FDA panel backs Janssen's fast-acting depression treatment

The lack of available treatment options swayed a 14-2 panel vote in favor of recommending approval of intranasal Spravato esketamine (formerly JNJ-54135419) from Janssen Pharmaceuticals Inc. to treat patients with treatment-resistant depression. If approved, Spravato would provide patients that have failed more than two depression treatments with a drug designed to be effective within days rather than weeks.

One panelist from FDA's Psychopharmacologic Drug and Drug Safety and Risk Management advisory committees abstained from the vote on the (S) enantiomer of ketamine. The therapy's PDUFA date is March 4. ...