COPD Treatment Inhalation Spray Approved

Boehringer Ingelheim announced Tuesday the US Food and Drug Administration (FDA) approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray to treat airflow obstruction in patients suffering from chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

It is important to note Stiolto Respimat is not indicated to treat asthma or acute COPD deterioration, nor does it replace the use of a rescue inhaler.

“Stiolto Respimat is a COPD maintenance treatment proven to be more effective than either Spiriva or olodaterol alone, with a comparable safety profile,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Patients may appreciate the benefits of a maintenance medication that improves lung function within five minutes, lasts all day and reduces the use of rescue inhalers.”

Danny McBryan, MD, Vice President, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals Inc., said, “A recent review of landmark studies indicates that loss of lung function is more accelerated in the early stages of COPD. While no treatment slows the rate of decline, maintenance treatment with Stiolto Respimat initiated at the time of diagnosis will improve lung function.”

The pivotal Stiolto Respimat trial involved more than 5,000 patients with COPD. The data showed the medication provided significant improvements in lung function (trough FEV1 and FEV1 AUC0-3h) at 24 weeks versus tiotropium and olodaterol alone.

Also, the randomized 52-week Phase III TONADO 1&2 trials (NCT01431274/NCT01431287) compared Stiolto Respimat to tiotropium Respimat 5 mcg and olodaterol Respimat 5 mcg. Furthermore, both trials were part of the TOviTO® clinical trial program involving more than 15,000 COPD patients worldwide.

As Stiolto Respimat is not indicated for asthma, it should not be administered in “acutely deteriorating COPD patients or for the relief of acute symptoms”.

Stiolto Respimat is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product. Additionally, as with other inhaled medicines, Stiolto Respimat may cause paradoxical bronchospasm that may be life-threatening.

The most common adverse reactions reported were nasopharyngitis, cough, and back pain.

Richard Casaburi, MD, PhD, professor and associate chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center commented in a news release, “Stiolto Respimat produced greater lung function improvements in terms of FEV1 compared to tiotropium and olodaterol alone in patients with COPD across a range of disease severities (GOLD 2 to 4). As a clinician, I am pleased to have a new treatment option to offer my patients.”