The end of the first quarter is just a few weeks away and more than a few biotechs still haven’t delivered the important clinical trial results they told investors to expect before the end of the period. The clock’s ticking for Axsome Therapeutics (NASDAQ:AXSM), Galapagos(NASDAQ:GLPG) and their experimental treatments.
Here’s why investors are so eager to get their hands on their trial readouts.
Axsome Therapeutics: Hooray for cough syrup?
Physicians have been treating depression with bupropion, the active component in Wellbutrin, since the 1980s, and it could get an unexpected costar in 2019. Physicians and pharmacists generally issue stern warnings not to mix the common cough suppressant dextromethorphan with bupropion, but Axsome is testing a fixed combination of the pair called AXS-05.
You’re not supposed to mix the drugs that are in AXS-05 because they amplify each other’s effects. Axsome is testing its fixed-dose combination as a treatment for major depressive disorder (MDD) that resists other drugs. AXS-05 is in a pivotal trial right now, and it looks like the combination has longer legs than anyone expected.
Axsome blew everyone away in January with mid-stage trial data that suggest AXS-05 really does the trick. After six weeks, 47% of patients treated with AXS-05 achieved clinical remission compared to just 16% of the placebo group.
Cough medicine isn’t the only surprising antidepressant booster. The FDA recently approved Spravato, Johnson & Johnson‘s (NYSE:JNJ) brand of ketamine nasal spray, to be used along with standard oral antidepressants such as Cymbalta or Zoloft.
Patients who want to use Spravato need to see a healthcare professional, who will squirt the popular party drug from the 1990s up the patient’s nose and observe them for at least two hours before letting them drive. Despite ketamine’s drawbacks, J&J thinks it can eventually deliver $1 billion in annual sales at its peak.
Around 6.7% of all U.S. adults suffer a major depressive episode each year, and around a third of patients don’t respond to standard treatments. If pivotal study results for the easy-to-swallow combination of AXS-05 continue to impress, those blockbuster sales J&J’s expecting for Spravato will head toward…
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