Whitehouse Station just announced a few minutes ago that it had received a “complete response” letter from FDA on sleep drug candidate suvorexant. [Our backgrounder is here; the May FDA Advisory Meeting recap is here.]
The upshot — given that manufacturing studies are needed for the 10 mg dose, and controlled-substance clearance is still required — is that it will be very late in 2013 (or Q1 2014) before suvorexant is approved in the US.
In addition, given that FDA staff is suggesting that the candidate take the “low and slow” dosing stair-stepping approach — I’d expect slower revenue ramps for the drug, than might have been expected, had the higher dosings been listed as approvable, from the go. Even so, it might be a half-billion dollar drug in the US by late 2018.
Here is a bit of the presser:
. . . .Based on initial review of the letter, Merck has determined that additional clinical studies of suvorexant 10 mg will not be necessary. However, manufacturing studies will be required to advance the 10 mg dosage form. Merck will discuss with the FDA whether additional studies will be required to support the 5 mg dose.
As previously disclosed, both FDA approval and a separate scheduling determination by the U.S. Drug Enforcement Administration are required before Merck can introduce suvorexant in the United States. . . .
As ever, we will keep you informed. And, fascinatingly, as if someone had been given wind of the FDA letter, there were three or four larger national law firm-generated Google searches — of my site, on Friday afternoon and night — specifically looking to see if suvorexant had been given a green light at FDA, as of month’s end. Well, here’s your answer, ladies and gentlemen: not just yet.
[Helpful hint — to those lawyers: you all should really think about encrypting your search requests, on matters like this. I’d never disclose it early, but it did give me a strong sense that Merck’s firms expected some action before July 1. As I say, fascinating.] So it goes.