New Nebulizer Medication -Ensifentrine - Approved for Treatment Of COPD
Background
COPD is characterized by narrowing (obstruction) of the airways as shown in the rigth panel below. Current inhaled therapies for the treatment of COPD include two classes of bronchodilators - beta2-agonists and muscarinic antagonists - and inhaled conticosteroids. The different bronchodilators are available as both short-acting (last about 4 hours) and long-acting (last 12 to 24 hours). However, no novel (or different) therapies have been approved for COPD in at least 20 years.
On left, normal lung tissue with open airway (breathing tube) in the center; On right, damage to the lung as occurs in COPD: 1. green mucus blocks airflow; 2. disrupted attachments cause collapse of airways, and 3. inflammation and fibrosis (scarring) of the airway wall. All three processes contribute to narrowing of the airways.
FDA Approval
On June 26, 2024, the U.S. Food and Drug Administration approved ensifentrine (brand name: Ohtuvayre) for the maintenance treatment of patients with COPD. Ensifentrine is a new class of medication that acts a “selective inhibitior of phosphodiesterase (PDE) 3 and 4.”
Woman using a nebulizer breathing normally in and out to inhale liquid medication
Nebulizer motuhpiece and cup
How Does Ensifentrine Work?
Inhibition of PDE3 promotes bronchodilation (opening the airways)
Inhibition of PDE4 reduces airway inflammation (redness and swelling).
The results of a phase III study showed that ensifentrine significantly improved lung function (breathing tests), relieved shortness of breath, and reduced the risk of an exacerbation in two separate but identical studies (ENHANCE 1 - 760 subjects; ENHANCE 2 - 789 subjects).
Red bar on left shows greater relief of shortness of breath with ensifentrine compared with placebo in blue-green bar on right. A change of +1 in the Transition Dyspnea Index (TDI) is considered the minimal important difference.
Will Ensifentrine Be First-line Or Add-on Therapy?
Most likely, ensifentrine will be added on to a patient’s current inhaled therapies such as two different bronchodilators (like Anoro, Bevespi, and Stiolto) or inhaled triple therapy (two bronchodilators and inhaled corticosteroids - like Breztri and Trelegy). Why? It is expected that ensifentrine will act to reduce shortness of breath because it works in a different way than the other inhaled medications.
My Comments
As noted above, ensifentrine is inhaled by the patient using a nebulizer (shown above). A nebulizer and its equipment along with nebulizer medications are covered by Medicare Part B insurance. However, some nebulizer medications require a person to have supplemental medical insurance for more complete coverage.
If you have COPD and continue to experience shortness of breath with daily activities, ask your health care professional and/or pulmonologist whether ensifentrine is an option.