To: Nick who wrote (778 ) 3/28/1998 10:01:00 PM From: Zebra 365 Read Replies (1) | Respond to of 9523
Congratulations to all on the PFE thread!! For the doc's out there, or anyone else, this link takes you to where you can download the Viagra package insert in PDF (Adobe Acrobat) format. It is the "Final Approved Labeling Text" file. Has summaries of the major studies in there. fda.gov But just when you think you've got the only PDE V inhibitor on the planet....... ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ICOS Announces Initiation of Overseas Phase 2 Trial With IC351 BOTHELL, Wash.--(BUSINESS WIRE)--Jan. 13, 1998 --ICOS Corporation (NASDAQ:ICOS - news) announced today the initiation of a Phase 2 clinical trial with IC351 in patients with male erectile dysfunction (MED). This randomized placebo-controlled, crossover study is being performed overseas. The Phase 2 clinical trial includes patients with mild to moderate MED. The study is designed to assess the safety and physiological effects of IC351 in this patient population. Approximately 20-30 million men in the United States are estimated to suffer from some degree of MED. This condition, sometimes referred to as impotence, can be a consequence of several factors, among them cardiovascular insufficiency. IC351 is a selective PDE5 phosphodiesterase inhibitor that is thought to reinforce the normal physiological signals to increase blood flow. Such an increase in blood flow is an integral part of the erectile response. The Company's goal is to demonstrate that IC351 is a useful treatment for MED and cardiovascular disorders. ICOS is discovering and developing new pharmaceuticals by seeking points of intervention in the inflammatory process that may lead to specific and efficacious drugs. ICOS' research and drug development programs involve both acute and chronic conditions such as ARDS, acute pancreatitis, asthma, hemorrhagic shock, male erectile dysfunction, multiple sclerosis, myocardial infarction, and psoriasis. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ No where near a New Drug Application but, every sucessful drug can be reengineered around the patent, look for a "Me-Too" PDE V drug in the future. Happy Investing! Zebra