Promising Results in Phase 3 Trials for Nebulized Glycopyrrolate in COPD

Over 1,200 people took part in the two Phase 3 trials
Over 1,200 people took part in the two Phase 3 trials

Sunovion Pharmaceuticals announced positive data from its Phase 3 study of SUN-101 (glycopyrrolate), to treat people with moderate-to-very severe chronic obstructive pulmonary disease (COPD). SUN-101 is a nebulized long-acting muscarinic antagonist (LAMA) which is delivered using the ‘eFlow nebulizer system', manufactured by respiratory company, PARI.

The Phase 3 study (GOLDEN-3 and GOLDEN-4) was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial which lasted for 12-weeks. Each trial consisted of 653 and 641 people, respectively, who were randomized to SUN-101/eFlow 50mcg, SUN-101/eFlow 25mcg or placebo, twice daily.

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Study results met the primary endpoints in both 50mcg and 25mcg groups, which was statistically significant change from baseline in trough forced expiratory volume in 1 second (FEV1) at week 12 versus placebo. In addition the SUN-101/eFlow was well-tolerated as a twice-daily treatment of bronchoconstriction in patients with COPD.

Data from the Phase 3 trials will support a forthcoming NDA for SUN-101/eFlow, which the company expects to submit within the fiscal year.

For more information visit Sunovion.com or PARI.com.

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