A Ketamine-Like Drug Is the First New Antidepressant to Get FDA Approval in Years

Julia Belluz, writing for Vox:

Ketamine, which has long been used as an anesthetic, has increasingly been tried off-label by psychiatrists as a last-ditch effort to treat the 12 to 20 percent of adults with depression who don’t respond to other antidepressant medications or treatments.

Building on years of preliminary research about ketamine’s potential benefits for depression, Johnson & Johnson developed a drug called esketamine, sold under the brand name Spravato. The nasal spray is designed to alleviate depressive symptoms within hours — much faster than the other antidepressants on the market, such as Prozac, which can take weeks or months to act.

In February, an FDA panel determined, in a 14-2 vote, that esketamine’s benefits outweigh its risks and recommended that the agency approve the drug. The approval came on Tuesday, the first new antidepressant type to be greenlit by the agency in decades.

At first glance this may sound like good news, but weekly supervised administrations of esketamine will only be available for:

  1. Adults suffering from treatment-resistant depression,

  2. Who are also taking another oral anti-depressant, and

  3. Have access to a certified clinic where patients can be monitored for two hours after taking the drug.

Oh, and it’s going to be prohibitively expensive for most. While street ketamine is relatively expensive (typically $70-100 per gram), these nasal spray esketamine treatments will cost patients “anywhere between $2,360 to $2,540 a month.”

And the controversy doesn’t end there, either. Some physicians like psychiatrist Erik Messamore have a few problems with this news:

We’ve known since at least 2006 that ketamine (old, cheap, generic ketamine) rapidly shrink depressive symptoms. The antidepressant response occurs in a matter of hours and can last for up to a week after a single dose. […]

We didn’t need eskatamine, really. We just needed a way to get 2006 medical science discoveries into clinical practice in less than 13 years. […]

-Without FDA approval, insurance companies will find a convenient excuse not to cover treatments – even if medical science shows that the treatment is useful.

-Only pharmaceutical companies have enough money to get the FDA to look at data and opine on effectiveness.

-Pharmaceutical companies won’t spend a dime to ask the FDA to review generic drugs like ketamine (or natural products like fish oil)

-We do not have organizations [that] are reliably willing to review non-industry-sponsored science and make recommendations about when a generic drug or natural product should move into clinical practice.

Similar issues are emerging in the psilocybin space right now too. In the midst of all the excitement with psychedelic drugs being medicalized, we should remain aware of the potential problems we face with only allowing certain populations of people have access to these tools—and with letting Big Pharma reap all of the profits that should instead be going toward the brave people who belong to a movement the industry has fiercely attempted to stave off for decades.