FDA approves Daliresp 250 µg as starting dose for severe COPD

AstraZeneca recently announced that the FDA has approved once-daily Daliresp 250 µg as a starting dose for the initial 4 weeks followed by 500 µg to reduce treatment discontinuation in patients with severe COPD.

“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, Respiratory, AstraZeneca, said in a press release. “Exacerbations are associated with hospitalizations and an accelerated decline in lung function, and these patients living with COPD need effective treatment options.”

The approval was based on a 12-week study. The analysis revealed a significant reduction in treatment discontinuation in patients who received 250 µg of Daliresp (roflumilast, AstraZeneca) once daily for 4 weeks then 500 µg once daily for 8 weeks, compared with those who received 500 µg of roflumilast once daily for 12 weeks (18.4% vs. 24.6%; OR = 0.66; 95% CI, 0.47-0.93). The researchers were unable to determine if the initial 250 µg dose of roflumilast enhanced the tolerability of the 500 µg dose of roflumilast long-term due to the short study duration.

Eight controlled clinical trials found that diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite were the most common adverse reactions due to roflumilast.

AstraZeneca warned that roflumilast is not a bronchodilator and should not be used to relieve acute bronchospasm.