FDA OKs Mist Spray Form of Tiotropium (Spiriva Respimat )

September 25, 2014

The US Food and Drug Administration (FDA) yesterday approved an inhalation spray version of tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim) for maintenance treatment of chronic obstructive pulmonary disease (COPD), according the agency.

The drug is already available as an inhalation powder — which is not sprayed — called Spiriva HandiHaler. It will remain on the market.

Boehringer Ingelheim stated in a news release that the Respimat form of tiotropium bromide will appear in pharmacies this coming January.

The new version of the drug is indicated for the long-term, once-a-day maintenance treatment of bronchospasm associated with COPD — including chronic bronchitis and emphysema — and to reduce exacerbations in patients with the condition, according to the manufacturer.

Boehringer Ingelheim describes Spiriva Respimat as easier to use than its dry-powder predecessor because it requires minimal inhalation effort by the patient.

"Spiriva Respimat provides a pre-measured amount of medicine in a slow-moving mist that helps the patient inhale the medicine," the company said. "[It] was developed to actively deliver medication in a way that does not depend on how fast air is breathed in from the inhaler."

The FDA based its approval of Spiriva Respimat on 7 clinical trials, including one that compared more than 5700 patients who used the drug with almost 5700 treated with Spiriva HandiHaler.

Sore throat, cough, dry mouth, and sinus infection were the most common adverse events reported by trial participants.

Other bronchodilators made by Boehringer Ingelheim that are delivered with the company's spray technology are ipratropium bromide and albuterol (Combivent Respimat), approved by the FDA in 2011, and olodaterol (Striverdi Respimat), approved just 2 months ago.


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