Sunovion Pharmaceuticals' SUN-101/eFlow New Drug Application (NDA) has been accepted for review by the US Food and Drug Administration (US FDA) to treat patients with chronic obstructive pulmonary disease (COPD).
SUN-101/eFlow (glycopyrrolate) is a nebulised long-term muscarinic antagonist (LAMA), which will be delivered via PARI’s investigational eFlow closed system nebuliser for long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.
The company expects FDA’s action date by 29 May 2017.
SUN-101 is delivered using eFlow nebuliser system developed by PARI Pharma. It is a closed system delivery device that presently being developed for treating moderate to severe COPD.
The new drug application for the product is based on the data collected from clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (Golden) program.
The program included Golden-3 and Golden-4, two-phase 3, 12 week, randomised, double-blind, placebo-controlled, parallel group, multicenter, efficacy and safety trials.
The trial compared SUN-101/eFlow with placebo in adults and the company claims that the drug showed significant change from baseline in trough forced expiratory volume in one second at week 12.
In the case of COPD, the way a medication is delivered would be an important consideration. By combining a proven drug for COPD such as glycopyrrolate with a handheld nebuliser can reduce the time needed for treatment as noted by Pulmonary Research Institute of Southeast Michigan, Dr. Gary Ferguson.
Sunovion executive vice president and chief medical officer Antony Loebel said: “SUN-101/eFlow demonstrates Sunovion’s commitment to delivering innovative therapies for patients with COPD.
“If approved, SUN-101/eFlow would be the first nebulized LAMA for patients with COPD. We look forward to working with the FDA as we seek to gain approval of this innovative drug-device combination and further address the needs of patients with this debilitating condition.”
Sunovion also mentioned that mere acceptance of NDA by the FDa does not mean that it will be approved for the treatment.