FDA Approves Daliresp Dosage as First-line Therapy for Severe COPD

AstraZeneca’s Daliresp (roflumilast) is now approved at 250 micrograms (mcg) for the first four weeks followed by 500 mcg thereafter to treat patients with chronic obstructive pulmonary disease (COPD). This approval by the U.S. Food and Drug Administration (FDA) will help reduce the rate of discontinuation previously reported in patients undergoing Daliresp treatment.

The FDA based its ruling on results of the Phase 3 OPTIMIZE study (NCT02165826). The trial enrolled 1,323 patients with severe COPD associated with chronic bronchitis who had at least one exacerbation episode in the previous year.

The 12-week trial compared the discontinuation rates of Daliresp in COPD patients divided into three experimental groups. In the first group, 443 patients received 500 mcg of Daliresp every day for 12 weeks. In the second group, 439 patients were first treated with 500 mcg every other day for four weeks, followed by Daliresp 500 mcg once a day for eight weeks. And in the third, 441 patients received Daliresp as a 250 mcg oral, daily dose during the first four weeks, followed by daily administration at 500 mcg for the remaining eight weeks.

Results showed that treating patients initially with a 250 mcg daily dose of Daliresp before undergoing the full, therapeutic dose of 500 mcg led to a significantly lower percentage of patients discontinuing treatment (18.4 percent) compared to those treated with Daliresp at 500 mcg once a day for 12 weeks (24.6 percent).

Whether starting Daliresp at 250 mcg improves the long-term tolerability of Daliresp 500 mcg remains inconclusive, as the trial evaluated the therapy’s efficacy for only 12 weeks.

Previous clinical trials showed that the most common adverse reactions to Daliresp were diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.

Daliresp is an FDA-approved therapy to reduce the exacerbation risk in COPD patients with chronic bronchitis and a history of exacerbations. The 250 mcg dose is evaluated as a starting, add-on dose since it does not carry the therapeutic value of the 500 mcg dose.

“As the only once-daily tablet to provide enhanced protection against COPD exacerbations when added to current bronchodilator therapy, this is an important new dosing option to help patients start and stay on treatment,” Tosh Butt, vice president of AstraZeneca’s respiratory unit, said in a press release provided to COPD News Today. “Exacerbations are associated with hospitalizations and an accelerated decline in lung function, and these patients living with COPD need effective treatment options.”