An FDA advisory panel voted this week that a new form of an old compound is sufficiently safe and effective to be considered for approval. The old compound is ketamine, which has been used as an intravenous anesthetic since 1970. The new formulation is esketamine nasal spray. Janssen, a division of Johnson & Johnson, hopes that the FDA will approve this as a new antidepressant. That would make it the first new type of antidepressant since 1984.
What Did the Panel Think About Esketamine Nasal Spray?
The advisory panel voted overwhelmingly that the drug is safe and effective and that its benefits outweigh its risks. However, the experts based their evaluation on relatively short-term clinical trials. At least one of those did not show that the drug is more effective than placebo.
J&J is developing esketamine nasal spray to treat people with severe depression who have not responded well to other treatments. The drug can cause side effects such as a metallic taste, vertigo and dizziness, drowsiness, headache, nausea, and most worrisome, mind-body dissociation. FDA’s approval decision is scheduled for March 4.
What Do We Already Know About Ketamine for Severe Depression?
This is not the first we have heard of ketamine acting against depression. Back in 2012, we heard from one reader who had severe chronic depression.
Q. I participated in two clinical trials of ketamine for depression. The infusion was not pleasant, but a few hours later my depression was mysteriously lifted. I felt as though someone carefully cleaned, polished and rejuvenated every cell in my brain. It was not a feeling of being high; it was completely different from anything I had ever experienced in my entire life.
Unfortunately, it only lasted a few days. When it went away, I returned to life as I had always known and felt even more horrible. They told me up front it is a clinical trial and the drug is not available for depression treatment. But it is an FDA-approved medication. Any MD could prescribe it, but no one has been willing to administer it.
I have felt closer to suicide at times since I found out how good other people feel every day. Hopefully, ketamine will soon be approved for severe depression.
Frustrations in Treating Major Depression:
A. Psychiatrists find it challenging to treat major depression like yours. Current antidepressants may take weeks to start working. Clinical trials reveal that only about a third of patients achieve good results, even after optimal therapy (Rush et al, American Journal of Psychiatry, Nov. 2006).
Ketamine (Ketalar) is a unique injectable anesthetic that has been used in surgery since the early 1970s. More recently, scientists have been studying ketamine infusions for the treatment of major depression.
Preliminary studies suggested that intravenous ketamine might relieve severe depression rapidly even for those with treatment-resistant depression (Covvey et al, Annals of Pharmacotherapy, Jan. 2012). This is still very much an experimental approach, however.
Why Turn to Esketamine Nasal Spray?
Many doctors have been somewhat reluctant to prescribe ketamine for depression because the effect is short lived. In fact, some people report that relief lasts only a few days. Moreover, ketamine has been abused as the club drug “Special K.” In addition, oral or intravenous ketamine can cause hallucinations and changes in heart rate and blood pressure. That is probably why J&J is counting on esketamine nasal spray to provide help for depression while limiting side effects and potential for abuse.
For more information on intravenous ketamine for treating depression, listen to this report from NPR.
You may also find our Guide to Dealing with Depression of value.