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XOPENEX HFA™ Metered-Dose Inhaler NDA Filed by FDA
MARLBOROUGH, Mass., July 15 /PRNewswire-FirstCall/ -- Sepracor Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for formal review Sepracor's New Drug Application (NDA) for XOPENEX HFA™ (levalbuterol tartrate HFA) Inhalation Aerosol, a hydrofluoroalkane (HFA) metered-dose inhaler (MDI). The FDA also notified Sepracor that the Prescription Drug User Fee Act (PDUFA) date for XOPENEX HFA MDI is March 12, 2005. A PDUFA date is the date by which the FDA is expected to review and act on an NDA submission.
On May 12, 2004, Sepracor submitted an NDA for XOPENEX HFA MDI for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease, such as asthma and chronic obstructive pulmonary disease (COPD).
Sepracor's 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 (p
Approximately 95 percent of the short-acting beta-agonist inhalers sold in 2003 contained chlorofluorocarbon (CFC) propellants, according to IMS Health information. In June 2004, the FDA issued a proposed rule for the removal of the essential use exemption, which currently permits the use of CFC-containing albuterol inhalers despite environmental concerns. Removal of the essential use exemption would prevent albuterol products containing CFC propellants, including MDIs, from being marketed in the U.S. The XOPENEX MDI uses HFA technology and does not contain a CFC propellant.
Asthma is a chronic lung disorder characterized by reversible airway obstruction and the pathologic finding of airway inflammation. According to the American Lung Association, approximately 26 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects approximately 8.6 million children in the U.S. under the age of 18. Short-acting beta-agonists are the most-prescribed asthma therapy among primary care physicians and pediatricians in the U.S., according to IMS Health information.
The U.S. short-acting bronchodilator MDI market potential at branded prices, assuming parity pricing to branded PROVENTIL® HFA, is approximately $1.6 billion.
Sepracor currently markets XOPENEX® brand levalbuterol HCl inhalation solution for use with a nebulizer through its primary care and hospital sales force. XOPENEX inhalation solution is FDA approved 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.
Sepracor expects that the XOPENEX HFA MDI, if approved by the FDA, will be sold through the company's primary care sales force. Sepracor recently completed expansion of its sales force to approximately 1,250 sales professionals in anticipation of the launch of ESTORRA™ brand eszopiclone for the treatment of insomnia, for which Sepracor received an approvable letter from the FDA on February 27, 2004. This increase in the size of Sepracor's sales force will provide improved visibility for XOPENEX inhalation solution with primary care physicians not previously reached by the sales force. It will also provide more frequent coverage of the existing prescriber base.
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical compound candidates, including candidates for the treatment of respiratory and central nervous system disorders. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits and successful development and regulatory approval of the XOPENEX HFA MDI, ESTORRA brand eszopiclone and Sepracor's other pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the results of clinical trials with respect to the XOPENEX HFA MDI and Sepracor's other products under development; the timing and success of submission, acceptance and approval of regulatory filings, including the NDA for the XOPENEX HFA MDI; the scope of Sepracor's patents and the patents of others; the commercial success of Sepracor's products; the ability of the company to attract and retain qualified personnel; the performance of Sepracor's licensees; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in Sepracor's quarterly report on Form 10-Q for the quarter ended March 31, 2004 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
Xopenex is a registered trademark and Xopenex HFA and Estorra are trademarks of Sepracor Inc. Proventil is a registered trademark of Schering Corporation.
For a copy of this release or any recent release, visit http://www.prnewswire.com/comp/780960.html or http://www.sepracor.com/.
Contacts: David P. Southwell Executive Vice President Chief Financial Officer Sepracor Inc. Jonae R. Barnes Vice President Investor Relations Sepracor Inc. (508) 481-6700