Why Is Actelion Suppressing Phase III Data?

I highly recommend a terrific article by Ian Parker in this week’s New Yorker about Merck’s efforts to develop a novel insomnia drug, suvorexant. Normally I don’t write about non-cardiology topics but I want here to call attention to one small, almost tangential detail buried in the middle of the story. It’s not about the Merck drug but about another orexin antagonist from Actelion, almorexant:

“At the time, Jed Black, the Stanford sleep specialist, was on a two-year leave of absence, working full time on almorexant, the rival drug made by Actelion. Phase III trials of the drug were under way. This work has not been published, and Black cannot discuss it, although he recently described almorexant as having ‘an absolutely remarkable profile’ that was likely to outperform zolpidem in sleep maintenance.

But, in early 2011, Actelion announced that it was halting the drug’s development, because of an undisclosed possible safety issue. Merck’s scientists speculated about the nature of the concerns, and feared for the future of suvorexant. Black said that the problem was ‘straightforward,’ but that Actelion had decided to pause and take its time. ‘I don’t think almorexant needs re-tinkering at the molecular level,’ he said, implying a problem of drug delivery. Black, who is back at Stanford, suspects that almorexant will be launched, and is certain that such drugs will eventually become dominant. (GlaxoSmithKline recently published results, from Phase II studies, of its own orexin antagonist.)”

The time frame is not entirely clear, but it appears that Actelion has been actively suppressing phase III data about almorexant for several years at least.

Click here to read the full post on Forbes.

 

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Comments

  1. Are you sure Actelion are suppressing their phase III results? If they are, they’re really not doing a very good job of it, because the results have been posted on clinicaltrials.gov

    See here:

    http://clinicaltrials.gov/ct2/show/results/NCT00608985?term=almorexant&rank=1

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