While there is a lot of fuss about a potential legal market for psilocybin, ketamine is currently where the money is for alternative plant medicine companies. Ketamine clinics are springing up across the country as the total addressable market is estimated to be roughly $16.2 billion.
There have been a few small studies that have suggested ketamine as a drug to treat depression. Traditional antidepressants zero in on the brain's serotonin and noradrenaline systems, whereas ketamine's approach is to block a receptor called NMDA, which is activated by the neurotransmitter glutamate. A small dose given through an IV has shown to stem symptoms of severe depression in some patients with treatment-resistant depression within hours.
"We haven't had anything really new for about 50 or 60 years," said Allan Young, professor of mood disorders at the Institute of Psychiatry, Psychology and Neuroscience at King's College, London, at a briefing on July 12 at London's Science Media Centre when asked about ketamine. He said, "Most of the new launches have been tinkering with drugs which were really discovered in the '50s and '60s. Even the famous Prozac, which came in in the late '80s, is really just a refinement of the tricyclic antidepressants that came in the '50s. People say we are still in the age of steam, and we need to go to the next technological advance."
Ketamine Has FDA Approval
"It has been easier to get started working with ketamine because of legal and regulatory reasons," said Ronan Levy, Executive Director at Field Trip Health Ltd. (CSE:FTRP) (FTRPF) . "Ketamine is a legally prescribed drug in most jurisdictions. In the U.S., it's been an FDA approved anesthetic since 1970 with an incredible track record of safety and efficacy both as an anesthetic as well as a mental health treatment. Psilocybin, on the other hand, is still a Schedule 1 drug in the U.S., though that is likely to change soon both at the state level (as ballot initiatives like Measure 109 in Oregon succeed) and at the federal level."
Levy noted that FDA-approved clinical trials using psilocybin could be advancing through Phase 2(b) and Phase 3 with "breakthrough therapy" designation (which is reserved for drugs that treat a serious or life-threatening conditions and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.)
Dr. Roger McIntyre. CEO of AltMed agreed with Levy. "The reason for the relative fast track for ketamine is that ketamine is a bonafide mainstay of medicine for 5 decades. it's a very different runway for knowing the drug and knowing the safety precautions; you have a very short runway, as the NIH developed Ketamine for depression. It's a lot easier to take an FDA agent than taking a brand off the shelf and trying to show that it's safe to the population. Adding to the romance with psilocybin is that it was one that people weren't allowed to do research with. It had a very different starting point. The atmospherics for Ketamine are very different than with psychibil, where it has been branded as for hippies and is DEA enforced."
Clinic patients typically pay between $450 to $500 per treatment and get approximately six treatments. An investigative report by medical online publication Stat found that some clinics don't thoroughly screen patients and could be offering the treatments to anyone willing to pay. The treatments are often not covered by insurance. The report also found that come clinics overhype the efficacy of ketamine by offering it as a treatment for a wide variety of ailments. While professionals may be wanting the clinic industry to pump the brakes, patients are flocking to them.
"The promise of ketamine-assisted therapies, as with all psychedelic-assisted therapies, is to offer people suffering with depression, anxiety, PTSD or other mental or emotional health challenges with a new treatment option that can provide faster acting, and more extended relief with less side effects than conventional antidepressants," said Field trip Health's Levy. "This is the reason we are opening Field Trip Health centers across North America presently, currently operating in Toronto, New York, LA and Chicago. And, unlike conventional antidepressants, psychedelic-assisted therapies may also cause positive side effects including neural plasticity, neurogenesis and increased compassion, empathy and creativity."
Ketamine Clinic Companies
Field Trip Health opened its fourth clinic in Chicago last month. The treatments aren't cheap. It costs $5,700 for six ketamine treatments, but that includes a psychiatric consultation, two psychotherapy sessions six integration psychotherapy sessions and ongoing digital therapy. Every Field Trip Health clinic has a medical director and a psychiatrist on staff to screen patients for safety and fit. All of its psychotherapists have been trained in using specific techniques and protocols during integration therapy.
Dr. Ryan Yermus, Field Trip Health's Chief Clinical Officer said: "The initial clinical results from our first three centers have been extremely positive. The first patients in New York to complete the Field Trip Health course of treatment demonstrated a significant reduction in depressive symptoms from severe or moderately severe to mild or non-existent. This was further accompanied by a reduction in anxiety and trauma related symptoms."
Earlier this year, Psychedelic medicine company Champignon Brands Inc. (SHRMF) said it was buying California based ketamine treatment company Wellness Clinic of Orange County Inc. It was a cash and stock deal with Champignon paying $600,000, plus one million common shares of Champignon and 500,000 common shares of Champignon payable only if the Wellness Clinic collects top-line revenue of at least $1,500,000, over the 18-month period. In May the shares were trading at a price over $1, but they have since fallen to roughly 50 cents per share.
Champignon also plans to acquire Canadian ketamine clinic operator AltMed Capital Corp. Champignon said that AltMed has a suite of assets that would hasten its anticipated rollout of new clinics to be opened across the United States and Canada. Five new clinics in key markets, including New York, Florida and California, are anticipated to be fully operational by the fourth quarter of 2020. Champignon will buy all the shares of AltMed putting a value on the deal of approximately $32 million.
Novamind Ventures says it has administered more than 3,000 ketamine-based psychotherapy treatments (more than anyone else in the U.S.) at its clinics in Utah. The company just announced that it has raised C$10M in the latest round of financing as it nears completion of a reverse takeover transaction with Hinterland. After the RTO is complete, Novamind said it will begin trading on the Canadian Securities Exchange under the ticker symbol "NM."
Novamind says it is different from other companies in the space because it is focused on building the infrastructure (a unique combination of clinics and retreats) and protocols to administer various psychedelic compounds combined with psychotherapy. Dr. Reid Robison is the Chief Medical Officer and is an early adopter and researcher of ketamine in psychiatry. He led a pivotal IV ketamine study for treatment-resistant depression by Janssen, leading up to the company's recent FDA-approval of Spravato. The company said that Dr. Robison has guided thousands of ketamine therapy journeys and hundreds of Spravato dosing sessions.
With the state of Oregon's move to decriminalize all drugs, the stigma around compounds like ketamine is lessening. Plus, many patients who have found no relief in standard depression drugs are willing to give this a try. If there continues to be evidence that it gets these patients off of long-term depression drugs, insurance companies may quickly see this as a cheaper alternative and begin covering these treatments.
Levy added, "While the evidence suggests that the antidepressant effects of psilocybin-assisted therapy may be longer lasting (some studies suggest that the anti-depressive effects of psilocybin-assisted therapy can last for 5 years or more), the advantage of ketamine-assisted therapy is that it is legal and accessible in North America now."
Please note that due to factors including low market capitalization and/or insufficient public float, we consider Field Trip Health and Champignon Brands to be a small-cap stocks. You should be aware that such stocks are subject to more risk than stocks of larger companies, including greater volatility, lower liquidity and less publicly available information, and that postings such as this one can have an effect on their stock prices.