07.11.2005 05:01:00
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Alcon Presents New Clinical Data and Provides Regulatory Update on PATANASE(R) Nasal Spray
"PATANASE(R) nasal spray's fast onset of action and symptomcontrol would be important benefits for allergy sufferers, who seekquick relief from their debilitating symptoms," said Bob Q. Lanier,MD, medical director, Lanier Education and Research Network, andclinical professor, Division of Pediatric Allergy & Immunology,University of North Texas Health Science Center.
Study Overview and Results
The controlled allergy study included 425 patients with a historyof seasonal allergic rhinitis and sensitivity to ragweed. Patientswere randomized to a single intranasal dose of either PATANASE(R)nasal spray, NASONEX(a) nasal spray, or placebo spray. Patients werethen exposed to 12 hours of high levels of ragweed in an environmentalchamber.
The primary goal of the study was to measure total nasal symptomscore (TNSS), defined as the sum of patients' assessment of runnynose, itchy nose, stuffy nose (congestion) and sneezing, over a12-hour period after a single dose of study medication. Secondaryvariables were changes from baseline in severity scores for theindividual symptoms and participant assessment of global efficacy.
Results included:
-- PATANASE(R) nasal spray demonstrated an onset of action as early as 30 minutes in the treatment of seasonal allergic rhinitis.
-- PATANASE(R) nasal spray was superior to placebo spray for the overall measure of TNSS compared to baseline at all time points (30 minutes through 12 hours post dose).
-- PATANASE(R) nasal spray was superior to placebo spray at all time points for stuffy nose and sneezing and 15 of 16 time points for runny nose and itchy nose.
-- PATANASE(R) nasal spray was superior to NASONEX(a) nasal spray at 13 of 16 time points (60 minutes through 10 hours post dose) with regard to TNSS.
-- For individual symptoms, PATANASE(R) nasal spray was superior to NASONEX(a) nasal spray at a majority of time points for stuffy nose, runny nose and itchy nose.
-- Overall, study participants rated PATANASE(R) nasal spray as providing "better" symptom relief than NASONEX(a) nasal spray and placebo spray.
"PATANASE(R) nasal spray is steroid-free and in clinical studieshas demonstrated an acceptable taste profile and low sedationpotential. This profile and the study's results are encouraging ashealthcare providers continue to seek future treatment options fortheir patients who suffer from seasonal allergic rhinitis symptoms,"said G. Michael Wall, PhD, Alcon's senior director of otic/nasalproduct development.
Adverse events in this study were non-serious. These were tasteperversion (2 patients) for the PATANASE(R) nasal spray group,headache (2 patients) for the NASONEX(a) group and rhinitis andincreased cough (2 patients each) for the placebo group.
Regulatory Update
Alcon filed a New Drug Application (NDA) for PATANASE(R) nasalspray for the treatment of seasonal allergic rhinitis in December of2004. The company said it has received correspondence from the U.S.Food and Drug Administration (FDA) requiring that the currentformulation of the drug be modified to reduce or remove one of theinactive ingredients it contains before PATANASE(R) nasal spray can beapproved. The company has developed and is testing a modifiedformulation, which it believes will maintain the same level ofefficacy while resolving the agency's concerns. As previouslycommunicated, the company anticipated it would be required to provideadditional information to the FDA in order to gain approval of thedrug.
"The studies we did in support of our filing showed a high levelof efficacy for PATANASE(R) nasal spray and we look forward to meetingwith the FDA in the near future to discuss items in the letter and toconfirm what data and information will be required to gain approval ofthe new formulation. We believe the letter and our upcoming meetingwill set out a pathway for approval of PATANASE(R) nasal spray," saidDr. Gerald Cagle, PhD, senior vice president of research anddevelopment.
About Seasonal Allergic Rhinitis
Seasonal allergic rhinitis, also known as "hay fever," refers toan allergic complex of symptoms caused by sensitivity to seasonalpollens. Symptoms may include congestion, sneezing, itchy nose, runnynose, watery eyes and itchy eyes.
According to ACAAI, allergies affect an estimated 40 to 50 millionpeople in the United States. Allergies are not only bothersome, buthave been linked to a variety of common and serious chronicrespiratory illnesses, such as sinusitis and asthma. In addition, theymay interfere with day-to-day activities or lessen the quality oflife.
About Alcon
Alcon, Inc. is the world's leading eye care company with salesexceeding $3.9 billion in 2004.
Alcon, which has been dedicated to the ophthalmic industry forover 50 years, develops, manufactures and markets pharmaceuticals,surgical equipment and devices, contact lens solutions and othervision care products that treat diseases, disorders and otherconditions of the eye. For more information on Alcon, Inc., visit thecompany's Web site at www.alconinc.com.
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within themeaning of the Private Securities Litigation Reform Act of 1995,relating principally to our ability to gain FDA approval ofPATANASE(R) nasal spray and its expected benefits in treating seasonalallergic rhinitis. These statements involve known and unknown risks,uncertainties and other factors which may cause our actual results,performance or achievements to be materially different from any futureresults, performances or achievements expressed or implied by ourforward-looking statements. These statements reflect the views of ourmanagement as of the date of this press release with respect to futureevents and are based on assumptions and subject to risks anduncertainties. Given these uncertainties, you should not place unduereliance on these forward-looking statements. Factors that might causefuture results to differ include, but are not limited to, thefollowing: we may never receive FDA approval of our NDA forPATANASE(R) nasal spray; approval of the NDA may take longer than weexpect; treatments developed by other companies may be or may beperceived to be more effective than PATANASE(R) nasal spray;challenges inherent in new product marketing may adversely affect ourability to market the drug; and government regulation and legislationcould have an impact on our business beyond our control. You shouldread this press release with the understanding that our actual futureresults may be materially different from what we expect. Except to theextent required under the federal securities laws and the rules andregulations promulgated by the Securities and Exchange Commission, weundertake no obligation to publicly update or revise any of theseforward-looking statements, whether to reflect new information orfuture events or circumstances or otherwise.
(a) NASONEX is a registered trademark of Schering Corporation,Kenilworth, N.J.
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