Critical Therapeutics' Sales Force Gains Access to a Second Product as FDA Approves Co-Promotion Partner's New Treatment for COPD
Monday May 14, 6:30 am ET
FDA Approves DEY's New Drug Application for Perforomist(TM) Inhalation Solution
LEXINGTON, Mass.--(BUSINESS WIRE)--Critical Therapeutics, Inc. (Nasdaq: CRTX - News) today announced that the U.S. Food and Drug Administration (FDA) has approved Dey, L.P.'s (DEY) New Drug Application for Perforomist(TM) (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). Perforomist(TM) Inhalation Solution was approved as a 505(b)2 New Drug Application (NDA) that cross references Foradil® in support of safety and efficacy. Under the terms of their binding letter agreement, Critical Therapeutics and DEY, an affiliate of Merck KGaA in Germany, will jointly promote Perforomist(TM) Inhalation Solution in the United States. In order to participate in the promotion of Perforomist(TM) Inhalation Solution, Critical Therapeutics must increase its sales force to at least 40 representatives, which it intends to do upon regulatory approval of its twice-daily, controlled-release formulation of zileuton (zileuton CR).
Formoterol is a rapid and long-lasting beta(2)-agonist that has been previously approved in the U.S. as a dry powder formulation, and the molecule has 20 years of world-wide use. Perforomist(TM) 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 approval of Perforomist(TM) Inhalation Solution enhances the prospective efficiency of our sales force by providing representatives with a second product that directly complements our respiratory franchise," said Frank Thomas, President and Chief Executive Officer of Critical Therapeutics. "We are very pleased about the opportunity to co-promote Perforomist(TM) Inhalation Solution and the opportunity to provide a new long-term treatment option for COPD patients."
On March 13, 2007, Critical Therapeutics and DEY entered into an agreement for the joint promotion of ZYFLO® (zileuton Tablets) and zileuton CR, which is currently under review at the FDA. Zileuton CR has a Prescription Drug User Fee Act (PDUFA) date of May 31, 2007. ZYFLO is the FDA-approved immediate-release formulation of zileuton, a four-times daily medication for asthma in patients 12 years of age and older. Zileuton CR is a twice-daily, controlled-release formulation that, upon FDA approval, will be marketed for asthma patients 12 years of age and older. Zileuton CR utilizes SkyePharma PLC's Geomatrix® technology.
About Perforomist (TM) (Formoterol Fumarate) Inhalation Solution
The clinical evaluations of Perforomist(TM) Inhalation Solution included two clinical trials involving a total of 1,045 patients. In the product's pivotal Phase III trial, 351 patients participated in a 12-week, multi-center, safety and efficacy COPD study. In the study, 123 COPD patients were treated with Perforomist(TM) Inhalation Solution 20 mcg/2 mL twice daily, 114 COPD patients were treated with the active comparator (Foradil®), and 114 COPD patients were treated with placebo. The study's results showed that Perforomist(TM) Inhalation Solution 20 mcg/2 mL taken twice daily was statistically superior to placebo for the primary endpoint, FEV(1) AUC(0-12). The safety and efficacy of Perforomist(TM) Inhalation Solution observed in this study were comparable to those of Foradil®. Additionally, patients treated with Perforomist(TM) Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo. |
