Magazine article Drug Topics

Glaxo Beta(2)-Agonist Recommended for Approval by FDA

Magazine article Drug Topics

Glaxo Beta(2)-Agonist Recommended for Approval by FDA

Article excerpt

The Food & Drug Administration's Pulmonary-Allergy Drugs Advisory Committee has recommended the approval of Glaxo Inc.'s Serevent (salmeterol). If it gets the official go-ahead soon, the agent will be the first long-acting, inhaled beta sub 2 -agonist to reach the U.S. market.

FDA's panel "unanimously recommended" that Serevent be approved for long-term, twice-daily use in the treatment and prevention of bronchospasm in patients 12 years and older with reversible obstructive airway disease, or asthma, Nancy Pekarek, Glaxo's manager of media relations told Drug Topics. The drug was also recommended for prevention of exercise-induced bronchospasm in patients 12 years of age and older.

Serevent, which opens up constricted airways, is "specially designed for taking two puffs in the morning and two puffs in the evening," allowing a 12-hour duration of action, Pekarek said. "That allows you to sleep through the night." she added. "If you're an asthma sufferer, that's a big problem."

Plus, studies indicate that patients should be able to reduce the incidence of "breakthrough" asthma attacks when they use the long-acting medication as directed, Pekarek continued. Serevent, she said, seems to provide "better overall control of the asthma symptoms. …

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