Boehringer Ingelheim’s Striverdi Respimat (olodaterol) Inhalation Spray for COPD Maintenance Gets FDA Approval

Boehringer Ingelheim’s Striverdi Respimat (olodaterol) Inhalation Spray for COPD Maintenance Gets FDA Approval

Boehringer IngelheimThe U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Striverdi® Respimat® (olodaterol) Inhalation Spray 5 µg to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

COPD, a pulmonary disease that restrains airflow to the lungs, affects about 26 million Americans, killing one person every four minutes. It is the third leading cause of death in the US. COPD is characterized by shortness of breath and coughing and tends to deteriorate throughout time.

The successful approval of STRIVERDI RESPIMAT originates from data relative to the Olodaterol clinical trial, a 6 and 48-week Phase III study that involved more than 4,900 patients suffering from moderate to severe COPD receiving a once daily dose of olodaterol 5 µg versus placebo. Patients who received the treatment showed significant improvements in lung function, accessed by forced expiratory volume in one second (FEV1). Throughout the duration of the study, all patients received usual care background therapy, including long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthines. Efficacy data from the trial revealed that this drug has a rapid onset of action and maintains lung function over 24 hours, with an increased number of COPD patients able to achieve clinically improvements in their quality of life.

“The approval of STRIVERDI RESPIMAT marks another step forward for our diverse respiratory pipeline that includes other compounds being evaluated using the Respimat® inhaler,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. in the company’s press release. “Boehringer Ingelheim has been a leading provider of treatments for people living with COPD for more than a decade, and we are continuing to investigate therapies that may provide additional benefits, including a Phase III program evaluating a fixed-dose combination of olodaterol and tiotropium.”

STRIVERDI RESPIMAT is a once-daily maintenance bronchodilator that belongs to the family of long-acting beta-adrenoreceptor agonists (LABAs). These agents reduce the need for shorter-acting β2-agonists due to their longer duration of action, a property that makes them ideal candidates for sparing high doses of corticosteroids. Importantly, this newly approved drug cannot be used to treat acute deteriorations of COPD or asthma.

“In clinical practice, many COPD patients are likely to be on more than one therapy to treat airflow obstruction. The Boehringer Ingelheim studies with olodaterol are important from a clinical perspective because they provide confirmation of bronchodilation even when patients are taking other medications,” added Richard Casaburi, MD, PhD, Professor and Associate Chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center, also quoted in the press release.

Although advances in the treatment of COPD exist, there is still an unmet clinical need to reduce the impact of COPD on patients’ lives. This newly approved drug can become an encouraging improvement on current available therapies.

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