Sunovion Pharmaceuticals has received a complete response letter from the U.S. Food and Drug Administration (FDA), clearing the Massachusetts company from having to conduct further clinical trials for approval of its SUN-101/eFlow (glycopyrrolate) therapy to treat chronic obstructive pulmonary disease (COPD).
According to a corporate press release, the CRL clears Sunovion from conducting additional clinical trials for the approval of SUN-101/eFlow.
SUN-101’s key ingredient is glycopyrrolate, a long-acting muscarinic antagonist (LAMA) bronchodilator that binds to the muscarinic receptor subtypes M1 to M5. SUN-101 is delivered via the proprietary investigational , handheld eFlow closed system nebulizer.
The FDA’s complete response letter answers Sunovion’s August 2016 request, when it submitted a new drug application to the FDA. That filing was based on data from the GOLDEN clinical program, which included seven studies in total. However, for this filing, only three randomized Phase 3 clinical trials were considered: GOLDEN 3 (NCT02347761), GOLDEN 4 (NCT02347774), and GOLDEN 5 (NCT02276222), which evaluated the SUN-101/eFlow system’s efficacy and safety.
Results from these Phase 3 studies were encouraging, according to data presented at last month’s American Thoracic Society 2017 International Conference in Washington. Both the GOLDEN 3 and GOLDEN 4 trials met their primary endpoints, finding statistically meaningful changes from baseline in forced expiratory volume (FEV1; a measure of lung function) compared to placebo. Treatment was found to be well tolerated, with no major adverse effects reported.
The GOLDEN 5 trial was a 48-week, open-label safety study and determined that SUN-101/eFlow was well tolerated as a twice-daily maintenance therapy for bronchoconstriction, with a similar overall incidence of adverse events to standard of care. In this trial, the incidence of major adverse cardiovascular events was comparable to that of Spiriva (tiotropium).
SUN-101/eFlow is under “registration” status in Sunovion’s pipeline, and is expected to win approval soon. Sunovion is working with the FDA to chart its next steps. If approved, the candidate would be the first U.S. nebulized LAMA treatment cleared for long-term maintenance of airflow obstruction in COPD.