Pharmacy & Therapeutics - December 2008 - (Page 688)

NEW DRUGS NEW DRUGS Lacosamide (Vimpat) In Epilepsy Lacosamide (Vimpat, UCB), an antiepileptic drug, has been approved as an add-on agent for partial-onset seizures in patients 17 years of age and older. This approval was based on data from one phase 2 and two phase 3 randomized clinical trials. Fewer than half (47%) of patients attain seizure control with their first medication, and more than 30% continue to experience seizures even with two or more drugs. Lacosamide should be considered for uncontrolled seizures. Dosing should start at 50 mg twice daily and may be increased to a daily dose of 200 to 400 mg/day (the recommended dose) given in two divided doses. Lacosamide will be available as oral tablets and as an intravenous (IV) infusion. It will be designated as a controlled substance. (Source: FDA, October 29, 2008.) DRUG NEWS cytopenic purpura (ITP) who have not responded adequately to corticosteroids, immunoglobulins, or splenectomy. Chronic ITP is marked by increased platelet destruction or inadequate platelet production in the blood. Eltrombopag stimulates the proliferation and differentiation of megakaryocytes, the bone marrow cells that give rise to blood platelets. The company is launching the Promacta Cares program. Prescribers and pharmacies must enroll in the program before they can prescribe or dispense eltrombopag, and patients are required to enroll before they can receive the drug. (Source: GlaxoSmithKline, November 20, 2008.) with urinar y or gastric retention; uncontrolled, narrow-angle glaucoma; or severe liver impairment. (Sources: FDA, November 4, 2008; www.pfizerpro.com.) Rufinamide (Banzel) For Seizures Associated with Lennox–Gastaut Syndrome The FDA has approved rufinamide (Banzel, Eisai) for the adjunctive treatment of seizures associated with Lennox–Gastaut syndrome (LGS) in adults and in children four years of age and older. Children usually experience the onset of LGS between one and five years of age, and from 3% to 7% of these patients die within less than 10 years. Rufinamide is a triazole derivative and is structurally unrelated to other antiepileptic drugs. It is believed to exert its effect by regulating the activity of sodium channels in the brain. The drug’s effectiveness for this indication was established in a multicenter, double-blind, placebo-controlled, randomized study of 138 patients. Antiepileptic drugs can increase the risk of suicidal thoughts or behavior in patients. Rufinamide has been associated with somnolence, coordination abnormalities, dizziness, gait disturbances, and ataxia. As with all antiepileptic agents, rufinamide should be gradually withdrawn to minimize the risk of increased seizure frequency. (Source: Eisai, November 14, 2008, www.eisai.com.) Generic Approvals Generic Sarafem (Fluoxetine) Mylan Pharmaceuticals, Inc., has received final approval from the FDA for Fluoxetine Capsules USP, 10 mg and 20 mg. The capsules, which are indicated for patients with premenstrual dysphoric disorder, are the generic version of Eli Lilly’s Sarafem Pulvules Capsules. (Source: Mylan, November 18, 2008.) Fesoterodine (Toviaz) For Overactive Bladder Fesoterodine fumarate (Toviaz) has been approved to treat overactive bladder. Made by Schwarz Pharma and distributed by Pfizer Inc., the medication relaxes the smooth muscle tissue of the bladder, thus reducing urinar y frequency, the urge to urinate, and sudden urinary incontinence. Toviaz will be available as an extendedrelease, once-daily tablet in either 4-mg or 8-mg dosage strengths. The recommended starting dose is 4 mg. Toviaz is approved only for adults. Toviaz is not recommended in doses above 4 mg in patients with severely reduced kidney function or in patients taking medications such as ketoconazole (Nizoral, Janssen) that block the metabolism of the drug. Toviaz should not be used in patients Generic Pulmicort (Budesonide) For Asthma Teva Pharmaceutical Industries Ltd. has announced the FDA’s approval of its Abbreviated New Dr ug Application (ANDA) to market a generic version of AstraZeneca’s Pulmicort (budesonide) Respules, 0.25 mg/2 mL and 0.5 mg/ 2 mL. Budesonide is indicated for the twice-daily treatment of asthma. Shipment of the product began on November 18, just hours after approval; however, on November 20, a temporary order froze the supply to prevent future sales. Teva is involved in patent litigation concerning this product in the U.S. District Court in New Jersey. A patent trial Eltrombopag (Promacta) For Thrombocytopenia An accelerated approval has been granted for GlaxoSmithKline’s eltrombopag (Promacta), the first oral thrombopoietin receptor agonist for treating thrombocytopenia in patients with chronic immune (idiopathic) thrombo- 688 P&T® • December 2008 • Vol. 33 No. 12 http://www.pfizerpro.com http://www.eisai.com

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Pharmacy & Therapeutics - December 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Interpreting Estimates of Treatment Effects Chemotherapy Foundation Symposium XXVI: Innovative Cancer Therapy for Tomorrow Third Annual Onmark National Payor/Provider Forum Fourth Annual Ophthalmic Drug Development and Delivery Summit Classification and Pharmacological Management Of Obesity CE Test and Forms Season’s Greetings: Thanks to Our Readers and Reviewers

Pharmacy & Therapeutics - December 2008

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