- 3 weeks ago
- Wedding: November 2010
Thought some of you might be interested in where ketamine is in the process of getting FDA approval for use in treating depression, chronic pain, PTSD (especially effective), and other conditions for which it has proven successful.
As always, my gratitude goes to our own dear Pantsapocalypse for inspiring me to get into the whole ketamine thing. So many wonderful things have happened, it’s been life changing.
Unfortunately, the cost has kept out many people who would benefit from this treatment. Ketamine is an old anesthetic, in use for about 50 years. I’m told it’s the safest anesthetic available as it does not suppress the respiratory or cardiovascular system. It is still in use, including for pediatric surgery.
The doses used therapeutically are much smaller than anesthetic doses or amounts used by drug abusers.
Since it is FDA approved as an anesthetic, using to treat depression or any other condition is an “off label” use. It’s perfectly legal to use it off label. I haven’t been able to confirm this, but it seems likely that the FDA would designate ketamine use as anything other than anesthesia to be “experimental” as well.
All of which means that insurance companies don’t have to pay for it. The patent on ketamine expired a long time ago, so there’s no financial incentive to spend enormous amounts of money to shepherd the stuff through the approval process.
However, researchers have developed a synthetic ketamine, “Esketamine”. A company named Janssen, which is owned by J & J, is taking it through FDA approval. The normally sclerotic FDA has designated Esketamine a “breakthrough” drug, based on it’s effectiveness in preventing suicide. That designation puts it on a fast track. Janssen submitted their application early September 2018.
At this point, they’re only seeking approval for a nasal spray. But, it’s a start.