Aclidinium bromide, a long-acting anticholinergic bronchodilator, has been approved as a treatment for chronic obstructive pulmonary disease, for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, the Food and Drug Administration announced on July 23.
The product, a dry powder inhaler used twice a day, will be marketed as Tudorza Pressair by Forest Pharmaceuticals, a subsidiary of Forest Laboratories. A statement released by Forest Laboratories said that the product was expected to become available to wholesalers in the fourth quarter of 2012. The inhaler delivers 60 doses of aclidinium bromide powder for inhalation, the statement said.
Approval was based on three randomized, placebo-controlled, confirmatory clinical trials, which included 1,276 patients aged 40 years and older diagnosed with COPD. At a meeting in February 2012, the majority of the FDA’s Pulmonary-Allergy Drugs Advisory Committee agreed that the data in clinical trials provided evidence that this dose had a clinically meaningful benefit in patients, citing the significant increases in trough forced expiratory volume in 1 second (FEV1) from baseline (the primary efficacy end point) among those treated with 400 mcg twice a day, compared with those on placebo after 12 weeks of treatment in clinical studies.
The most common side effects reported by patients treated with aclidinium bromide included headache, nasopharyngitis, and cough. Serious adverse effects associated with treatment include paradoxical bronchospasm, new or worsened acute narrow-angle glaucoma, or new or worsened urinary retention, according to the FDA statement.
Forest Laboratories licensed the U.S. rights for aclidinium from Almirall, a pharmaceutical company based in Spain. In May, the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for approval of aclidinium for treating COPD in the E.U., where it will be marketed as Eklira Genuair, according to Almirall.