Seebri Neohaler, a handheld, dry powder maintenance treatment of airflow obstruction in people with COPD, is now available for prescription in the US, according to Sunovion.
Sunovion entered into a license agreement with Novartis for the US commercialization rights to Seebri Neohaler on December 21, 2016. Novartis received approval from the US Food and Drug Administration (FDA) for Seebri Neohaler in October 2015.
In two multicenter, double-blind, placebo-controlled, parallel group randomized trials, Seebri Neohaler demonstrated statistically significant improvements in change from baseline in lung function over 12 hours compared to placebo, according to Sunovion.
Results also showed reduced use of rescue medication and improvements in health-related quality of life, as measured by the St George’s Respiratory Questionnaire (SGRQ) total score.
“COPD is a serious, progressive respiratory disease that should have a personalized approach to choosing a therapy and delivery method, and there remains a need for additional treatment options for newly diagnosed patients as well as those managing uncontrolled symptoms,” said Edward Kerwin, MD, Medical Director of the Clinical Research Institute of Southern Oregon. “Seebri Neohaler is a long-acting muscarinic antagonist delivered through a small, handheld inhaler that provides important audiovisual feedback to patients, caregivers and healthcare providers.”
More information is available on the Seebri Neohaler website.