The antipsychotic drug Fanapta (iloperidone) may never make it to pharmacy shelves. The FDA recently deniedVanda Pharmaceuticals' request to approve the drug, saying more clinical and safety data are needed. Vanda had already begun preliminary marketing of the drug, with teaser ads appearing in
Psychiatric Services. Fanapta is Vanda's lead drug. A
story at TheStreet.com notes that the company's CEO says it does not currently have the capital available to conduct the studies the FDA needs to reconsider the drug. With Vanda's stock now trading at around $1 (down from a 52-week high of $19), one has to wonder if this is the finale for Fanapta. It certainly has been a rocky road for iloperidone, which
Novartis dropped in 2001 because of market conditions and concerns about the drug's possible effect on the electrical impulses of the heartbeat. A special thanks to John M. Hawkins at the
Lindner Center of HOPE in Mason, Ohio, for alerting us to the FDA's action. More details on the Lindner Center, opening in just a few days, will be in our September issue.