BRIDGEWATER, NJ -- (Marketwire) -- 01/07/13 -- Aptalis Pharma, Inc., a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis (CF), announced the results of two global Phase 3 studies of Aeroquin (levofloxacin inhalation solution). The two studies were conducted in cystic fibrosis patients with stable chronic lung infection with Pseudomonas aeruginosa. They followed a successful placebo-controlled dose-finding study that demonstrated a dose-dependent pronounced reduction in the sputum density of Pseudomonas aeruginosa and improvement of lung function in the same patient population [Geller DE et al, Am J Respir Crit Care Med. 2011 Jun 1;183(11):1510-6].
In one Phase 3 study (Study 207) conducted in 330 patients, Aeroquin, delivered by a customized nebulizer using eFlow technology (PARI Pharma GmbH) at a dose of 240 mg twice daily, was compared to placebo in a double-blind, randomized single treatment-cycle of 28 days. In the second Phase 3 study (Study 209) conducted in 282 patients, the same dose of Aeroquin was compared to tobramycin for inhalation solution (TIS) in a randomized open-label study of three 28-day on/off treatment cycles. In both studies, patients had been heavily pretreated with inhaled antibiotics prior to enrollment.
In the TIS-comparator study, the primary endpoint -- non-inferiority of relative change from baseline in percent predicted Forced Expiratory Volume in 1 Second (FEV1) after the first treatment cycle of 28 days -- was met. This effect with Aeroquin on lung function was maintained over all three treatment cycles (i.e., through Day 168). For other clinically relevant secondary endpoints, such as quality-of-life measures and time to pulmonary exacerbation, the effect of Aeroquin was measurably similar or superior to TIS. An open-label extension study of Study 209 is ongoing.
In Study 207, the placebo-controlled single-cycle study, the differences between Aeroquin and placebo groups in the predefined primary endpoint of time to first pulmonary exacerbation were not statistically significant, however efficacy among certain secondary endpoints (lung function, reduction in Pseudomonas aeruginosa from sputum) in Aeroquin treated patients was demonstrated.
Tolerability and safety of Aeroquin was consistent across all three studies and showed similarity to TIS and placebo, respectively, with the exception of dysgeusia being observed more frequently in the Aeroquin group, attributable to the metallic taste of the active ingredient, levofloxacin.
Frank Verwiel, M.D., President and Chief Executive Officer of Aptalis Pharma, stated, "We are pleased with these results, which suggest that Aeroquin is potentially an important new treatment option for cystic fibrosis patients with chronic airways infection. Additional classes of inhaled antimicrobials are needed to ensure such options are available. We are looking forward to taking the next steps toward a regulatory filing for Aeroquin as part of our broader mission: to improve health and quality of care by providing specialty therapies for patients around the world."
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