{"id":15582,"date":"2011-11-01T12:53:46","date_gmt":"2011-11-01T16:53:46","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=15582"},"modified":"2011-11-01T14:57:20","modified_gmt":"2011-11-01T18:57:20","slug":"viibryd-ii","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/11\/01\/viibryd-ii\/","title":{"rendered":"Viibryd II…"},"content":{"rendered":"\n

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Before launching in to the ins and outs of Viibryd<\/font><\/strong>‘s march to market, I thought it would be important to talk about what’s happening out there in my front yard. This weekend, we drove up to Tennessee to a Craft Fair. It was Tennessee [my birth State] at its best. Driving back Sunday on as fine a day as ever was, I was awed as I always am at the beauty of Fall and feeling nostalgic for the Tennessee of my childhood, but when I got home and looked off the steps of my porch, Fall was there too. I expect there’s some lesson in that story, but I’ll pass on figuring it out and move on the the story of Viibryd<\/font><\/strong> and its circuitous route to FDA approval and final release into wide world. <\/p>\n

It’s been a long time coming. This from the FDA Medical Review<\/font><\/strong><\/a><\/u>:<\/div>\n
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The studies in support of this application were conducted under IND 54613. Several meetings were held with the various sponsors over the course of its development. The IND has been held by several different sponsors over its long course. The IND was initially submitted 11-21-97. An early EOP2 meeting was held with the sponsor on 12-20-05, however, this was clearly premature. This meeting focused on a proposed design for the first phase 3 study. Subsequent meetings were held on 8-7-06, 8-20-07, and 5-11-09. The 8-7-06 meeting was another early meeting to discuss CMP, OCP, and pharm\/tox issues. The 8-20-07 meeting was focused on their genetic analysis plan, since at that time the sponsor hoped to utilize biomarkers in their development program. The 5-11-09 meeting was to discuss their second phase 3 study and again their plans for genetic analyses. A preNDA meeting was planned for June, 2009, however, this was cancelled since the sponsor found our preliminary comments sufficient to answer all of their questions. Ultimately, they dropped their plans to include analyses of genetic data as part of this NDA.<\/sup><\/div>\n<\/blockquote>\n

It looks as if it was initially patented by Merck<\/font><\/strong><\/u><\/a> in the mid 1990s:<\/p>\n\n\n\n\n\n
Inventors: <\/font><\/strong><\/td>\n Bottcher; Henning<\/strong> (Darmstadt, DE<\/strong>), Seyfried; Christoph<\/strong> (Seeheim-Jugenheim, DE<\/strong>), Bartoszyk; Gerd<\/strong> (Darmstadt, DE<\/strong>), Greiner; Hartmut<\/strong> (Darmstadt, DE<\/strong>) <\/td>\n<\/tr>\n
Assignee:<\/font><\/strong><\/td>\n Merck Patent Gesellschaft mit beschrankter Haftung<\/strong> (Darmstadt, DE<\/strong>) <\/td>\n<\/tr>\n
Appl. No.: <\/font><\/strong><\/td>\n 08\/314,734<\/strong><\/td>\n<\/tr>\n
Filed: <\/font><\/strong><\/td>\n September 29, 1994<\/strong><\/td>\n<\/tr>\n<\/table>\n

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So then Merck<\/font><\/strong> did a few Clinical Trials, and somewhere along the line, GSK<\/font><\/strong> picked it up and did three Clinical Trials. What’s interesting is that those early trials were all busts<\/font><\/strong><\/u><\/a> involving almost 2000 subjects, some 60% of them taking Vilasodone [they couldn’t even make Prozac and Celexa work in those trials!]. The licensing returned to Merck in 2003 after these disappointing studies. But then<\/font><\/strong><\/u><\/a>:<\/div>\n