US FDA approves Dey's Perforomist

US drugmaker Critical Therapeutics says that the Food and Drug Administration has approved Dey's New Drug Application 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.

Under the terms of their binding letter of agreement, Critical Therapeutics and Dey, which is an affiliate of Germany's Merck KGaA, will jointly promote Perforomist in the USA. In order to participate in the promotion of the product, 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 the asthma drug zileuton.

Formoterol is a rapid and long-lasting beta-2 agonist that has been previously approved in the USA as a dry-powder formulation, and the molecule has 20 years of worldwide use. Perforomist is the first and only FDA-approved form of the drug for use in a nebulizer, which converts liquid medications into a mist that patients inhale through a mouthpiece or face mask. "The approval of Perforomist enhances the prospective efficiency of our sales force by providing representatives with a second product that directly complements our respiratory franchise," noted Frank Thomas, chief executive officer of Critical Therapeutics.