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2/2/2004

Spiriva Earns FDA Approval

Kate Traynor

The Food and Drug Administration on Friday approved the marketing of the Spiriva HandiHaler, a long-acting tiotropium bromide inhalation powder for the maintenance treatment of bronchospasm in patients with chronic obstructive pulmonary disease (COPD).

Tiotropium blocks certain muscarinic receptors in the lung, preventing acetylcholine from binding to the receptors and triggering bronchoconstriction. The product was developed by Boehringer Ingelheim and is to be comarketed in the United States by Boehringer and Pfizer Inc. Boehringer expects the product to be available in this country by summer.

In clinical trials, the company said, the most frequent adverse event reported by tiotropium users was dry mouth, usually mild, which often resolved during treatment. Infrequent adverse events included constipation and increased heart rate.

Cautious use of the drug is advised in patients with glaucoma or prostatic hyperplasia, conditions whose symptoms may worsen during tiotropium therapy.

Tiotropium earned regulatory clearance in Canada earlier this month. According to Pfizer, the product is currently marketed in more than 40 countries.