Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved ArmonAir RespiClick (fluticasone propionate inhalation powder) for adolescent and adult patients with asthma. The medication is delivered via Teva’s RespiClick® breath-activated, multi-dose dry powder inhaler (MDPI) which is used with other approved medicines in Teva’s respiratory product portfolio.
ArmonAir RespiClick is an inhaled corticosteroid (ICS) containing the same active ingredient as Flovent, and is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.
ArmonAir RespiClick is expected to become available to patients in the U.S., by prescription, later this year. The approved strengths of ArmonAir RespiClick are: 55 mcg, 113 mcg, and 232 mcg administered as one inhalation twice daily.
The FDA approval of ArmonAir RespiClick is supported by data from Teva’s clinical development program, including three Phase III trials which evaluated the efficacy and safety of the treatment in adolescent and adult patients with asthma. In the two double-blind studies, the therapy showed clinically relevant and greater benefit compared with placebo in the improvement of lung function after 12 weeks of treatment as measured by Forced Expiratory Volume in one second (FEV1). In ArmonAir RespiClick clinical trials, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and upper respiratory tract infection.
About ArmonAir RespiClick (Fluticasone Propionate) Inhalation Powder
ArmonAir RespiClick is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
Important Limitation of Use: ArmonAir RespiClick is NOT indicated for the relief of acute bronchospasm.
IMPORTANT SAFETY INFORMATION
- Contraindications: ArmonAir RespiClick is contraindicated in:
- the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
- patients with known severe hypersensitivity to milk proteins or known hypersensitivity to fluticasone propionate or any of the excipients
- Local Effects: Oropharyngeal candidiasis has occurred in patients treated with ArmonAir RespiClick. Advise patients to rinse the mouth with water without swallowing following inhalation
- Acute Asthma Episodes: ArmonAir RespiClick is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir RespiClick, should be used to relieve acute symptoms such as shortness of breath
- Immunosuppression: Patients on corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution, if at all, in patients with the above because of the potential for worsening of these infections
- Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Slowly taper the dose of systemic corticosteroids if transferring patients to ArmonAir RespiClick
- Hypercorticism and Adrenal Suppression: Because of the possibility of significant systemic absorption of inhaled corticosteroids, patients on ArmonAir RespiClick should be observed carefully for any evidence of systemic corticosteroid effects. If such effects occur, the dosage of ArmonAir RespiClick should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and for management of asthma symptoms
- Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may...
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