Forest reports positive phase III aclidinium bromide results

Forest Laboratories and Laboratorios Almirall have announced the results from two phase III clinical studies of aclidinium bromide as a treatment for chronic obstructive pulmonary disease (COPD) patients.

In the Acclaim/COPD I&II trials, the novel long-acting inhaled anticholinergic showed statistical significance when compared to placebo with the primary endpoint of trough FEV1 – a measure of pulmonary function.

The effect of the compound was maintained through one year, with the improvement of trough FEV1 at weeks 12 and 28 in the range of 60-70ml and the change from baseline in peak FEV1 at 12 and 28 weeks from 154-177ml.

Per-Olof Andersson, executive director of research and development of Almirall, said: “The studies confirm the bronchodilatory effect of aclidinium at the dose tested, although the magnitude was lower than seen in previous studies.”

He added that the company is cooperating with members of the Acclaim/COPD steering committee and Forest to determine the best way forward

Forest said it was pleased with the results of the trials and restated its commitment to the development of the compound in this indication.

In July 2008, Forest Laboratories announced positive results for Namenda (memantine HCl) as a treatment for Alzheimer’s disease.