KETAMINE FOR DEPRESSION: THE QUEST FOR FDA APPROVAL

It’s a frustrating situation, to have this miraculous drug – a drug that is capable of changing and saving lives – so readily available, and yet so inaccessible. Without FDA approval, the overwhelming majority of insurance companies will not cover the cost of ketamine infusion therapy, leaving millions of Americans to suffer in the despair of severe depression. Private label ketamine clinics are operating around the country, but average prices of $500-800 per infusion are inhibitive at best. Even at our clinic, offering the lowest-priced ketamine infusions in the country, this potentially life-changing treatment is still not an option for many people.

Ketamine is a generic pharmaceutical that has been FDA-approved as an anesthetic and pain medicine since the 1970’s. Because the drug cannot be patented – and because financing the clinical trials needed for FDA approval is wildly expensive – no pharmaceutical companies are champing at the bit to obtain approval. The fact that this drug could truly revolutionize the way that we treat depression and other psychiatric disorders – that we could bring new hope to those who are suffering – is not a factor for big pharma.

Now, as MedPage Today reported in a recent article, there is FDA data to support the use of ketamine as a treatment for depression. With no large, randomized, controlled trials of ketamine as an antidepressant, a team of researchers at the University of California San Diego turned to the FDA Adverse Events Reporting System to see if there was any correlation between patients using ketamine for pain and their reported levels of depression. They found that “the reduction of depression rates in ketamine patient records makes a case for the study of ketamine as a psychiatric drug,” and that the patients using ketamine reported depression at a significantly less frequent rate.

This is not the first report of data supporting the antidepressant merits of ketamine. Since 2012, there have been countless studies published, all of them saying the same thing: ketamine is the most remarkable depression treatment we’ve seen, rapidly and safely improving depressive symptoms in 70% of patients, including those who have resisted other treatment methods. There are still questions about exactly how ketamine works, but report after report continues to indicate that it does. 

Janssen Pharmaceuticals is underway developing a patentable isomer of ketamine, called Esketamine, which has been fast-tracked for FDA approval. In the meantime, people experiencing debilitating depression continue to find hope in the halls of private label ketamine clinics across the country. We are one of them. We have seen this drug perform miracles; we have seen the light go back on in someone’s eyes; we have seen them begin to live a rich and fulfilling life for maybe the first time ever.

CONTACT VITALITAS

If you are one of the 70 million people suffering from depression, bipolar disorder, anxiety, PTSD or chronic pain and have exhausted your options, ask us if ketamine infusion therapy is an option for you. Just complete the brief form below and we will contact you to schedule a call or consultation to answer your questions and determine the most appropriate next steps for you.

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