The FDA approved the inhaler treatment based on 2 Phase III-B studies running 6 months and 12 months, respectively, to compare the drug’s efficacy in COPD exacerbation care.
The US Food and Drug Administration (FDA) has approved an update to the label of chronic obstructive pulmonary disease (COPD) treatment budesonide/formoterol fumarate dehydrate (SYMBICORT) to indicate its reduction of COPD exacerbations.
SYMBICORT, by pharmaceutical company AstraZeneca, is a pressurized metered dose inhaler (pMDI) 160/4.5 micrograms and fromoterol 4.5 micrograms, administered as 2 inhalations per day for treating exacerbations in moderate-to-severe COPD adult patients.
The FDA approved the inhaler treatment based on 2 Phase III-B studies running 6 months and 12 months, respectively, to compare the drug’s efficacy in COPD exacerbation care. SYMBICORT supplementally treats chronic bronchitis and emphysema, but is not indicated for acute bronchospasm relief.
The most commonly reported adverse effects in COPD clinical trials included bronchitis, sinusitis, upper respiratory tract infection, and other conditions. However, the rate of adverse effects did not exceed 3% of the studied patient population.
Frank Trudo, USMA Respiratory Brand Medical Lead, said the "important indication" allows AstraZeneca to communicate to healthcare providers the impact SYMBICORT has in helping reducing COPD exacerbations, which is "an important outcome to avoid for those who are being treated for COPD."
"This marks the second new indication for SYMBICORT in 2017, which illustrates our commitment to follow the science," Trudo said.
According to AstraZeneca, more than 14 million people in the US were diagnosed with COPD as of 2010, and another 12 million people have not been diagnosed.