(RxWiki News) The US Food and Drug Administration (FDA) has approved a new inhaler for COPD.
This medication is found under the name Breztri Aerosphere. This newly approved inhaler includes three medications: budesonide, glycopyrrolate and formoterol fumarate.
Available as an inhaler, this medication is approved as a maintenance treatment for chronic obstructive pulmonary disease (COPD) to promote better breathing and fewer flare-ups.
COPD is a group of lung diseases (emphysema and chronic bronchitis) that causes the blockage of airflow and breathing-related problems. An estimated 16 million Americans have COPD. Although there is no cure, COPD can be treated.
The recommended dose of Breztri Aerosphere is two puffs two times each day.
This medication is not to be used to relieve sudden breathing problems. In other words, it will not replace a rescue inhaler.
This medication is not approved as a treatment for asthma.
Common side effects of Breztri Aerosphere may include upper respiratory tract infections, pneumonia, flu, back pain, muscle spasms, cough, inflammation of the sinuses, urinary tract infection and diarrhea.
This medication may also cause a fungal infection of the mouth and throat (called thrush). To help reduce the chances of thrush, experts recommend that you rinse your mouth with water without swallowing after using the inhaler.
Tell your doctor about all the medications you take, including prescription drugs, over-the-counter medications, and herbal and nutritional supplements. This medication may interact with other medications.
This medication's approval was actually denied in October, when the company only had data from the Phase III KRONOS trial.
This recent approval was based on positive results from the Phase III ETHOS study. The data seen in the Phase III KRONOS trial also supported this approval.
The most recent trial of Breztri Aerosphere revealed a reduction in the rate of moderate or severe COPD exacerbations when compared with specific COPD treatments.
This medication's approval was granted to AstraZeneca.
Speak with your health care provider if you have any questions.
