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Sunovion announces results of long-term safety study of glycopyrrolate inhalation solution

Sunovion has announced results from the Phase 3 GOLDEN-5 48-week safety study of SUN-101 glycopyrrolate inhalation solution in patients with moderate-to-very severe COPD. According to the company, the data show that SUN-101 was well tolerated, and the incidence of adverse events was similar to that of the active comparator, Spiriva Handihaler. The study enrolled 1,087 patients who received either twice-daily SUN-101 delivered by the PARI eFlow nebulizer system or once-daily Spiriva Handihaler.

Earlier this year, Sunovion announced positive results from the GOLDEN-3 and GOLDEN-4 Phase 3 efficacy trials.

Sunovion Executive VP and Chief Medical Officer Antony Loebel commented, “Sunovion has a longstanding history of advancing treatment options for patients with COPD. The results from the GOLDEN-5 study further build on the strong safety and efficacy profile we have seen in our previous Phase 3 studies, and we look forward to advancing SUN-101/eFlow through the regulatory process as the first nebulized LAMA for patient use.”

Read the Sunovion press release.

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published on July 22, 2016

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