Skip to main content

FDA Approves New Drug to Treat COPD

Daliresp Will Be Sold in Pill Form to Treat Chronic Obstructive Pulmonary Disease

March 1, 2011 -- The FDA has approved a new treatment for people with worsening symptoms of severe chronic obstructive pulmonary disease (COPD), a lung disorder that makes breathing difficult.

The drug, roflumilast -- carrying the trade name Daliresp -- will be sold in pill form, unlike some other medications for COPD, which are inhaled.

The FDA says roflumilast, a new drug class for COPD treatment, is an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4).

The pill is recommended for people with severe COPD to treat symptoms of cough and excess mucus linked to bronchitis. It is not intended to treat another form of COPD, which involves primary emphysema.

The FDA's approval was announced even though the agency's advisory panel voted 10-5 on April 7, 2010, not to recommend approval of the once-daily pill. At the time the panel members decided the drug had too many adverse effects to offset what the FDA called a “modest” increase in lung function attributable to roflumilast.

The FDA approval of roflumilast requires a medication guide informing patients of the potential risks of mental health problems, including changes in mood, thinking, or behavior, as well as unexplained weight loss.
COPD Symptoms

Symptoms of COPD include breathlessness, chronic cough, and excessive phlegm.

An exacerbation can last up to several weeks and result in a decline in lung function and increased risk of death, and it may be associated with severe anxiety, the FDA says.

Cigarette smoking is the leading cause of COPD.

“COPD is a serious disease that gets worse over time,” Curtis Rosebraugh, MD, MPH, of FDA, says in a news release.

“New treatment options that reduce frequency of flare-ups or exacerbations are important in helping patients with COPD associated with chronic bronchitis and a history of exacerbations in managing this debilitating disease,” says Rosebraugh, director of the office of drug evaluation in the FDA's Center for Drug Evaluation and Research.
Side Effects

The FDA says in a news release that the safety and effectiveness of roflumilast was demonstrated in two phase III clinical trials that included more than 1,500 patients 40 and older.

The federal agency says that those treated had a history of COPD associated with chronic bronchitis and had experienced an exacerbation of the disease during the 12 months prior to beginning treatment.

The FDA says roflumilast should not be used to treat sudden breathing problems and is not recommended for people younger than 18.

The most common side effects include diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.

The medication is marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.

SOURCES:

News release, FDA.


Comments

Post a Comment

Popular posts from this blog

Final lunar eclipse of 2010 set for early morning of December 21

Skygazers hoping to catch the last lunar eclipse of 2010 on Tuesday morning best be ready to stay up late (or wake up very early) to watch the full moon as it goes through a range of dramatic color changes. The December 21 lunar eclipse is expected to last about three-and-a-half hours from its start as a partial eclipse at 1:33 a.m. ET to its finish at 5:01 a.m. ET, according to NASA. The previous lunar eclipse occurred June 26 . During a lunar eclipse, the moon, the Earth, and the sun align so that the sun's rays are shielded from the moon. An eclipse of the moon can only take place if the moon is full, and only if the moon passes through some portion of Earth's shadow, which is composed of two cone-shaped parts, one nested inside the other. The start of the total eclipse is expected around 2:41 a.m, when the entire moon passes through the Earth's umbra, or inner shadow, which blocks all direct sunlight from reaching the moon. The moon will tak...
Post a Comment
Read more

Hand, Foot and Mouth Disease (HFMD) and Onychomadesis

  Introduction Nails are underutilized as diagnostic tools, despite being involved in many dermatologic conditions. This paper explores new concepts in the treatment of median nail dystrophy (MND), onychomycosis, and the nail pathology of hand, foot, and mouth disease (HFMD). A Pubmed database literature search was conducted for MND treatment, onychomycosis treatment, and HFMD nail pathology. Only papers published after January 2008 were reviewed. The results showed that 0.1% tacrolimus ointment can be an effective treatment for MND. Early studies on laser therapy indicate that it is a safe and efficacious treatment option for onychomycosis, compared to conventional oral antifungal agents. Vicks VapoRub (The Proctor & Gamble Company, Cincinnati, OH) is effective against onychomycosis and is a reasonable option in patients who choose to forgo conventional treatments. Lastly, there is evidence to support a correlation between HFMD and onychomadesis. ...
Post a Comment
Read more

Men With Breast Cancer Face Worse Prognosis

Men who are diagnosed with breast cancer are more likely than female patients to die in the next 15 years, researchers report. "This may be due to a difference in tumor characteristics and treatment," says study leader Hui Miao, a PhD candidate at the National University of Singapore. Male breast cancer is rare, accounting for less than 1% of all breast cancers in the U.S. Given its scarcity, few studies have assessed its prognosis "and we know of no recent studies looking at trends in survival," Miao tells WebMD. So Miao and colleagues studied 459,846 women and 2,664 men diagnosed with breast cancer in Denmark, Finland, Switzerland, Norway, Singapore, and Sweden between 1970 and 2007. Among the findings, presented at the San Antonio Breast Cancer Symposium: Men were diagnosed at an older age: 69 vs. 61 for women. Twice as many men had later stage III or IV disease: 18% vs. 9% of women. Only 25% of men were alive 15 years after diagnosis, compared with 44...
Post a Comment
Read more