Napa, CA (May 11, 2007) Dey, L.P. announced today that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Perforomist (formoterol fumarate) Inhalation Solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).
Formoterol is a rapid and long-lasting beta2 agonist that has been previously approved in the U.S. as a dry powder formulation, and the molecule has twenty years of worldwide use. Perforomist Inhalation Solution is the first and only FDA-approved nebulized formoterol fumarate. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.
"The first nebulized formoterol fumarate, Perforomist Inhalation Solution offers a new treatment option to COPD patients," said Nicholas J. Gross, MD, PhD, Principal Investigator of the Phase III pivotal clinical trial and an expert on lung diseases, particularly COPD. "By nebulizing with Perforomist Inhalation Solution twice a day once in the morning and once in the evening many COPD patients can achieve better control of their disease symptoms. The convenience of such simple dosing combined with a drug delivery option favored by many patients may provide improved symptom control and a better quality of life for the millions of Americans who live with COPD."
Mel Engle, President and CEO at DEY, noted, "As the US leader in nebulized respiratory products, we are thrilled to bring Perforomist Inhalation Solution, a new patented treatment option for COPD patients, to the market. Nebulization is a time tested and reliable drug delivery option. DEY has a long history of developing and marketing innovative respiratory therapeutics. The approval of Perforomist Inhalation Solution fits perfectly with our overall strategy for respiratory medications."