NDA Accepted for Nebulized Long-Acting Muscarinic Antagonist for COPD

The LAMA will be delivered via the investigational eFlow nebulizer
The LAMA will be delivered via the investigational eFlow nebulizer

Sunovion announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for SUN-101 (glycopyrrolate) delivered via the investigational eFlow closed system nebulizer, for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)

Glycopyrrolate is a nebulized long-acting muscarinic antagonist (LAMA). If approved, SUN-101/eFlow would be the first nebulized LAMA drug for patients with COPD. The proprietary eFlow nebulizer system by PARI Pharma is a unique closed system delivery device under development for moderate-to-very severe COPD.  

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The NDA was based on data from the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) clinical trials program that included two Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials (GOLDEN-3 and GOLDEN-4) comparing SUN-101/eFlow vs. placebo. The studies, which included adults with moderate-to-very severe COPD, met their primary endpoints, demonstrating that patients treated with SUN-101/eFlow had a statistically significant change from baseline in trough forced expiratory volume in one second (FEV1) at Week 12 vs. placebo.

GOLDEN-5 was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial that evaluated the long-term safety and tolerability of SUN-101/eFlow in adults with moderate-to-very severe COPD; an active comparator Spiriva Handihaler (tiotropium bromide; Boehringer Ingelheim) was included. 

The expected action date under the Prescription Drug User Fee Act (PDUFA) is May 29, 2017.

For more information call (800) 739-0565 or visit Sunovion.com.

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