4 ms·
That's not how the drug approval process goes in this country, for better or worse. Also noted some misinformation in the comments. FDA will approve drugs from
by epmaybe 8y ago
That's not how the drug approval process goes in this country, for better or worse. Also noted some misinformation in the comments.
FDA will approve drugs from companies or individuals that pay for the application. The cost is pretty high today, something on the order of $2-3M USD just for the application. That's not including the cost of supporting data you need to have (Phase 1-3) that will likely cost a large amount to support (multiple centers, paying participants, wholesale cost of drug, paying investigators, researchers, statisticians, etc). Side note, should companies be able to justify exorbitant prices for their drugs based on this cost? No, probably not, but smarter people than myself have debated this on HN.
Why do I mention this? Because ketamine for use in intranasal form for treatment of depression is not off patent. That's right, Mount Sinai Hospital (Icahn School of Medicine) was granted that patent in 2007. A non-profit institution, mind you. So, if I were a drug company, looking to make a profitable form of intranasal ketamine, wouldn't I try and sidestep the patent entirely, reducing overhead on my end?
Also, calling esketamine a knock off is disingenuous. It's an enantiomer, therefore literally half of what is in normal ketamine. It's also probably the more potent half.
Edit: originally wrote that ketamine patent was granted in 2017, meant 2007.
Edit2: originally wrote that NYU held the patent to intranasal ketamine when it was actually Mount sinai hospital.