Sunovion announces Seebri Neohaler (glycopyrrolate) inhalation powder is now available in the United States.
Sunovion Pharmaceuticals Inc. announced that Seebri Neohaler (glycopyrrolate) Inhalation Powder, 15.6 mcg twice daily, is now available at pharmacies in the United States for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Seebri Neohaler is a long-acting muscarinic antagonist (LAMA).
Sunovion entered into an exclusive license agreement with Novartis for the U.S. commercialization rights to Seebri Neohaler, as well as Utibron Neohaler and Arcapta Neohaler, on December 21, 2016. Novartis received approval from the U.S. Food and Drug Administration (FDA) for Seebri Neohaler in October 2015.
“As a part of our commitment to millions of people living with COPD in the United States, Sunovion is pleased to introduce Seebri Neohaler as a new treatment option,” said David Frawley, Executive Vice President and Chief Commercial Officer at Sunovion. “Seebri Neohaler, a handheld, dry powder inhaler, is an important part of Sunovion’s COPD portfolio that includes a broad range of medications and delivery methods that can address individual patient needs.”
In two multi-center, double-blind, placebo-controlled, parallel group randomized trials, Seebri Neohaler demonstrated statistically significant improvements in change from baseline in lung function over 12 hours (FEV1 AUC 0-12h) compared to placebo (p<0.001).1,2
Improvements in lung function were also measured by forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) within five and 15 minutes post-dose versus placebo on Day 1 and Week 12. Results 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, which is a composite of patient-reported symptoms, activities and impact on daily living.
“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, M.D., 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 health care providers.”
1 L Force, C, Feldman G, Spangenthal, et. al. Efficacy and safety of twice-daily glycopyrrolate in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation: the GEM1 study. International Journal of COPD. 2016:11: 1233-1243.
2 Kerwin E, Siler TM, Korenblat P, et al. Efficacy and safety of twice-daily glycopyrrolate versus placebo in patients with COPD: the GEM2 study. Chronic Obstr Pulm Dis (Miami). 2016; 3(2): In press. doi: http://dx.doi.org/10.15326/jcopdf/3.2.2015.0157
(Source: Business Wire)