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8/14/2000

FDA Approves New Therapies for Seniors

Cheryl A. Thompson

Over a recent four-week period, the Food and Drug Administration (FDA) approved four treatments for conditions affecting primarily seniors, and an advisory panel recommended a device for broader symptomatic relief of Parkinson’s disease.

In early April, FDA approved a request to expand the labeling for Activella tablets, containing estradiol and norethindrone acetate, to include the prevention of postmenopausal osteoporosis in women with an intact uterus. The product, by Novo Nordisk Pharmaceuticals, already had approval for treating moderate to severe symptoms of menopause and vulvar and vaginal atrophy.

Verteporfin is the first effective drug available for the treatment of age-related macular degeneration. This agent exerts its effect after activation by a laser light shined directly into the patient’s eye. Verteporfin is sold as Visudyne, by Ciba Vision.

Options for the prevention and treatment of osteoporosis widened with the approval of risedronate sodium, which is useful against postmenopausal and corticosteroid-induced forms of the disease. This bisphosphonate agent, known by the brand name Actonel, will be marketed by Alliance for Better Bone Health, a partnership between Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals.

For people with mild to moderate Alzheimer’s disease, there is now rivastigmine tartrate, a reversible cholinesterase inhibitor. Unfortunately, the drug is associated with a high incidence of nausea and vomiting. Packages of Exelon oral solution, by Novartis Pharmaceuticals Corp., will include an instruction sheet describing how caregivers should administer the product; caregivers with questions will be directed to ask their pharmacist or physician.

In an action not as widely known as the drug approvals, FDA’s Neurological Devices Panel conditionally approved a request to expand the use of Activa Deep Brain Stimulator Parkinson’s Control System, by Medtronic Inc. The request centers on use of a neurostimulator implant to deliver bilateral deep-brain stimulation to treat symptoms of advanced Parkinson’s disease. The advisory committee noted deficiencies in the company’s study but acknowledged the device’s "great promise."