The US Food and Drug Administration is on the brink of approving a breakthrough drug that could upend the way severe depression is treated.
Johnson & Johnson’s esketamine, a close chemical cousin of the anesthetic ketamine, cleared a major hurdle on Tuesday when a panel of outside experts recommended that the FDA approve the treatment. The fast-acting antidepressant, administered via a nasal spray, is being tested in major depressive disorder and suicidal thinking. If approved, it would be the first major therapeutic advance for depression since the introduction of Prozac in 1987.
Prozac and other currently available antidepressants take weeks to work and don’t help all patients, so esketamine could mark a significant shift in depression therapy.
The panel voted 14-2 with one abstention that the benefits of the drug and a safety program proposed by the company to keep it from being misused outweigh the risks of abuse.
“I believe esketamine has the potential to be a game-changer in the treatment of depression,” Walter Dunn, a panel member and a psychiatrist at the West Los Angeles Veterans Administration Medical Center, said after the vote. “The rates of response in this treatment-resistant population are better than we’ve seen. The rapid timeline of response is better. There’s nothing approved that gets patients better this fast.”
Amid the opioid addiction and overdose epidemic in the US, the panel of experts weighed the abuse potential of ketamine, which at much higher doses is a party drug and can put users into a “k hole” in which they’re unable to interact with the world around them. In a report ahead of the meeting, agency staff called ketamine abuse “relatively uncommon,” with just 1.3 per cent of people over age 12 abusing the drug, lower than the abuse rates for other hallucinogens like ecstasy and LSD.
— Bloomberg
