FDA Approves Serevent Diskus for Use in Children With Asthma Ages Four and Up

Innovative Medication Delivery System Can Help Make Asthma Control Easier

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RESEARCH TRIANGLE PARK, N.C., Sept. 28, 1998 -- Just as schoolchildren are settling into the new school year, and fall weather begins, the U.S. Food and Drug Administration (FDA) has approved Serevent(R) Diskus(R) (salmeterol xinafoate inhalation powder) for use in children with asthma as young as four years of age.

Serevent Diskus is now available for the maintenance treatment of asthma in children four years of age and older who have reversible obstructive airway disease, including nocturnal symptoms. Serevent Diskus was also approved for the prevention of exercise-induced bronchospasm in both children and adults. This long-acting, inhaled bronchodilator helps provide long-term, 12-hour control of asthma symptoms and is available in an easy-to-use, breath- activated, dry powder delivery device.

Two out of three children with asthma under 12 years of age have difficulty controlling their symptoms. Asthma can cause children to awaken at night with nocturnal symptoms (e.g., coughing, shortness of breath, chest tightness) and it can cause exercise-induced bronchospasm during physical exertion or exercise. Both conditions may require frequent use of short- acting medicine to control asthma symptoms. When used appropriately, Serevent Diskus, with its 12-hour duration of action and twice daily dosing, helps provide long-term control to help minimize disruption in a child's daily routine.

As many as five million children under the age of 18 have asthma and the prevalence rate for the disease in children is increasing faster than the rate in adults. Asthma is also the number one cause of school absenteeism, accounting for an estimated 10 million missed school days each year. A serious chronic disease that affects nearly 15 million Americans, asthma can be life-threatening if not treated properly.

"Serevent Diskus combines the advantages of a 12-hour control medication with a delivery device that's easy for children to use correctly. This helps parents and children better manage the disease," said Shirley Murphy, M.D., vice president at Glaxo Wellcome Inc., and former chairperson of the National Heart, Lung, and Blood Institute (NHLBI) expert panel, which last year established guidelines for the diagnosis and management of asthma.

Serevent Diskus allows the user or caregiver to monitor drug use through a built-in dose counter, and to determine precisely when a new Diskus is required. The device allows medication to be inhaled with the simple force of the patient's own breath, rather than by the force of a propellant. Each Diskus contains 60 pre-measured dry powder doses in sealed blister packs, which provides for consistent dosing. In addition, a built-in dose counter is a unique Diskus feature.

For maintenance therapy of asthma, patients should take one inhalation of Serevent Diskus twice daily (morning and evening), approximately 12 hours apart. When prescribed for use in preventing exercise-induced bronchospasm (EIB), one inhalation of Serevent Diskus at least 30 minutes before exercise protects patients against EIB for up to 9 hours in adolescent and adult patients, and up to 12 hours in patients aged 4 to 11.

In a large, randomized, double-blind, controlled study (n=449), 50 mcg of salmeterol inhalation powder, via the Serevent Diskus, was administered twice daily to pediatric asthma patients who did and did not receive concurrent inhaled corticosteroids. The efficacy of salmeterol inhalation powder was demonstrated over the 12-week treatment period with respect to periodic serial peak expiratory flow (36-39% post-dose increase from baseline) and FEV1 (32- 33% post-dose increase from baseline). Salmeterol was effective in demographic subgroup analyses (gender and age) and was effective when coadministered with other inhaled asthma medications such as short-acting bronchodilators and inhaled corticosteroids. A second large, randomized, double-blind, placebo- controlled study (n=207) with 50 mcg of salmeterol inhalation powder via an alternate device supported the findings of the trial with Serevent Diskus.

Serevent Diskus is not a substitute for fast-acting bronchodilators, which treat sudden or acute asthma symptoms. Serevent Diskus is a preventive medication that takes longer to be effective. So when sudden symptoms occur, patients still need a fast-acting bronchodilator as prescribed by their doctor. Serevent Diskus is not a substitute for medication that controls inflammation in the lungs. Serevent Diskus can be used with or without anti- inflammatory asthma medication. Patients should not stop or change the dosage of their other asthma medications without talking to their doctor, and if their condition worsens, patients should contact their doctor immediately. Serevent Diskus should not be initiated in patients with significantly worsening or acutely deteriorating asthma, which may be a life-threatening condition.

Asthma is characterized by a reversible obstruction of the bronchial airways of the lungs caused by inflammation and mucus in the airways, and the contraction of the muscles that surround the airways, and airway swelling. The National Heart, Lung, and Blood Institute's (NHLBI) "Guidelines for the Diagnosis and Management of Asthma" recognize the benefits of long-acting beta2-agonists (like Serevent Diskus) for long-term treatment of asthma and prevention of symptoms in patients with moderate and severe persistent asthma.

Serevent is the most prescribed brand of long-acting maintenance asthma medication, with over 3.5 million patients treated since 1994. In clinical trials of Serevent Diskus with children ages 4 to 11, the most commonly reported adverse events (>5%) were headache (17%) and sore throat (6%).

Serevent Diskus was developed and is marketed by Glaxo Wellcome Inc., an industry leader in respiratory research. The company has a broad portfolio of commercially available respiratory therapies.

CONTACT: For full prescribing information, please contact Lisa Behrens at Glaxo Wellcome Inc., 919-483-2839.