FDA Agrees to New Review of the SUN-101/e-Flow COPD Treatment System

U.S. regulators have agreed to Sunovion Pharmaceuticals’ request for another review of its SUN-101/e-Flow system for treating chronic obstructive pulmonary disease.

The review will cover a New Drug Application that Sunovion resubmitted after the Federal Drug Administration decided the company did not have to conduct additional clinical trials of SUN-101/e-Flow’s safety and effectiveness. The application deals with the system’s use as a long-term maintenance treatment for COPD airflow obstruction.

SUN-101/e-Flow consists of a therapy and a device that delivers it as a mist.

Sunovion developed SUN-101/eFlow as a nebulized — or mist-formulated — treatment for moderate to severe COPD. SUN-101 is a long-acting muscarinic antagonist bronchodilator, or substance that widens airflow passages so the lungs can get more oxygen. PARI Pharma developed the proprietary eFlow nebulizer.

Results of Sunovion’s GOLDEN clinical trials supported the resubmitted applications. GOLDEN stands for Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer.

The GOLDEN series included three Phase 3 trials: GOLDEN-3 (NCT02347761), GOLDEN-4 (NCT02347774), and GOLDEN-5 (NCT02276222). All assessed the safety and effectiveness of the SUN-101/eFlow system.

Sunovion’s system significantly improved a measure of COPD patients’ lung function called forced expiratory volume, or FEV1, compared with patients who received a placebo.

Patients also tolerated it well. The number of adverse events was similar to that of standard therapies, the team said.

“We look forward to working with the FDA during their review of the SUN-101/eFlow resubmission, which, if approved, would be the first nebulized LAMA for patients with COPD in the United States,” Dr. Antony Loebel, executive vice president of Sunovion, said in a press release.

“Building on the strength of our heritage in nebulized treatment for COPD, the development of this innovative drug-device combination underscores our commitment to ensuring patients have choices in medication and delivery options with the goals of individualizing and optimizing treatment,” Loebel added.

Sunovion submitted its first New Drug Application to the FDA in July 2016. The agency accepted the application in October.

In April of 2017 it asked that Sunovion supply more information in the application. Then, in May of 2017, it sent Sunovion a Complete Response Letter saying that no additional trials would be necessary before Sunovion resubmitted its application.

The FDA is expected to make a final decision on the new application by December 15, 2017.