In March 2019, the FDA approved Johnson & Johnson’s new depression drug. Company spokespeople have said it uses the “first new mechanism of action in decades.” That means it should work on the body in a new way. But wait . . . Doctors all over the country, including me, are saying it has the same mechanism of action as a generic drug that’s been available for 50 years.
What is Johnson & Johnson’s new depression drug called? The generic name is esketamine – a name based on the drugs forbearer, ketamine. The brand name from Janssen Pharmaceuticals, a Johnson & Johnson company, is Spravato. People are excited about Spravato in part because it’s labeled to treat depression that has proven resistant to normal antidepressant drugs and therapy.
Spravato works in the brain by blocking N-methyl-D receptors. Scientists have long known that these receptors are involved in the processing of physical pain. More recently, we’ve learned that pain processing in the brain has overlapping processes with the processing of stress and depression.
Some doctors dislike that the manufacturers is saying the drug works in a new way. There’s nothing new about an N-methyl-D receptor agonist. That’s how the generic drug ketamine works. Doctors have been using ketamine since the 70s. On the other hand, ketamine is labeled as a surgical anesthetic. It’s only been within the past few years that doctors on the cutting edge of medicine have been using it to treat depression. At the Charlotte Ketamine Center, we’ve been using ketamine to treat depression since 2017.
Even the generic drug name winks at the fact that esketamine is a chemical mirror to ketamine. Ketamine’s chemical structure has a left and right part. Spravato’s chemical structure basically cuts the ketamine molecule in half. That’s why Spravato works just like ketamine. It is ketamine. Just cut in half and delivered in a less effective way.
One would hope that the answer is that the new drug would be better than the generic drug in some way. That’s difficult to demonstrate so far. The clinical trials that Spravato presented to the FDA compared Spravato to placebo, not to its older, generic form. By patenting the halved ketamine molecule as esketamine, Johnson & Johnson was able to make it financially feasible to go through the costly FDA approval process for a depression medication. When science discovers a new use for a generic drug such as ketamine, there’s no way for a company to make the cost of the FDA approval process pay for itself.