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| |  FDA Approves Rhinocort For Once-A-Day Relief Of Allergy Symptoms WAYNE, PA. -- October 4, 1999 -- The U.S. Food and Drug Administration (FDA) has approved its water-based, corticosteroid medication, Rhinocort Aqua™ (budesonide) Nasal Spray, for the treatment of seasonal and perennial allergic rhinitis in adults and children six years of age and older. Rhinocort Aqua provides for once-a-day dosing with a recommended starting dose regimen requiring only one spray per nostril for children and adults. The active medication is budesonide, a corticosteroid, in a fragrance-free aqueous formula that contains no alcohol and no benzalkonium chloride preservative. Rhinocort Aqua uses potassium sorbate as a preservative. In some clinical trials, Rhinocort Aqua provided a significant reduction in the severity of nasal allergy symptoms - congestion, runny nose and sneezing - in as few as 24 hours after initial therapy. Maximum benefit generally takes two weeks to achieve. Product effectiveness depends on use at regular intervals. The recommended once-daily starting dose regimen is one spray per nostril for both adults and children. The maximum recommended dose regimen is two sprays per nostril (children) or four sprays per nostril (adults) administered once-daily. "We are pleased that Rhinocort Aqua will offer allergy sufferers and physicians a new aqueous once-daily, nasal spray that provides a patient-friendly therapeutic option for allergy relief," said Frank Casty, MD, Global Medical Director for Respiratory and Inflammation at AstraZeneca.
Safety and Efficacy of Rhinocort Aqua The safety and efficacy of Rhinocort Aqua was evaluated in seven placebo-controlled clinical trials, which included over 1500 patients aged six years and older with seasonal allergic or perennial allergic rhinitis. The key findings of these trials were that, overall, Rhinocort Aqua significantly reduced the severity of the nasal symptoms - runny nose, sneezing and congestion. The studies demonstrated that Rhinocort Aqua is effective and well-tolerated in both adults and children suffering from seasonal allergic and perennial allergic rhinitis. Rhinocort Aqua showed a low incidence of side effects in clinical trials. The most commonly reported adverse events for Rhinocort Aqua and vehicle placebo (a formulation with no active drug) respectively were: epistaxis (nosebleed) - 8 percent vs 5 percent; pharyngitis (sore throat) - 4 percent vs 3 percent; bronchospasm 2 percent vs 1 percent; nasal irritation - 2 percent vs <1 percent; and coughing - 2 percent vs <1 percent. Patients previously treated with oral corticosteroids (e.g., pills) and transferred to nasal corticosteroids should be carefully monitored for adrenal insufficiency. As with other nasal corticosteroids, after symptomatic relief is achieved, the dose should be reduced to the least amount necessary to control symptoms. Physicians should routinely monitor the growth of children taking intranasal corticosteroids to detect possible growth effects.
Combining Convenience and Efficacy "Convenient dosing is critical with allergy treatments because effective symptom relief is dependent on consistent use of the medication," said Robert Overholt, MD, President of The Allergy, Asthma & Sinus Center in Knoxville, Tennessee. "Given this, patients and physicians should find Rhinocort Aqua to be a useful treatment option combining convenience and efficacy." Rhinocort Aqua is contained in a pocket-sized bottle with each metered dose delivered through a hand-held, wing-tipped applicator. The bottle contains 60 metered sprays. Each spray provides 32 mcg of budesonide mixed in water. Since its introduction in 1986, the intranasal, aqueous formulation of budesonide has been approved for allergic rhinitis relief in over sixty countries, including the United Kingdom and Canada. Budesonide belongs to a class of anti-inflammatory medications known as corticosteroids. Leading U.S. allergy specialists’ organizations - the American Academy of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology and the Joint Council on Allergy, Asthma and Immunology-consider nasally-inhaled corticosteroids to be the most effective medication class for controlling the nasal congestion associated with allergic rhinitis.
Seasonal and Perennial Allergic Rhinitis Takes Its Toll Approximately 20 to 40 million Americans suffer from seasonal and perennial allergic rhinitis. Allergic rhinitis, sometimes known as hay fever, is believed to be the most common chronic allergic disease in the U.S. Although not life-threatening, allergic rhinitis can be serious enough to interfere with daily life - resulting in school absences, lost work days, loss of sleep and a decreased ability to perform everyday activities. Symptoms, such as congestion, sneezing and runny nose, can often be mistaken for the common cold, but unlike a cold can last anywhere from a few weeks to all year. The cost of treating this medical condition and the indirect costs related to lost workplace productivity are significant. In 1995 alone, the estimated costs of allergic rhinitis based on direct and indirect costs were 2.7 billion dollars. Rhinocort Aqua represents a new formulation of the active ingredient, budesonide, which was first launched in the U.S. in 1994 as an aerosolized metered dose inhaler for rhinitis patients six years of age and older. Known as Rhinocort® (budesonide) Nasal Inhaler, it is today the number one prescribed, nasally-inhaled, aerosol-based corticosteroid in the U.S. (Based on IMS Health National Prescription Audit Data, from September 1996 to June 1999). AstraZeneca will continue to market its aerosolized nasal spray - giving patients and physicians a choice of budesonide therapies. Both aerosolized and aqueous formulations provide budesonide in a fragrance-free mixture with a once-a-day dosing schedule.
Related Link: AstraZeneca.
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