Your Yourlocation: Home > FDA experts support tiotropium bromide(136310-93-5) for obstructive pulmonary disease but not for dyspnea

The FDA's Pulmonary Allergic Drug Advisory Committee has recommended the approval of BoehringerIngelheim (BI)'s muscarinic M3 antagonist tiotropium bromide(136310-93-5) (tirrtium bromide, Spiriva) once a day long-term maintenance for the treatment, including chronic bronchitis and lung Emphysema of chronic obstructive pulmonary disease (COPD) associated with bronchospasm.

All members unanimously rejected COPD as one of the more difficult to control the symptoms of dyspnea as a specific treatment indication for the drug. Mr. Loss, a Washington-based industrial analyst, said the panel's rejection of the indication for dyspnea would disappoint BI and its partner Pfizer, particularly its first market in the Netherlands and the subsequent European Community market, improved dyspnea data to adverse indications.

However, tiotropium bromide(136310-93-5) is expected to become a potent competitor in the treatment of COPD, even if there is no indication of dyspnea, which may replace the older bronchodilator iprat-ropium bromide (Atrovent). The latter is suitable for COPD-related maintenance treatment of bronchial spasm. Tiotropium bromide(136310-93-5) may soon be facing competition from GlaxoSmithKline's asthma-inhalant flu-ticasonepropionate (FloventDiskus), fluticasone propionate /salmeterol (AdvairDiskus), in January they were recommended other indications for COPD.

Tiotropium was superior to ipratropium bromide in all the clinical observations, and tiotropium was significantly superior to placebo in all clinical observations in the United States of one-second forced expiratory volume (FEV1) test and all clinical observations.

"The incidence of serious adverse events in the tiotropium group was higher than in the placebo group, including heart rate and arrhythmia," said Dr. Sullivan, FDA's medical officer. The incidence of serious adverse events was 1.3% in the tiotropium group and 0.5% in the placebo group, with the same mortality rates in both groups.

More than 70 cases of constipation in elderly patients, the use of tiotropium bromide(136310-93-5) for 6%, 1.7% with placebo (a tiotropium in patients with fecal impaction and hospitalization). Dry mouth is also more common (16% for tiotropium and 2.7% for placebo).

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