ALKS 27 is an inhaled formulation of trospium chloride based on Alkermes' AIR pulmonary technology. The study will assess the safety, tolerability, pharmacokinetics and efficacy of single doses of ALKS 27.
As an inhaled formulation of trospium chloride, a muscarinic receptor antagonist that relaxes smooth muscle tissue, the companies believe ALKS 27 could potentially improve airflow and provide a new treatment option for patients with chronic obstructive pulmonary disease (COPD).
“By combining our proprietary AIR technology and Indevus' trospium chloride, a molecule with a known safety profile and proven efficacy in an approved indication, we hope to bring forward a more patient-friendly treatment option for people with COPD,” stated Elliot Ehrich, chief medical officer of Alkermes.
The efficacy of ALKS 27 will be evaluated based on improvements in pulmonary function in patients with COPD. This phase IIa study follows completion of a phase I study which demonstrated that ALKS 27 was well tolerated over a wide dose range, with no dose-limiting effects observed. Alkermes and Indevus expect to report results from the study in the second half of 2007.