Monday, May 20, 2013

Suvorexant Update: Still On Track For 2013 FDA Approval, Sales Uncertain In Crowded, Genericized Sleep Space

The good news here is that nothing untoward has turned up in this morning's FDA reviewer/staff packet, in advance of Wednesday's FDA Advisory Committee meeting.

The candidate is still on track. However, the pitch has always been that suvorexant's appeal would lie in its "next morning clarity" -- that is, it would not be associated with impairment in the morning after being taken -- as so many previously FDA approved sleep aids are, on market.

The FDA reviewers are now noting some morning after impairment -- and talking about lower initial dosings -- all in a space full of generic competitors. That makes the sales outlook a little cloudy. A bit from Reuters, then -- do go read it all:
. . . .Merck's experimental insomnia drug suvorexant appears generally effective, according to reviewers at the U.S. Food and Drug Administration, but they questioned the company's proposed dosing levels.

The reviewers posted their comments on the FDA's website on Monday, two days ahead of a meeting of outside medical experts which will advise the agency on whether or not it should approve the drug. . . .
We will of course keep you posted on Wednesday afternoon, but I expect a solid majority vote, in favor of US FDA approvability.

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