A first-of-its-kind treatment for depression got a big nod from a group of scientists convened by the US Food and Drug Administration on Tuesday.
Experts concluded that the drug, called esketamine and inspired by ketamine, is safe and effective. In addition, they said the drug’s benefits outweighed its risks.
Their input will play a key role in the FDA’s final approval decision, expected in March.
If given the official green light, the drug would be the first novel therapeutic for depression in 35 years.
A drug inspired by ketamine, which has been called ” the most important discovery in half a century,” is on the cusp of becoming the first new kind of depression medication in 35 years.
Called esketamine and developed by Johnson & Johnson, the drug is a nasal spray designed to treat severe forms of depression that don’t respond to other medications. The therapeutic is the chemical mirror image of ketamine and is thought to have slightly fewer side effects than the original compound.
On Tuesday, a panel of outside experts convened by the Food and Drug Administration voted 14-to-2 in favor of the drug’s effectiveness and 15-to-2 in favor of its safety. Their recommendation will play a key role in the FDA’s approval decision for the drug. In addition, they voted 14-to-2 that the drug’s benefits outweighed its risks.
“I think there’s substantial evidence that this could be a game-changer,” Steven Meisel, a system director of medication safety with Fairview Health Services and one of the panel’s 17 voting members, said on Tuesday.
If the FDA gives final approval – a decision is expected in March – the new drug would be the first federally-approved depression drug to work differently from existing depression medications that have been on the market for nearly four decades.
That’s a significant milestone. Depression is the world’s leading cause of poor health and disability, and as many as one in three patients don’t get relief from current antidepressants.
Analysts are hopeful that J&J’s new drug could help.
“Ultimately, we think [esketamine’s] risk-benefit profile favors approval, especially in a disease paradigm where little options are available,” Carter Gould, the executive director of biotech equity research at UBS, wrote in a note circulated last week.
The emerging science on ketamine
Whether it’s Abilify or Zoloft, almost all current antidepressants work by plugging up the places where our brain takes up serotonin, a chemical messenger that plays a key role in mood.
Ketamine appears to engage a different part of the brain from traditional antidepressants, which is part of the reason it’s been called “the most important discovery in half a century” for mental illness.
The drug’s apparent rapid-fire effects may be especially useful for staunching suicidal thinking in people who are considering taking their own lives, experts say. Ketamine also has a long history of being used to prevent pain, which suggests to clinicians that it’s relatively safe.
Source:: Daily times