IN THE PIPELINE
The following drugs are still in clinical trials:
Alzheimer’s therapy Exelon (rivastigmine tartrate) by Novartis. Company has received an approval letter from FDA for capsule formulation indicated for mild to moderate cases. Notification follows six-month trial of more than 3,000 subjects showing cognition improvement over placebo. Common side effects included nausea, anorexia, dyspepsia, asthenia. Final approval expected by year’s end. Type 2 diabetes treatment Avandia (rosiglitazone maleate by SmithKline Beecham. Recently granted priority status, drug has received approval from FDA’s Endocrinologic and Metabolic Drugs Advisory Committee as monotherapy and in combination with metformin. Of the thiazolidinedione class of drugs, oral therapy is aimed at disrupting insulin resistance. Committee approval follows completion of trials involving more than 5,000 patients resulting in lowering of blood sugar levels by 58 mg/dl in those taking a 4 mg daily dose, and by 76 mg/dl for patients taking 8 mg daily. Trials included six- and 12-month regimens. Common side effects included upper respiratory tract infections and headache. Stroke prevention therapy Aggrenox (dipyridamole 200 mg/aspirin 25 mg) by Boehringer Ingelheim. Also previously granted priority review status, the FDA’s Peripheral & Central Nervous System Drugs Advisory Committee has unanimously recommended approval for twice-daily dosed combination antiplatelet. Drug is indicated for recurrent stroke prevention in patients who have had a transient ischemic attack or ischemic stroke. Approval follows completion of trials of more than 6,000 patients in which risk of stroke was reduced by 37% vs. placebo and by 22% vs. aspirin monotherapy. Common side effects from trials included headache and gastrointestinal disorders. Monotherapy indication for Parkinson’s disease treatment Permax (pergolide mesylate) by Eli Lilly/Elan Pharmaceuticals. Already used as adjunct to levodopa in advanced Parkinson’s treatment, the dopamine agonist has shown tremor, speech, and walking improvement using the Unified Parkinson’s Disease Rating Scale in patients with early stage disease who have been untreated. Clinical trials submitted to American Academy of Neurology of a double-blind, placebo-controlled, randomized study halving 206 patients showed improved outcomes for all measures. Side effects included anorexia, nausea, dizziness, and insomnia. Expanded labeling for rheumatoid arthritis (RA) relief treatment Enbrel (etanercept) by Immunex/Wyeth Ayerst. Approved last November for marketing as a relief treatment for moderate to severely active RA, a supplemental biologics application filed with FDA seeks labeling indication for slowing of structural joint damage in patients with active RA. Similar application has been filed for the injectable drug as a treatment for polyarticular juvenile RA. The applications follow completion of Phase III trials of 633 patients who were active three years or less and were given 10 mg or 25 mg doses for 12 months resulted in positive endpoints via the Modified Sharp Scoring Method. Drug is a biologic response modifer that works by binding tumor necrosis factor to inactivity, which in turn reduces inflammation. Drug is contraindicated in patients with active infections. Expanded indication for Thalomid (thalidomide) by Celgene. Approved last year as treatment for erythema nodosum leprosum caused by leprosy, drug has been granted orphan status by FDA as treatment for intestinal tract inflammatory disorder Crohn’s disease while Phase II trials continue. Drug works by suppressing overproduction of tumor necrosis factor-alpha, but carries strict contraindications and safety procedures based on notoriety for causing birth defects when used as a sleep agent beginning in 1950s. Contraindicated for pregnant or fertile patients. Adverse reactions also include peripheral neuropathy, orthostatic hypotension, neutropenia, and increased HIV viral load.Article Limit Reached
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