New Drug Application for Sunovion’s COPD Therapy Accepted by FDA

The FDA recently accepted a New Drug Application (NDA) for Sunovion’s investigational treatment SUN-101 (glycopyrrolate) administered by the eFlow nebulizer to treat adults with chronic obstructive pulmonary disease (COPD).

Although the FDA’s acceptance of the NDA for review does not guarantee approval, it is a crucial step in the drug approval process. Sunovian filed the NDA in July.

SUN-101 is a long-acting blocker of muscarinic receptors intended for COPD maintance. The eFlow nebulizer was developed by PARI Pharma, which collaborated with Sunovion to bring SUN-101 to the market.

“SUN-101/eFlow demonstrates Sunovion’s commitment to delivering innovative therapies for patients with COPD,” Dr. Antony Loebel, MD, Sunovion’s executive vice president and chief medical officer, said in a news release. “If approved, SUN-101/eFlow would be the first nebulized LAMA [long-acting muscarinic antagonist] for patients with COPD.”

The FDA accepted the NDA application based on data from the GOLDEN clinical trials program. The GOLDEN-3 (NCT02347761) and GOLDEN-4 (NCT02347774) Phase 3 studies both explored the effects of SUN-101/eFlow treatment compared to a placebo for 12 weeks in patients with moderate to very severe COPD.

Both trials resulted in improved lung function compared to a placebo. Lung function was measured by forced expiratory volume in one second (FEV1).

The open-label Phase 3 GOLDEN-5 (NCT02276222) trial continued exploring the safety and tolerability of the treatment over 48 weeks. The study included 1,087 patients in a direct comparison to the drug Spiriva (tiotropium bromide) delivered once-daily by the HandiHaler nebulizer.

“The way a medication for COPD is delivered is an important consideration,” said Dr. Gary Ferguson of the Pulmonary Research Institute of Southeast Michigan. “By combining glycopyrrolate, a proven therapeutic option for COPD, with an advanced, handheld nebulizer delivery system designed to reduce the amount of time required for a treatment, SUN-101/eFlow has the potential to be a valuable alternative therapeutic option for patients who suffer from COPD.”