U.S. FDA declines to approve Alkermes' schizophrenia treatment

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I think some researchers are considering that people wear small hollow plastic tubes up their nostrils while eating as a potential treatment for obesity. The tubes cover the smell receptors in the nose and temporarily lessen the sense of taste. Sounds plausible.

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Following a remote review of manufacturing records, the FDA stated that resolution of certain conditions related to the tablet coating process at the company’s facility was required before the treatment can be approved.

That’s it? the coating process?

The drug is a combination of olanzapine, the active ingredient of Eli Lilly’s Zyprexa, with samidorphan, an opioid antagonist designed to counter the weight gain and metabolic side effects of Lilly’s antipsychotic.

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Do you think they will approve it easily if the company betters the coating process?
I’m on olanzapine and mostly my only side effect is weight gain. This would be a good med for me

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I haven’t followed this one closely, but I expect so. The company says it’s already fixed the issue, that it occured early on in the process and was fixed before the FDA application. I guess the FDA just wants them to prove it.

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