Why has there not been a massive FDA approved study of Ketamine?

There have been hundreds of peer reviewed studies of Ketamine showing it’s effectiveness over the years and yet it is still only prescribed off-label for infusions and thus not eligible for insurance reimbursement (although we do accept HSA and FSA to use pre-tax dollars and will provide a superbill to help you use with your private insurer towards your deductible – check out our blog on tips for reimbursement.) Many people wonder why then, if there has been such a growing mountain of evidence to show its effectiveness, have Jassen and other Big Pharma companies not simply researched ketamine for mental health to get it FDA approved?  The Answer… money.  

The FDA grants approval for a particular indication, with specified dose ranges, and route of administration.  When any of these parameters are changed, the prescription is off-label (by the way, more than 21% of all prescriptions are written off-label). Since ketamine’s patent expired in 2002, companies cannot make a profit from studying or marketing the drug. Pharmaceutical companies would have to spend hundreds of millions of dollars to have it recertified by the FDA for other uses/dosages. This is why Spravato (Esketamine) a nasal spray version of a slightly altered ketamine chemical was created and why insurance will cover it. Unfortunately, most studies find the efficacy to be significantly lower, the first-pass metabolism is low as the portion that gets absorbed through the sinus will travel to the brain without first-pass metabolism but some will run down the back of the throat where it will be metabolized. The result is that the rate of delivery to the brain with nasal ketamine (spravato, esketamine) is uncontrolled and highly variable, and is the reason why we at NeuConnections consider IV Infusion to be the Gold Standard as the there is no first-pass metabolism, 100% of an infusion reaches the bloodstream without being metabolized, and the rate of delivery to the brain is controlled, exact, and can delivered at a precise rate which can be adjusted at any time. 

That said, given the cost prohibitive nature of Ketamine IV Infusions for some, we are absolutely supportive nasal spray ketamine but we recommend researching your true cost comparison when you factor in your deductible. Finally, off-label use of ketamine is consistent with good medicine. In regard to the current FDA approval, ketamine used for mental health, chronic pain, and migraines, is incredibly safe as the dosage is a fraction of what it is approved for by the FDA in anesthesia and procedural sedation.