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FDA Approves AccuNeb (Albuterol Sulfate) For Treatment of Pediatric Asthma

NAPA, CA -- May 2, 2001 -- Dey, L.P., an Associate of Merck KGaA, Darmstadt, Germany, announced today the FDA approval of AccuNeb™ (albuterol sulfate) Inhalation Solution 1.25 mg*/3mL and 0.63 mg*/3mL (*potency expressed albuterol, equivalent to 1.5 mg and 0.75 mg albuterol sulfate). It is the first premixed, premeasured, reduced-dosages of albuterol inhalation solution for the relief of bronchospasm in patients two to 12 years of age with asthma.

"Because AccuNeb is premixed and premeasured, its availability is a real service to the families of children with asthma," said Charles Rice, CEO of Dey. "We're very proud to introduce these sterile and preservative-free inhalation solutions designed and clinically tested for pediatric asthma patients."

Parents or pharmacists previously used a higher concentration or were required to dilute a higher dosage of albuterol for their pediatric patients. AccuNeb provides the first pediatric-specific albuterol preparation to the U.S. market. AccuNeb contains no benzalkonium chloride (BAC).

Available in sterile and preservative-free unit-dose vials, AccuNeb complies with National Asthma Education and Prevention Program guidelines for pediatric asthma patients and is available in two concentrations: 1.25 mg and 0.63 mg (potency expressed as albuterol, equivalent to 1.5 mg and 0.75 mg albuterol sulfate). These two concentrations of AccuNeb reduce the likelihood of mixing errors and cross-contamination from dilution of higher strength albuterol.

According to the Centers for Disease Control, asthma affects 17 million Americans, including almost five million children. Asthma is a reversible chronic inflammatory disorder of the airways that can result in recurrent episodes of wheezing, breathlessness, chest tightness, and coughing.

The FDA approval was based in part on data from a clinical trial involving 349 pediatric asthma patients. Both the 1.25 mg and 0.63 mg strengths of AccuNeb produced significant improvement in forced expiratory volume (FEV1) compared to placebo.

In a clinical trial with AccuNeb and placebo, the adverse events most commonly reported were: asthma exacerbations (13 percent, 11.1 percent, 8.5 percent); otitis media (4.3 percent, 0.9 percent, 0 percent); allergic reaction (0.9 percent, 3.4 percent, 1.7 percent); gastroenteritis (0.9 percent, 3.4 percent, 0.9 percent); and flu syndrome (2.6 percent, 2.6 percent, 1.7 percent).

Like other inhaled beta-adrenergic agonists, AccuNeb can produce paradoxical bronchospasm, which may be life-threatening. AccuNeb should be used with caution in patients with cardiovascular disorders (specifically, coronary insufficiency, cardiac
arrhythmias, and hypertension) and patients being treated with epinephrine, oral sympathomimetics, beta-blockers, monoamine oxidase inhibitors, or tricyclic antidepressants.

SOURCE: Dey, L.P.

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