BARCELONA, Spain Almirall has introduced a new, state-of-the-art dry-powder inhaler, which the company will market with its leading pipeline compound aclidinium bromide. The drug is designed for treating chronic obstructive pulmonary disease, which include diseases like chronic bronchitis and emphysema.
The drug is currently in Phase III trials with 1,600 COPD patients from 23 countries worldwide. The results of the trials will be announced at the 2008 American Thoracic Society meeting.
Almirall is pursuing a three-line strategy for aclidinium bromide. It is being developed initially as a once-daily monotherapy for first-line maintenance therapy in COPD and will be filed with regulators for this indication in 2009. It is also in phase II trials in a fixed-dose combination with the long-acting beta agonist formoterol. This is expected to be filed in 2011. Additionally, it is at a preclinical development stage as a fixed-dose combination with an inhaled corticosteroid, which could be ready to file in 2012.
Almirall’s director of pharmaceutical development, Carsten Niederlaender, said the inhalation device will appeal to patients and healthcare professionals because “it is small, compact, portable, preloaded and extremely easy to use—unlike some of the currently available inhalers for COPD medications. Patients merely have to remove the cap, press the dose-release button and inhale. It should therefore improve patient adherence. The device, which comes preloaded with 30 doses, has a window that changes from red to green when a dose has been effectively delivered and which registers an audible click, providing patients with feedback and reassurance. A dose indicator flags up a red signal to warn patients when the inhaler is close to empty and the device locks out when its 30-day supply is exhausted to prevent patients inhaling inert dry-powder residue. The new inhaler is one of very few that ticks all the boxes for complying with international regulatory requirements,” said Niederlaender.