Sunovion Pharmaceuticals has announced receipt of a Complete Response Letter (CRL) from the FDA in regards to their New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate), a drug developed for the maintenance of chronic obstructive pulmonary disease (COPD). According to the biopharmaceutical company, the approval rejection letter did not stipulate the company conduct any further trials of the drug.
The NDA for the long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the investigational eFlow nebulizer was submitted to the regulator in July of 2016. Because the FDA’s rejection likely did not relate to safety and efficacy issues, it’s unclear what prevented the approval.
“Sunovion will work with the FDA to determine an appropriate path forward,” said the press release. “We are confident in SUN-101/eFlow and are committed to bringing this innovative therapy to COPD patients in the US as quickly as possible.”
COPD affects around 15.7 million adults in the US, however, millions more are believed to have undiagnosed chronic bronchitis and emphysema. Symptoms of COPD – including coughing, wheezing and shortness of breath – worsen over time, contributing to over 120,000 deaths in the US each year. The incidence of COPD is also on the rise in China due to high levels of air pollution and prevalence of smoking among adults.
Glycopyrrolate is currently approved to reduce throat and airway secretions, usually administered before a patient undergoes a surgical procedure. The company’s investigational closed eFlow nebulizer system was designed for optimal delivery of SUN-101 to reduce airflow obstruction in patients with COPD.
Two Phase III clinical trials – GOLDEN-3 and GOLDEN-4 – were conducted to assess the safety and efficacy of SUN-101/eFlow compared to the placebo in adult patients with moderate-to-very severe COPD. A third Phase III clinical trial – GOLDEN-5 – was an open-label study designed to test the long-term safety and tolerability of the combined product.
The three late-stage clinical trials enrolled nearly 2,400 patients in total, and Sunovion reported that the treatment was well-tolerated. GOLDEN-3 and GOLDEN-4 found that patients treated with SUN-101/eFlow showed statistically significant improvements in pulmonary function compared to the placebo.
“COPD symptoms can severely impact patients’ daily activities and health-related quality of life, and it is important for any treatment to be not only well-tolerated and effective but also easy to administer,” Dr. Gary Ferguson, Pulmonary Research Institute of Southeast Michigan and Principal Investigator for the GOLDEN-5 clinical trial said when the results of the trials were released. “With its efficacy and tolerability profile as well as the portability and short administration time, SUN-101/eFlow could be a valuable treatment option for patients with COPD.”
The COPD market in the US and China is expected to reach a value of $18.7 billion by 2024, according to Transparency Market Research. Major players in the market currently include AstraZeneca, Boehringer Ingelheim and Novartis.