The FDA just approved ketamine for pain, but they have their eyes on something else.

Welcome to the Carlet Psychiatry podcast, keeping psychiatry honest since 2003.

I'm Chris Aiken, the editor-in-chief of the Carlet Psychiatry Report.

And I'm Kelly Newsom, a psychiatric MP and a dedicated reader of every issue.

We're going to interrupt our series on starting a psych med to bring you breaking news about ketamine.

This month, the FDA made two critical decisions that move ketamine, the original racemic ketamine, closer to approval

and depression. The first, on August the 8th, they approved KetaRX, an intramuscular

ketamine for surgical pain. Number two, three days later, on August 11th, the FDA fast-tracked

a patented intravenous ketamine, NRX-100,

toward a possible indication for suicidality in depression.

In today's episode, you'll learn why this matters in a world where intranasal s ketamine

is already approved as bravado for depression,

and how these new companies are planning to change psychiatry as they expand their products.

First, let's look at how they are even able to do this with a drug that has been on the market since 1966,

when ketamine was launched as a dissociative anesthetic.

Companies can claim a new patent on an old drug if the drug is already generic

and the FDA thinks they have something new to offer. The idea here is that it's not the

chemical itself that is being patented, but a novel idea, like using doxapine at a low dose

to treat insomnia. That is how Silenor

gained a patent for the 3 and 6 milligrams doxapin dosages in 2010. These are called secondary

patents, and some of the ways that companies can achieve this are...

1. A new formulation like XR or O'DT.

...