Theravance Biopharma Inc and Mylan NV have initiated a Phase 3 program for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) in development for the treatment of COPD.

The Phase 3 program, designed to support the registration of the product in the US, includes two replicate three-month efficacy studies and a single 12-month safety study.

“Despite the fact that once-daily LAMAs are the first-line therapy for patients with moderate-to-severe COPD, there still are no nebulized LAMA treatments available today,” said Brett Haumann, MD, Senior Vice President, Clinical Development at Theravance Biopharma. “This unmet need is significant when one considers that approximately 9% of COPD patients in the US currently use nebulizers for ongoing maintenance therapy, and a total of 41% of US COPD patients use nebulizers for bronchodilator therapyat some time during the course of their disease.”