UPDATE 2-U.S. FDA OKs Forest/Almirall drug for smoker's cough

(Adds background on Forest, drug side effects, competitors, shares)

WASHINGTON, July 23 (Reuters) - Forest Laboratories Inc's inhaled treatment for smoker's cough, commonly called COPD and the fourth leading killer in America, has been approved by U.S. drug regulators, bolstering the company's plans to grow profits through new medicines.

The U.S. Food and Drug Administration approved the twice-daily drug, to be sold as Tudorza Pressair, to treat symptoms of chronic obstructive pulmonary disease (COPD), a serious lung disease that makes breathing difficult and is often caused by cigarette smoking.

Forest developed the drug, which loosens the muscles around the lungs to improve airflow, with Spanish company Almirall SA and will market it in the United States.

"The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease," said Dr. Curtis Rosebraugh, director of the FDA's Office of Drug Evaluation II.

About 14 million people in the United States and 64 million worldwide have COPD, which worsens with age and can persist even if smokers with the disease quit the habit.

The FDA was originally supposed to decide on the drug by April 23, but delayed the decision to review data. It said the drug can cause serious side effects such as increasing bronchospasm, pressure in the eyes and urinary retention.

WORLD'S THIRD KILLER

The World Health Organization forecast that COPD could be the third-leading cause of death in the world by 2030 as more people in developing countries start smoking and smoke pollution increases. Wall Street analysts have forecast that sales of COPD treatments will exceed $5 billion in 2014.

Tudorza enters an already crowded field of COPD treatments. It will compete with Boehringer Ingelheim and Pfizer Inc's Spiriva, which is also an inhaled drug that opens airways.

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UPDATE 2-U.S. FDA OKs Forest/Almirall drug for smoker's cough