Brisbane, Australia and Delaware, United States, 4 April 2016: Australian drug development company Invion Limited (ASX:IVX) is pleased to advise that it has met with the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) of the US Food and Drug Administration (FDA) to discuss Phase 3 plans for development of oral nadolol as a treatment for patients with COPD who cannot quit cigarette smoking.
Written and oral communication fully supports Invion’s proposals for further manufacturing in conjunction with Phase 3 development. In addition, the FDA confirmed that the animal toxicology package is complete. The Company and the FDA engaged in a highly productive dialogue on the design and regulatory target of the Phase 3 plan for oral INV102. In meeting directly with senior FDA officials, Invion team members were able to explain the role that airway healing can play in enabling these patients to quit, by reducing cough and phlegm. Invion was able to place the smoking cessation program into the context of treating COPD.
Executive Vice President R&D and Chief Medical Officer, Dr Mitchell Glass said, “We are pleased that the FDA has confirmed our plans for INV102 as a treatment for patients with established chronic bronchitis who cannot quit smoking due to increased cough and sputum production.
“Our discussion, based on their in-depth review, reflected their deep interest in our program and their shared desire to see us succeed in enabling these patients to quit by ameliorating symptoms that have precluded previous quit attempts.
“We welcome their recommendations, which will focus and strengthen our registration program without causing delay.”
FOR MORE INFORMATION CONTACT Dr Greg Collier. P: 07 3295 0500 firstname.lastname@example.org