A “White Whale” — Now Disappearing — Over The Still-Luminous Horizon?

More than a few usually-reserved journalists have referred — over the last few days — to suvorexant’s potential to be an insomnia agent with a “clean” morning wake-up (no impairment, or grogginess) as the “great white whale” many a pharma-captain has long roamed the oceans, hunting, just as we all remember, Ahab did.

Me? i’m not so sure. . . .

Based on the newly-public, more detailed looks at the study data Merck submitted to support FDA approval of suvorexant, several FDA staffers are now apparently concerned that — as is true of all agents now on the market (including many cheap generics) — a 40 mg dose of suvorexant will be associated with some non-trivial morning after impairment.

And so — when you read of stock analaysts boldly predicting north of $500 million in peak annual sales for this drug — they are doing so on the assumption that it is the legendary white whale: a drug that lets you sleep, but doesn’t leave you foggy, in the morning.

After hearing Merck’s own science staff suggest that suvorexant is likely “not very effective” at improving sleep, at the 10 mg dose which these FDA staffers felt would be “safest” (for driving, on the morning after), I simply cannot shake the notion that this agent — while first in its brand new class — is going to be much more of a “me too” product. A me too — fighting it out with the generics — at perhaps ten times the cost.

So, now it is up to FDA: does Merck get approval for a sleep maintenence indication, at the higher doses (30/40 mg)?

And, if so, will FDA slap lots of tough label restrictions, onto to the bottle/into the insert? That is, will the label read like all the others now on market: “don’t drive the morning after taking,” etc.? [If so, why not take the cheaper generic?]

If, on the other hand, FDA grants approval on the 10 mg dose only, and thus sends a signal that “safety” here is far more important than being sure to sleep through the night (go low and slow, at first) — will doctors write off-label, in double (or higher) doses? And even if they don’t — what to make of patients who decide to double dose, on their own, when they cannot sleep?

All of these vagaries lead me to the strong hunch that suvorexant’s approval — which will happen in 2013 — will only be moderately good news for Whitehouse Station. I remain convinced that it will peak at under $200 million in annual sales — in 2017 or so, based on the signals buried in the study data, seen yesterday.

And so, Ahab’sgreat white whale” has likely crested the horizon, showing its tail to us, yet again. At least that’s my guess. What’s yours?

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