Alcon, Inc. announced that it has submitted to the US Food and Drug Administration (FDA) an amendment to its pending new drug application (NDA) for Patanase (olopatadine hydrochloride) nasal spray. The pending NDA is for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents twelve years of age and older.
The amendment includes interim six-month data from an agreed-upon study previously requested by the FDA to support a modification of the formulation of Patanase nasal spray, the company said.
"I am happy to see that Patanase is moving forward to FDA review because I believe it will provide an attractive treatment option for patients with seasonal allergic Rhinitis. Data collected through multiple studies that make up the current NDA demonstrate that Patanase provides rapid relief from bothersome nasal allergy symptoms," said, Dr. Rohit Katial, a principal investigator for Patanase and Associate Professor of Medicine, National Jewish Medical and Research Centre, Denver, Colorado.
The active ingredient in Patanase nasal spray, olopatadine hydrochloride, is the same active ingredient used in Alcon's market-leading family of products for ocular allergies, which includes Pataday ophthalmic solution and Patanol ophthalmic solution. Previous clinical studies of the nasal formulation of olopatadine hydrochloride demonstrated the efficacy of Patanase nasal spray in the treatment of the symptoms of seasonal allergies, said, the company press release.
"Patanase represents an opportunity for Alcon to enhance its portfolio of topical anti-allergy treatments and support the growth of our pharmaceutical business. We will provide the FDA with additional data during their review of our amended NDA, including the final results of the requested study," said Kevin Buehler, 's senior vice president, global markets and chief marketing officer, Alcon.
Rhinitis, the medical term for nasal allergies, refers to an allergic complex of symptoms caused by sensitivity to pollens, mold, dust or animal dander. Symptoms may include congestion, sneezing, itchy nose, excess mucus, watery eyes, itchy eyes, sinus headaches and a scratchy palate and throat. Allergies can affect people seasonally or throughout the year.
According to the American Academy of Allergy, Asthma and Immunology, allergies affect as many as 40 to 50 million people in the United States. Incidence has risen significantly in the last two decades. At least 35.9 million Americans have seasonal allergic rhinitis, resulting in approximately 16.7 million office visits to health care providers each year. Allergies are not only bothersome, but have been linked to a variety of common and serious chronic respiratory illnesses, such as sinusitis and asthma.
Alcon, Inc. is the world's leading eye care company, with sales of approximately US $4.9 billion in 2006. Alcon, which has been dedicated to the ophthalmic industry for 60 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon's majority shareholder is Nestle, S.A., the world's largest food company.