Pearl Therapeutics Announces Positive Results From Phase 2a Trial of Formoterol Inhalation Aerosol in Chronic Obstructive Pulmon
Posted Jan 04 2010 8:47am
– Company’s First Clinical Trial in COPD; Demonstrates Safety and Efficacy of Formoterol Fumarate Delivered by Pearl’s Proprietary High-Performance Metered Dose Inhaler (MDI) Product –
Pearl Therapeutics Inc., a company developing high-quality combination therapies for the treatment of highly prevalent chronic respiratory diseases, today announced positive results from its first clinical trial in patients with chronic obstructive pulmonary disease (COPD). Results from a Phase 2a dose-ranging study of PT005, the company’s formoterol fumarate hydrofluoroalkane metered dose inhaler (HFA-MDI) formulation, showed that it was well tolerated with bronchodilator efficacy and safety outcomes comparable to the active control drug Foradil® Aerolizer® (formoterol from a capsule-based, unit dose, dry powder inhaler). Pearl plans to present results from the Phase 2a study of PT005 at a future medical conference.
Formoterol fumarate is a well-known, established, long-acting beta2 agonist (LABA) bronchodilator that is indicated for the management of asthma and COPD and administered twice daily. It exhibits rapid onset and an excellent response. One of the most potent inhaled drugs with doses in the single-digit microgram range, formoterol fumarate has been difficult to formulate in an MDI, the most widely used inhalation drug delivery format. Pearl has overcome fundamental chemistry, manufacturing and control (CMC) issues associated with MDIs via proprietary porous particles that result in highly stable, robust and aerodynamically efficient formulations. Pearl has developed a broad portfolio of high-performance combination and monotherapy MDI products utilizing this formulation platform, without the need for complex devices or manufacturing processes.