Sabril is a very effective anti-epileptic drug that won approval in the US only in August 2009 after a tortured application process. It is indicated for the treatment of infantile spasms and adults with who have run out of treatment options. The reason for such a limited label is the drug’s very serious side-effect; up to 40% of patients may lose some or nearly all of their vision. What a trade-off to be seizure free!
Matthew Herper of Forbes gives a good background of the drug’s path to market here.
But there is reason for hope. A small biotech called Catalyst is working on a follow-up compound to Sabril that may have its efficacy without the ocular effects. It is only in Phase I and even if successful, won’t make it to market for years. But the compound, CPP-115, appears to be one of the more promising drugs in the thin epilepsy pipeline.
CPP-155, may the FDA look kindly upon you.