FDA approves Sepracor's Xopenex HFA Metered-dose Inhaler
MARLBOROUGH, MASS., March 11, 2005 -- Sepracor Inc. announced that the FDA has approved its New Drug Application (NDA) for Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, a hydrofluoroalkane (HFA) metered- dose inhaler (MDI) for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease. Reversible obstructive airway disease includes respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD).
The MDI development program included approximately 1,870 pediatric and adult subjects and 54 studies (preclinical and clinical). In 2003, Sepracor completed its Phase III studies of Xopenex HFA. In each of the three, large- scale, pivotal Phase III trials that Sepracor conducted, the Xopenex HFA MDI was well tolerated and met the targeted efficacy endpoints in both adults and children with asthma. In the primary airway function measure, FEV1 (a test of lung function that measures the amount of air forcefully exhaled in one second), the Xopenex HFA MDI produced statistically and clinically significant improvements relative to placebo.
Sepracor's Xopenex MDI utilizes state-of-the-art HFA technology and does not contain a chlorofluorocarbon (CFC) propellant. MDIs are portable, hand- held devices consisting of a pressurized canister containing medication and a mouthpiece through which the medicine is inhaled. Each canister provides 200 actuations (or inhalations). Sepracor and 3M Drug Delivery Systems Division are collaborating under an agreement that includes scale-up, manufacturing and supply of the Xopenex HFA. The collaboration combines Sepracor's short-acting beta-agonist, Xopenex, and 3M's expertise in manufacturing MDIs, the device most commonly used by patients for the treatment of asthma and COPD.
Sepracor currently markets Xopenex Inhalation Solution through the company's 1,250-person sales force. Xopenex Inhalation Solution is a short- acting bronchodilator indicated for the treatment or prevention of bronchospasm in patients 6 years of age and older with reversible obstructive airway disease. Xopenex Inhalation Solution is available for use in a nebulizer at 0.31 mg and 0.63 mg dosage strengths for treatment of children 6 to 11 years old, and in 0.63 mg and 1.25 mg dosage strengths for patients 12 years of age and older. Xopenex Inhalation Solution revenues for the twelve months ended December 31, 2004 were approximately $319.8 million.
Approximately 90 percent of the short-acting beta-agonist inhalers sold in 2004 contained CFC propellants, according to IMS Health information. Under provisions in the Montreal Protocol on Substances that Deplete the Ozone Layer, an international agreement that requires the phase-out of substances that deplete the ozone layer, MDIs containing CFC propellants would be subject to eventual removal from the marketplace. In June 2004, the FDA issued a proposed rule for the removal of the essential use exemption for albuterol, which currently permits the use of CFC-containing albuterol inhalers despite environmental concerns. Removal of this essential use exemption would prevent albuterol products containing CFC propellants, including MDIs, from being marketed in the U.S.
Safety Information
Xopenex HFA is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol or any other component of Xopenex HFA. Xopenex HFA and other beta-agonists can produce paradoxical bronchospasm, which may be life threatening. If additional adrenergic drugs, including other short-acting sympathomimetic aerosol bronchodilators or epinephrine, are to be administered with Xopenex HFA by any route, they should be used with caution to avoid deleterious cardiovascular effects. Due to the cardiovascular side effects associated with beta-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias and hypertension), diabetes, hyperthyroidism, or convulsive disorders. Also, see the complete prescribing information regarding potential drug interactions with beta-blockers, diuretics, digoxin, or MAOI and tricyclic antidepressants.
Source: Sepracor www.sepracor.com
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