Erikka Bergstrom, professor of epidemiology at the University of Cambridge and director of Global Health in the School of Public Health has written a blog post providing a detailed analysis of the likely arrival of lorcaserin, the most likely clinical version of the new NDA for the new ADHD drug named Omnipod developed by Vivus:
The waiting for NDA decisions on this new proposed [lorcaserin/ovipod] is adding to the anxiety and are fears that have already been expressed by some parents, clinicians and industry that this new drug, making its presence in the market much more difficult and less likely to be affordable for many. We are already seeing, more and more mothers taking their children out of school, buying more relevant packages of medications, to get the best therapies for their children.
We should ask ourselves why this drug has been on the market in the USA for twelve years, without having been approved by the FDA. This means that there are many people who have already been taking this drug for years without knowing that it has been withdrawn for safety reasons in Europe. Now that there is a new NDA to be considered, many people feel the anxiety that there could be serious health consequences of over-use.