FDA Wants Additional Information on Indiplon
Looks like Neurocrine will continue with its development of Indiplon based on recent news.
Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA
Seems the FDA wasn’t happy with the pharmacokintetic/food effect profile provided in the application. The FDA it seems would like to see additional meal profiles to see what effect various meals may have on the distribution of Indiplon in the body. The press release states that Neuocrine will have a meeting with the FDA in October of this year for further clarification. If indeed this is the only sticking point, then it should be relatively easy for Neurocrine to perform additional studies to resolve this issue.
It would be interesting to know what the nature of the problem was. My guess (and it is only a guess) is that Neurocrine may have looked at food consumed hours before taking the drug and not at taking the drug in conjunction with food just before going to bed. Also, some people with insomnia tend to eat fairly large meals right before attempting to go to sleep and this may contribute to problems with the drug’s half-life. Remember, one of the claims for Indiplon is that it lasts longer than others on the market and this may also be why the larger dose was not approvable whereas the lower dose levels were approval (if further work was done).
Technorati Tags: Indiplon, Neurocrine, sleeping pill
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