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| |  FDA Approves Once-A-Day Dosing Of Pulmicort Tubuhaler For Asthma WESTBOROUGH, MA -- Oct. 15, 1998 -- The United States Food and Drug Administration has approved a once-a-day treatment option for Astra Pharmaceuticals, L.P.’s Pulmicort Turbuhaler® 200 mcg (budesonide inhalation powder) for adults and children as young as six with mild to moderate asthma well-controlled by an inhaled corticosteroid. This approval comes only eight months after the availability of Pulmicort Turbuhaler for use twice daily in adults and children in the U.S. The approval follows a U.S. study and other supportive studies submitted to the FDA that demonstrated the safety and effectiveness of Pulmicort Turbuhaler when taken once daily by asthmatics with mild to moderate disease adequately controlled by inhaled corticosteroid medication. Until now, the recommended dosing for the entire class of inhaled corticosteroids has been from two to four times a day. Pulmicort Turbuhaler treats airway inflammation, the underlying cause of asthma and is indicated for the maintenance treatment of asthma as prophylactic therapy for adults and children six years and older. In addition, Pulmicort Turbuhaler is indicated for patients requiring oral corticosteroid therapy for asthma -- the recommended dose for these patients is twice daily. Improvement following inhalation occurs within 24 hours of beginning treatment, although maximum benefit may not be achieved for one to two weeks or longer. Pulmicort Turbuhaler is not a bronchodilator and is not intended to treat acute or life-threatening asthma attacks. The medication has been used for long-term control of asthma in children and adults for over 15 years in more than 65 countries. The adverse events profile of once-daily administration of Pulmicort Turbuhaler was evaluated. Findings indicated that the frequency and pattern of adverse events was similar when compared to previous studies where Pulmicort Turbuhaler was administered twice daily. Incidence of adverse events in past trials with Pulmicort Turbuhaler at 200 mcg given twice a day -- and compared to placebo -- have been as follows: respiratory infection -- 20 percent and 17 percent; headache -- 14 percent and seven percent; oral candidiasis – two percent and two percent; voice alteration (hoarseness) -- one percent and zero percent; sore throat -- 10 percent and nine percent; and sinusitis -- 11 percent and seven percent, respectively. Inhaled corticosteroids, like Pulmicort Turbuhaler, have long been recognised by doctors as safe and effective anti-inflammatory medications for asthma. As with any medication, however, the benefits and risks should be understood. Patients on inhaled corticosteroids should be monitored for any potential side effects and the dose reduced to the lowest amount necessary to maintain effective control. If patients are switched to these medications from systemic steroids (tablets), they need to be carefully monitored by their doctors to avoid health risks associated with stopping the use of systemic steroids The medication, marketed under the name of Pulmicort, is delivered simply through a multi-dose, inhalation-driven inhaler known as Turbuhaler. When the patient closes his or her lips around the mouthpiece of Pulmicort Turbuhaler and breathes in, air drawn through the device delivers the fine, dry powdered medication into the lungs. No co-ordination is required between activating the device and inhaling, as with many other asthma inhalers. Additionally, Pulmicort Turbuhaler contains 200 doses, a dose indicator (showing when it is empty) and no taste or smell upon delivery of the medication. The U.S. National Institutes of Health (NIH) emphasise the importance of treating airway inflammation -- which underlies asthma -- with inhaled corticosteroids. NIH considers these medications to be the most effective anti-inflammatory therapy today for the control of asthma. Inhaled corticosteroids are the most widely prescribed therapy for long-term control of asthma. Pulmicort Turbuhaler once-daily dosing was studied in an 18-week U.S. trial involving over 300 adult asthmatics who received either the medication (400 mcg or 200 mcg) once a day or placebo. The study showed that patients with mild to moderate asthma previously controlled on inhaled corticosteroids treated with Pulmicort Turbuhaler once-daily maintained their lung function compared to patients on placebo whose lung function worsened. Compared with placebo, patients receiving Pulmicort Turbuhaler 200 mcg or 400 mcg once daily showed significantly better asthma stability. The Turbuhaler, delivers the medication without the use of propellant gases such as chlorofluorocarbons (CFCs). Pulmicort Turbuhaler was the first FDA-approved, CFC-free corticosteroid in the U.S. A multi-national ban has been placed on the production of CFCs, which are being phased out of asthma inhalers. Related Links: Astra Pharmaceuticals, Pulmicort Turbuhaler
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