The U.S. Food and Drug Administration (FDA) has approved a new medication, Stiolto Respimat, to treat chronic obstructive pulmonary disease (COPD).
The medication, developed by Boehringer Ingelheim, combines two different existing COPD drugs with complementary effects into a once-a-day inhaler.
In people with COPD, the airways have become narrowed, damaged, or partially blocked. Expanding the airways allows oxygen to make its way farther into the lungs where it can be absorbed into the bloodstream and carried to the rest of the body.
A thin layer of smooth muscle lines these airways, expanding and contracting to control their size.
Doubling up for Treatment
Tiotropium, the first drug in the new medication approved last week, targets the nerves that make these muscles constrict. When these nerves are blocked, the muscles relax, allowing the airways to expand.
Olodaterol, the second drug, takes advantage of this. It activates the body’s adrenaline system, which flushes the airways open. Without the tension from the smooth muscle tightening the airways, they can expand more fully. Olodaterol acts quickly, offering symptom relief within five minutes.
“It’s this dual thing that makes it a potent combination – fast onset of action, and the additional benefits in lung function,” said Danny McBryan, vice president of Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals Inc., in an interview with Healthline. “In the end, there’s a significant benefit shown when you add olodaterol to tiotropion.”
Clinical trials found that the drug combination produced substantially improved outcomes compared to using either drug alone.
Several existing COPD medications currently contain one or the other of these drugs – often in combination with a steroid that reduces swelling – but not both. Stiolto Respimat is the first to combine tiotropium and olodaterol.
The medication comes in a handheld inhaler, the Respimat, which patients use once a day. The inhaler itself also represents a step forward in medical technology. Previous generations of inhalers released medication at high speed and pressure, so much of the medicine was lost as it is sprayed across the patient’s mouth and throat. Respimat releases the medication as a slow mist over 1.5 seconds, allowing patients to inhale the full dose into their lungs more easily.
“We’re absolutely delighted to have the FDA approval,” said McBryan. “This is a drug that’s going to help healthcare professionals, particularly primary care physicians, in their efforts to maximize bronchodilation and opening of the airways. We know from the data that this is an effect that occurs across all severities of the condition that we studied.”
Giving Patients Options
Although Stiolto Respimat comes as one of many possible medications for COPD, it could prove to be an important new tool for physicians in helping their patients manage their condition.
“It does offer us and our patients options,” said Dr. Albert Rizzo, senior medical advisor to the American Lung Association and section chief of pulmonary/critical care medicine in the Christiana Care Health System, in an interview with Healthline. “These are slightly different types of molecules compared to drugs that are already out there. What they do is offer different options to patients who have a chronic illness who may have been on some of the earlier drugs, and were getting benefit, but maybe are looking for something that may be a little easier to take or maybe have a different effect on them.”
McBryan stresses that Stiolto Respimat reflects the directives in the latest strategy document from the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
“For me, this is an opportunity to have a call to action for physicians, particularly primary care physicians, to diagnose these patients as early as possible and treat them aggressively,” said McBryan. “This is a disabling disease with a significant associated morbidity, and it’s important to use the latest treatments that will help maximize patients’ breathing.”
Signs that you may be experiencing COPD include:
- tightness in your chest
- wheezing, whistling, or creaking sound when you breathe
- shortness of breath, especially when exercising
- persistent cough or cough that regularly brings up mucus
If you suspect you may have COPD, speak with your primary care physician to learn more.