Monday, December 2, 2013

Suvorexant's Latest FDA Sojourn -- Told As A Novella -- To The New Yorker

Over the long holiday weekend, The New Yorker has a great story on its hands (however, the story appears in the coming weekend print edition). And Ian Parker takes the full eleven pages to tell it -- this is the story of suvorexant's latest journey through the FDA -- and the ways in which at least some very eager pharmaceutical company scientists perceive the role(s) of FDA. It is well-told, and for anyone who likes "history of science" stories, this is a page turner. Do give it a go.

I'll not give away the punch-line here, but I do think the scientists have a solid point. And I do see the FDA's concern: sleep medicines ought not leave the patient as impaired as a drunk driver, on the morning after, especially when we know that the vast majority of those patients will go get behind the wheel in the morning, to drive to work -- or to run errands. It is certainly a complicated dance to orchestrate. How much is enough? And how much. . . is too much? [Really -- do go read it -- but here's a bit of our background on the candidate (we now expect it will be mid-2014 or later before any real movement on approval will occur in the US). And, here's a bit more of it.]

From the feature, then -- which includes a pretty solid rundown of the history of sleep medicines, as well -- a bit:

. . . .If the Merck scientists succeeded at the F.D.A., they would be the first to bring an orexin-related drug to market. “It’s an amazing achievement,” Richard Hargreaves, the fourth colleague at the Hilton, said. “Everyone should be really proud.” But, he added, “my worry is that a new mechanism is being evaluated on the science of an old mechanism.”

“With Ambien, you’ve got a drug that’s got basically only onset,” Renger said, dismissively. That is, it sends you to sleep but might not keep you asleep. “Suvorexant has the onset, but it has the great maintenance, especially in the last third of the night, where other drugs fail.” And even though suvorexant keeps working longer than Ambien, suvorexant patients don’t feel groggier afterward, as you might expect. Impassioned, Renger imagined himself addressing the F.D.A.: “Why aren’t you giving this a chance?

. . . .The F.D.A.’s decision left Merck facing an unusual challenge. In the Phase II trial, this dose of suvorexant had helped to turn off the orexin system in the brains of insomniacs, and it had extended sleep, but its impact didn’t register with users. It worked, but who would notice? Still, suvorexant had a good story — the brain was being targeted in a genuinely innovative way — and pharmaceutical companies are very skilled at selling stories.

Merck has told investors that it intends to seek approval for the new doses next year. I recently asked John Renger how everyday insomniacs would respond to ten milligrams of suvorexant. He responded, “This is a great question.” After the approval process is finished, the marketing division of Merck — a company whose worldwide sales last year totalled forty-seven billion dollars — will conduct a different kind of public trial. The study will address this question: How successfully can a pharmaceutical giant — through advertising and sales visits to doctors’ offices — sell a drug at a dose that has been repeatedly described as ineffective by the scientists who developed it?

A great question, indeed. Do stay tuned.

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