Clinical development of drugs for epilepsy: a review of approaches in the United States and Europe.

The process of drug development of new anti-seizure drugs is addressed, with an emphasis on the differences between the United States and Europe. The article begins with a brief description of the companies that are responsible, in partnership with academia and clinicians, of bringing drugs to the marketplace. In considering the differences in drug development between the US and EU, it is not so much the companies that drive the differences but the regulatory processes. In fact, the only major principle on which the US and EU regulatory processes differ is on the path to monotherapy approval. The drug development process might seem to some to be a simple exercise in uncovering whether a drug is effective against a disease or a disorder and simultaneously evaluating its safety for the targeted patient population. While these issues are paramount in the minds of all involved, regulation of the industry has become extraordinarily sophisticated and complex. Most of the actions taken by a company are, at least in part, driven by the government administrations charged with drug development oversight. The similarities of the US and EU drug development processes are great; however, sufficient differences mandate close attention to obtain registration on both sides of the Atlantic.