Combo Cholesterol Drug Gets FDA Approval

Vytorin (ezetimibe/simvastatin) by Merck/Schering-Plough Pharmaceuticals in July was approved by the U.S. Food and Drug Administration for the treatment of high LDL cholesterol (LDL-C) in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

Vytorin, a combination of two cholesterol drugs, is the first product approved to treat the two sources of cholesterol, according to a press release from the companies. Vytorin inhibits the production of cholesterol in the liver and blocks the absorption of cholesterol in the intestine, including cholesterol from food.

The recommended starting dose of Vytorin is 10 mg ezetimibe and 20 mg simvastatin. Vytorin is also available in doses of 10 mg/10 mg, 10 mg/40 mg and 10 mg/80 mg.

Muscle pain, tenderness or weakness in people taking Vytorin should be reported immediately because these symptoms can be signs of a serious side effect. Vytorin should be discontinued if myopathy is suspected. Clinicians should perform blood tests before beginning treatment with Vytorin and during treatment to check for liver problems. Patients taking the 10 mg/80 mg dose should receive additional liver function tests during treatment.

The most commonly reported side effects reported in clinical trials of Vytorin included headache, upper respiratory tract infection, myalgia, influenza and extremity pain.

Fibrillation Drug Available in Extended-Release Capsules

Rythmol SR (propafenone extended release) by Reliant Pharmaceuticals is a recommended first-line therapy for atrial fibrillation (AF) by the American College of Cardiology, the American Heart Association and the European Society of Cardiology guidelines for the treatment of AF patients with no or minimal structural heart diseases, as well as for patients with AF and hypertension with left ventricular hypertrophy less than 1.4 cm, according to a company press release.

Results of the Rythmol SR Atrial Fibrillation Trial (RAFT) of more than 500 patients demonstrated that 70% of patients treated with the most effective dose of Rythmol SR remained free of symptoms for the duration of the 39-week study, and no pro-arrhythmias (including torsades de pointes) or deaths were reported.

Reliant Pharmaceuticals acquired the Rythmol product family from Abbott Laboratories in 2003. Rythmol SR is available 225 mg, 325 mg and 425 mg capsules. The most common adverse events reported in trials of Rythmol and Rythmol SR include taste disturbances, dizziness, dyspnea and nausea.

Botox Approved for Severe Underarm Sweating

The U.S. Food and Drug Administration in July approved Botox (botulinum toxin type A) by Allergan for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents, according to a company news release. Primary axillary hyperhidrosis often goes undiagnosed and untreated due to lack of awareness by patients and clinicians, according to the release.

The FDA based the approval on the results of two phase III clinical studies. In a pivotal study of 322 patients conducted in the United States, Botox was significantly superior to placebo in improving hyperhidrosis severity.

Botox has been approved for four therapeutic indications over the last 15 years. It is also indicated for cervical dystonia, blepharospasm and strabismus.

Prevacid Receives 2 New FDA Approvals

Prevacid (lansoprazole) by Tap Pharmaceutical Products recently received two approvals from the U.S. Food and Drug Administration. The FDA approved Prevacid in June for the short-term treatment of symptomatic gastroesophageal reflux disease and erosive esophagitis in children aged 12 to 17 years. The FDA in July also approved Prevacid SoluTab Delayed-Release Orally Disintegrating Tables.

Prevacid SoluTab is the only orally disintegrating formulation of a proton-pump inhibitor approved in the United States. The tablets can be taken with or without water and are strawberry flavored. For administration with an oral syringe or nasogastric tube, the tablets can be dissolved in water.

Cream Approved for Basal Cell Carcinoma

Aldara (imiquimod) Cream, 5% by 3M Pharmaceuticals in July received approval from the U.S. Food and Drug Administration for the treatment of superficial basal cell carcinoma (sBCC), a type of nonmelanoma skin cancer. Aldara Cream is the first treatment for sBCC approved in almost 10 years, according to a company press release.

In two phase III clinical studies of 364 patients with sBCC, 82% of patients treated with Aldara Cream achieved histologic clearance, and 75% achieved composite clearance, according to the release.

The FDA also recently approved Aldara Cream for the treatment of certain types of actinic keratosis on the face or scalp in adults with normal immune systems.