Sunovion has submitted a new drug application to the FDA for its SUN-101/eFlow glycopyrrolate for the treatment of COPD, the company said. The company recently reported positive results from the GOLDEN-5 long-term safety study of SUN-101/eFlow and had previously reported data from the GOLDEN-3 and GOLDEN-4 efficacy trials that are being used to support the NDA.
The product includes a version of PARI’s eFlow rapid nebulizer system optimized to deliver the SUN-101 glycopyrrolate inhalation solution, according to the company.
Sunovion Executive VP and Chief Medical Officer Antony Loebel commented, “Patients are at the heart of everything we do at Sunovion. This is an important milestone for us and the larger respiratory community, as we continue our mission of pioneering innovative treatments and therapies for COPD patients, their caregivers and healthcare providers.”
Read the Sunovion press release.
