FDA approves roflumilast for severe COPD

March 2, 2011

FDA approved the first-and-only selective phosphodiesterase type 4 inhibitor roflumilast (Daliresp, Forest Pharmaceuticals), once-daily oral tablet to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease.

FDA approved the first-and-only selective phosphodiesterase type 4 (PDE-4) inhibitor roflumilast (Daliresp, Forest Pharmaceuticals), once-daily oral tablet to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD that involves primary emphysema.

Last April, FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10 to 5 that safety and efficacy data were not strong enough to approve the drug as maintenance treatment for COPD patients with chronic bronchitis who are at risk of exacerbations, MedPage Today reported. Among patients taking roflumilast in clinical trials, 14% discontinued the drug because of side effects that included weight loss, psychiatric events including suicide, and the potential for cancer.

“The FDA Advisory committee was not favorable to this drug last year so its approval by FDA creates somewhat of a quandary as to the true medical usefulness of this product, let alone potential safety concerns,” Randy Vogenberg, PhD, principal at the Institute for Integrated Healthcare in Sharon, Mass., and executive director of the Biologic Access & Finance program at The Jefferson School of Population Health in Philadelphia, told Drug Topics.

“Newer biologic products such as this will offer a mixed value proposition to health plan sponsors making it difficult to predict a marketing slam dunk for such products,” Vogenberg said.

The safety and effectiveness of roflumilast was demonstrated in 2 phase 3 clinical studies that included more than 1,500 patients aged 40 years and older who received roflumilast. 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.

FDA approved roflumilast with 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.

Roflumilast should not be used to treat sudden breathing problems (acute bronchospam), and is not recommended for people younger than 18 years. The most common side effects reported by those receiving roflumilast included diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.