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The clinical trial should give Arena a clear sense of how well the drug is working. The study enrolled 744 patients, with one-third getting a low dose, one-third a higher dose, and the rest on a placebo, Lief says. The main goal will be to see whether the medicine can help people reduce the number of times they wake up during the night. Secondary goals—which are more subjective and difficult to accurately measure—will look at whether patients had higher-quality sleep, whether they slept a longer time, whether they fell asleep faster, and spent less time awake between sleeping bouts.
Safety, as with any drug with potential to be taken by millions of people, has to be squeaky clean to satisfy the FDA. Based on trials to date, Lief says he’s confident that’s not a problem. “You can swallow a whole bottle of this and it won’t cause you harm,” he says.
If Arena can show this drug is effective at helping people sleep better, it hopes that Wall Street will wake up. Arena stock, like that of many unprofitable biotechs, has taken a beating this year, falling by more than 56 percent. “Investors only care about obesity, they only give us credit for our lead compound,” Lief says. “This is actually really an exciting time for the sleep community.”
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