under a state medical assistance program to be accepted and dispensed. No compensation will be allowed for returned drugs. However, participating pharmacies may charge a handling fee under the program. This voluntary cancer drug repository program will be carried out under the supervision of the state board of pharmacy. The law takes effect in 60 days and the board will develop regulations within 90 days of the effective date of the law. New Factor VIIa product now OK at room temperature NovoSeven RT, from Novo Nordisk, recently received Food & Drug Administration approval. The new formulation of NovoSeven Coagulation Factor VIIa (recombinant) contains both sucrose and l-methionine, which allow the new product to be stored at room temperature. Specifically, NovoSeven RT can be stored at up to 81 degrees Fahrenheit for as long as two years. According to the manufacturer, the change will be helpful for medical facilities with limited refrigerator space. The new product will share the same indications as its predecessor—the treatment of bleeding and prevention of surgical bleeding in patients with hemophilia A or B who have neutralizing antibodies against Factors VIII or IX or have congenital Factor VII deficiency, and the prevention of surgical bleeding in patients with acquired hemophilia. The original formula required storage between 36 and 46 degrees Fahrenheit. 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