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Pharmacy Drugs

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FDA Okays New Indication for COPD Inhaler

Posted by: admin in Pharmacy Drugs on March 28th, 2010

WASHINGTON — The FDA has expanded the approved indications for inhaled tiotropium bromide (Spiriva HandiHaler) to include reducing exacerbations of chronic obstructive pulmonary disease (COPD), in addition to its previous approval for COPD maintenance.

Tiotropium is a bronchodilator that works by antagonizing acetylcholine receptors in airway tissues.

The new indication was based on results of two clinical trials with nearly 8,000 patients combined — one called UPLIFT and a separate six-month study with patients in a Veterans Affairs setting.

Although the drug failed to meet its primary endpoint in UPLIFT, significantly slowing declines in lung function versus placebo, it did show benefits in reducing exacerbations. These were defined as new onset or increase of symptoms over at least three days and required a change in treatment or hospitalization. (See Tiotropium Has Benefits in COPD)

Participants in the UPLIFT trial were permitted to use all nonanticholinergic respiratory medications and were assigned to either tiotropium or placebo. The tiotropium group saw a median 16.7-month delay before the first exacerbation of symptoms (95% CI 14.9 to 17.9).

The drug was also associated with a mean 14% reduction in number of exacerbations (P<0.001), though there was no significant difference between groups in exacerbations leading to hospitalization.

In addition to the new indication, the drug’s label now includes some of the UPLIFT study data.

In a press release, the two companies that co-market the product, Pfizer and Boehringer Ingelheim, said it was the first steroid-free drug approved for COPD maintenance that is also demonstrated to reduce exacerbations.

As before, the drug includes several cautions including:

Tiotropium bromide is contraindicated in patients with an allergy to atropine or its derivatives.
Patients with an allergy to tiotropium or a past allergy to ipratropium should not take the drug.
The inhaler is not intended as a rescue therapy and is not indicated for use in treating sudden breathing problems.
The drug may worsen symptoms in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.
Patients who experience any hypersensitivity symptoms, such as lip, tongue, or throat swelling or paradoxical bronchospasm, should discontinue inhaler use immediately.

Common side effects include upper respiratory tract infection, dry mouth, sinus infection, and sore throat.