Acadia and the FDA

In the upcoming May issue of NeuroPerspective, we will be including some commentary about institutional and regulatory rituals which endure without clear justification–or at the very least,  deserve some reconsideration. This comes in the wake of having recently had the opportunity to spend a couple of days  talking at great length with a former high-profile FDA regulator, where both his intelligence, integrity, and humane desire to do the right thing, and a narrow view of what constitutes the avenues to doing so, were quite salient. Now, the FDA is hardly the only repository of such rituals, indeed no entity epitomizes anachronisms-in-action, or inaction,  more definitively  than the US Congress, but the FDA is of particular relevance to what we do here, so its reliance upon familiar rituals and criteria is highly figural.

But even as we note a history of inflexibility, today some credit looks to be due as well: The FDA has informed Acadia Pharmaceuticals that the single Phase III trial conducted for pimavanserin in Parkinsonian psychosis is sufficient for NDA submission. This is forward-looking and entirely appropriate in its exercise of flexibility: the data are clearcut, and this is a treatment that addresses a need otherwise unmet, at least with any semblance of clinical satisfaction and safety. While it has been noted  that this does not guarantee approval,  unless some unforeseen issue crops up safety-wise, and the likelihood of that, given pimavanserin’s extensive human database, is minimal–the invitation to file infers the strong likelihood of approval, on the basis of the data as it stands. Good for the FDA, good for Acadia Pharmaceuticals, and good for Parkinson’s patients. Win-win-win. We have not had the opportunity to say that often, if ever.

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One Response to Acadia and the FDA

  1. “The FDA has informed Acadia Pharmaceuticals that the single Phase III trial conducted for pimavanserin in Parkinsonian psychosis is sufficient for NDA submission.”

    I cannot recall the FDA doing this before with a psych drug. Took me by complete surprise considering the N was only 200 and lasted just 6 weeks. Curious if you know of any other psych drugs that were approved with just a single P3 trial? My guess is Pima’s open label trial must look very good. That data gets reported for the 1st time at an Australian conf next week.
    http://www.mdscongress2013.org/UserFiles/file/2013-final-program.pdf

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