Those doubting that ketamine and similar compounds will come to play a major role in treating depression were handed more ammunition yesterday. Researchers have found that ketamine’s anti-depressant action, previously though to rely on NMDA modulation, also requires activation of opioid receptors. This could complicate Johnson and Johnson’s efforts with a related project, esketamine, which is due to be filed for approval later this year. With the US in the midst of an opioid addiction crisis this finding will raise big red flags at the FDA - at the very least J&J could be forced to focus esketamine on a narrow patient population. Underwhelming phase III readouts have already prompted a drop in sales forecasts, and the outlook for J&J’s biggest pipeline hopes is now even poorer. Another player in this field, Allergan, could also be hit, Ronny Gal at Bernstein believes. One of the selling points of its related project rapastinel is that it does not activate opioid receptors and thus does not represent an abuse risk. However, it has also relied on evidence supporting ketamine’s effectiveness in depression to justify its development. Now with mechanistic differences showing, Allergan will have to work even harder to prove rapastinel’s worth – with pivotal data due to start emerging early next year, the risks around this project have also risen a notch or two.
|On ketamine's coattails?|
|Project||Company||2022e sales forecast||6-mth change in 2022e forecast|