FDA Advises Approval for New COPD Drug

Aclidinium bromide recommended for approval by FDA advisory panel

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(RxWiki News) More relief from Chronic Obstructive Pulmonary Disease (COPD) is just around the corner. The Food and Drug Administration (FDA) has recommended approval for a new COPD drug.

The FDA's advisory panel has ruled that aclidinium bromide should be approved for general use. The twice daily medication could bring relief to the millions of COPD sufferers in America. Aclidinium bromide reduces a number of symptoms including breathlessness and excess mucus.

"Ask your doctor about what inhalers are available for COPD treatment."

While the recommendation for approval of aclidinium bromide for COPD was made by the FDA advisory panel, the FDA regularly follows the panel's decision. Aclidinium bromide will be developed by Forest Laboratories Inc. and Almirall SA for public use. No word yet on how much the drug will cost.

In clinical trials aclidinium bromide was shown to be effective and safe for COPD users. Aclidinium bromide relieved cough, breathlessness, chest heaviness and excess mucus in COPD patients for as long as 24 hours. Aclidinium bromide will be a twice daily medication.

Side effects for aclidinium bromide use included an increased risk of adverse heart events. This risk for heart problems were found only in COPD patients who were using the highest dosage of aclidinium bromide. The panel advised for a long-term study, between one and two years, of aclidinium bromide to make sure the drug did not create severe heart problems in patients and that there were no rare side effects.

Aclidinium bromide works by preventing the smooth muscles in the lungs from contracting. This allows for more air to flow through the airways which lets COPD patients breathe better.

While aclidinium bromide may be all set for approval, COPD patients will have to wait until 2015, depending on the approval process. Aclidinium bromide will delivered using the Genuair inhaler developed by Almirall SA. The Genuair inhaler features audio and visual cues letting patients know if the dose was taken properly.

Pending approval, aclidinium bromide could be another effective treatment for COPD. Nearly 12 million Americans have COPD, according to the National Institutes of Health, and new treatments are needed to provide relief from COPD symptoms.

Last Updated:
February 24, 2012