Much has been made in the news lately about the US Food and Drug Administration (FDA) approval of esketamine (Spravato), the nasal S-ketamine spray by Janssen Pharmaceutical, a company owned by Johnson & Johnson.
Ketamine is a medicine developed more than 50 years ago for anesthesia during surgery and other painful procedures. High-dose ketamine has been used safely for that purpose in children, adults, and animals for decades. About 16 years ago, medical researchers began studying low-dose intravenous ketamine infusions for treatment-resistant mood disorders, including depression, anxiety, and post-traumatic stress disorder (PTSD). Since then, studies have proven conclusively that the drug not only works but works quickly, with significant and lasting relief within hours of the first infusion.
Because ketamine has been around for so long, it is not patentable. This means that big pharma cannot make big money selling it because it is generic and inexpensive. Like many drugs, ketamine is a mixture of two molecular forms, the R-isomer and S-isomer, which are mirror images of each other. What Janssen has done is to isolate the S-isomer, S-ketamine ("es-ketamine"), and patent the isolate and its delivery by nasal spray. They haven't invented anything new or even tweaked the molecule a bit.
Researchers have examined the effectiveness of both the R- and S-isomers of ketamine and found that neither is as effective alone as the mixture is together. To support their application, Janssen submitted results from five randomized controlled trials of esketamine to the FDA. Only 2 of 5 studies showed a significant benefit for esketamine. Two out of five! That's 40%, which would be a failing grade in any classroom. Furthermore, Janssen used non-standard measures to define “remission” of depression in their studies, which made it easier to show a difference with esketamine. Had they used standard accepted definitions, it is doubtful that even their two “positive” studies would have shown the drug to be effective.
Not only is the S-isomer less effective, but the delivery by nasal spray is unpredictable. What if your allergies are acting up and you have a nose full of mucus? How much drug do you think your nose will absorb? This is exactly what Janssen's studies found. Unpredictable absorption! One day you get a good dose, then next not so much. The next, too much!
Finally, the likelihood that the nasal spray will get into the hands of those who would abuse it is incredibly high. Imagine people going through your medicine cabinet and swiping your spray. The same happens with pain pills all the time. Why would esketamine be any different?
Given these criticisms, why would the FDA approve Spravato? I'd like to think it is because it does work for some patients. Far more likely, however, is the fact that Janssen stands to make a killing selling this "new" drug. Anytime large sums of money are involved, the potential for greed to shape decision-making is significant. I believe that this is exactly what we are seeing here, a greedy grab selling an inferior form of a medication that is anything but new or novel.
Supporting this claim, in early March Johnson & Johnson announced that Spravato will be priced at $590 for a 56 mg dose and $885 for 84 mg. That is PER DOSE. During the induction phase of the therapy, which lasts for a month, patients will be treated twice a week with either dose, resulting in a wholesale acquisition cost or list price in the range of $4,720 to $6,785. Subsequent maintenance doses will be provided either once a week or every two weeks, adding up to monthly costs ranging from $2,360 to $3,540, or $28,000 to $42,000 per year.
In comparison, intravenous ketamine therapy at The Infusion Clinic of Ocala costs $349 per dose, for an initial induction phase cost of $2094. Subsequent maintenance doses are given approximately every 1 to 6 months, for a maximum yearly cost of $4188. Yes, it requires an IV and 40-minutes of your time, but there are a lot of things you could do with that $23,000+ price difference, even if your insurance company covers some of it.
In summary, if you are depressed, anxious, or have PTSD and haven't gotten relief from counseling or traditional antidepressants, give generic IV ketamine infusion therapy a try. It is proven to work in 3 out of every 4 treatment-resistant patients. It is safe and predictable. If you would like to give it a try, our clinic has lots of openings and the cost of an infusion is only $349. There is no better time to try!
You can find out more about IV ketamine therapy in the January issue of Health & Wellness Magazine (https://tinyurl.com/y7sursfq), online at https://www.InfusionClinicOcala.com, or by calling The Infusion Clinic of Ocala at (352) 325-5755.
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