Recently, a brand new medication was approved for use in the United States by the Food & Drug Administration (FDA, for short). The drug’s chemical name is Roflumilast, but is being marketed under the name Daliresp by New York City-based Forest Laboratories. It is specifically designed for people with severe COPD associated with chronic bronchitis and a history of exacerbations.

More than 12 million people in the United States have been diagnosed with COPD. Approximately one-third of people who have COPD, or 4 million, have severe disease. And almost three-quarters, or 2.8 million, of those with severe COPD also have chronic bronchitis.

How it Works

Daliresp blocks an inflammation-causing enzyme called phosphodiesterase type 4 (called PDE4 for short). People who have COPD tend to have way too much of this enzyme in their bodies. Left unchecked, PDE4 can result in a blockage of the airways.

Daliresp is NOT a steroid or a bronchodilator, though, and should never be used to treat acute bronchial spasms or shortness of breath “attacks”. It is meant to be used, as prescribed, on a regular, ongoing basis.

It is an oral medication (pill) that is taken once daily.

Who Should Take It

Your personal physician will make the ultimate decision on whether Daliresp is the right choice for you, but in general, this new medication is designed to help people severe levels of COPD avoid further exacerbations, or flares.

Studies have shown that it is effective in preventing flares and complications such as chronic bronchitis. It has been proven to reduce the frequency of flares by as much as 17 percent.

It should not be used to treat the onset of sudden breathing problems, nor is it recommended for people younger than age 18. It also should not be taken by people who have liver impairment (but that is true of most drugs, as the liver is involved in breaking down medications).

Possible Side Effects

However, like most drugs, Daliresp can have side effects. The safety of Daliresp was measured in eight different clinical trials with 4,425 people who took the medication. Less than 10 percent of the study participants experienced side effects.

These are the known common side effects for Daliresp:

• Diarrhea
• Nausea
• Headache
• Insomnia
• Back pain
• Loss of appetite
• Dizziness

Less common, but more serious side effects may include changes in mood, thinking or behavior, and unexpected weight loss. Often side effects from drugs will subside over time as your body gets used to this new chemical. But any time you have an unexpected or undesirable effect from a medication, it’s wise to call the doctor to discuss whether you should continue with it.

Availability

Daliresp should be available now or within a short time, as Forest Laboratories estimated its release in the second quarter of 2011, which began April 1st.

In Summary

Daliresp is the only PDE4-inhibitor available today, so it offers significant promise in the treatment of COPD over existing therapies. If you are looking to enhance your COPD treatment, you may want to discuss Daliresp with your doctor next time you go in for an office visit.