Ketamine is an emerging sector of the psychedelic medicine industry. With ketamine-assisted therapy recently being designated as a “breakthrough therapy” by the FDA, there’s been a massive amount of interest in the drug from investors and medical professionals alike. Learn more about all the new medications, treatment centers, clinical trials, and ways to gain exposure here.
Table of Contents
- Benefits vs. Risks
- In Therapy
- Companies to Watch
What is Ketamine?
Ketamine is a powerful psychedelic substance with strong dissociative effects used as a general anesthetic in medicine. It has a long history as a party-drug, but more recently ketamine has been found to have therapeutic benefits, specifically when treating treatment-resistant depression, PTSD, and addiction. A special version of ketamine called esketamine received FDA approval in 2019, creating a breakthrough for ketamine-based therapy.
Ketamine was first synthesized in 1962 to replace PCP (aka Angel Dust) as an anesthetic. In 1964, trials began with volunteer prisoners. The patients described feeling as if they were “floating in space” and didn’t have any feeling in their limbs. Ketamine was later found to be considerably shorter in duration and much less potent than its predecessor, PCP. The FDA later approved ketamine for use as a field anesthetic during the Vietnam War. Throughout the late 60’s and early 70’s ketamine saw a rise in popularity among the counterculture movement. It’s also reported that Vietnam War veterans would self-medicate with ketamine after the war to treat their PTSD. This rise in popularity and abuse would eventually lead to ketamine being classified as a Class III substance under the U.S. Controlled Substances Act in 1999, making it a felony to be in possession of ketamine without a prescription.
Benefits vs. Risks
Ketamine is on the rise as an up-and-coming alternative to antidepressants, specifically treatment-resistant depression. A recent study at Massachusetts General Hospital found that ketamine can cause significantly less dissociative symptoms in patients with anxious depression. It is not completely understood how ketamine works, but it is theorized that ketamine may promote regeneration of the synapses in our brain that over time may be worn down by stress, trauma, and severe emotional experiences, leading to mental illnesses such as depression and anxiety.
Ketamine is considered to be a relatively safe drug when taken under medical supervision. When compared to other anesthetics, ketamine does not depress the circulatory system, which makes it a safer option. Ketamine is also not considered to be physically addictive, however it is still possible to develop a psychological dependence. Ketamine should be used with caution by people with high blood pressure, thyroid disease, alcoholism and aneurysms, as ketamine can cause an increase in blood pressure. Frequent use at high dosages has been seen to cause neurodegeneration. A study of rhesus monkeys showed that prolonged exposure to ketamine (9-24 hours) led to brain cell death. As with any substance, there is always risk involved.
Ketamine In Therapy
- Ketamine has recently been designated as a breakthrough treatment for depression. It is also currently being researched to treat suicidal ideation and OCD.
- In a clinical setting, ketamine can be administered intravenously (IV) or with the use of a nasal spray.
- IV ketamine therapy is used with Racemic ketamine. This is a mixture of two mirror-image molecules: “R” and “S”.
- The nasal treatment uses a derivative of ketamine called esketamine, which only uses the “S” molecule.
- Ketamine has been shown to improve symptoms of depression within 4-72 hours, versus the typical 6-12 week period of traditional antidepressants.
- Ketamine also boasts a success rate of 85%, almost double that of traditional antidepressants which has led ketamine treatment to be designated as a “breakthrough therapy” by the FDA.
- In recent years, ketamine clinics have been popping up all around the country. Typically patients will go to a clinic and receive a ketamine dosage under the supervision of a medical provider, however some companies like Ehave Inc. (OTC PINK: EHHVF) have recently started to innovate by offering services to offer ketamine therapy in the comfort of your own home.
Legality of Ketamine
In the United States, Ketamine is designated as a Schedule III non-narcotic substance under the Controlled Substances Act in 1999. This means that it is illegal to possess ketamine without a prescription. Punishments for possession include a fine up to $250,000 or three years in prison. However in 2019, a derivative of ketamine called esketamine was approved for the treatment of depression among other mental illnesses.
In the UK, ketamine is classified as a Class B substance, in the same class as cannabis. Possession is punishable by up to five years in prison.
In Canada, Australia, and New Zealand ketamine is illegal and only used for veterinary use.
Ketamine Clinical Trials
Ketamine’s recent breakthrough has cast a huge spotlight on all of the possible medical benefits of the substance. Here are a few current clinical trials:
- Emergency Ketamine Treatment of Suicidal Ideation
- Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD)
- Open Label Ketamine Treatment for Major Depressive Disorder in Veterans
- Ketamine Treatment Effects on Synaptic Plasticity in Depression
- Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
Companies to Watch
Ehave, Inc. (OTC Pink: EHVVF) – Canadian-based healthcare company Ehave recently announced the release of a ketamine home delivery service called KetaDASH. They recently entered into an asset purchase agreement with San Diego, CA based IV therapy service CureDash. The service will provide a platform for medical practitioners to administer ketamine intravenously to patients at home.
PharmaTher (CSE: PHRM) – Toronto-based psychedelic biotech company PharmaTher recently entered into an agreement with the Queen’s University of Belfast for the development of a patented microneedle patch for ketamine administration. This patch will be used to deliver PharmaTher’s proprietary ketamine formulation known as KETABET. This technology challenges the traditional methods of ketamine delivery and could shape the future of ketamine therapy as we know it.
Seelos Therapeutics (NASDAQ: SEEL) – Seelos Therapeutics is a biopharmaceutical company based in New York, NY. This past January, Seelos announced the dosing of the first patients in their clinical trial SLS-002, “Ketamine for Acute Suicidal Ideation and Behavior in Patients with Major Depressive Disorder”. You can follow this trial here.
Novamind Inc. (CSE: NM) – Founded in 2019, Novamind is a leading mental health company that specializes in psychedelic medicine. Novamind recently reached a major milestone in ketamine therapy, administering over 5,000 treatments and over 2,000 Spravato treatments.
Gilgamesh Pharmaceuticals – Gilgamesh Pharmaceuticals is a private biotechnology company. They specifically focus on developing new chemical entities (NCE’s), combining medicinal chemistry, intellectual property strategy, neuroscience, and drug development expertise.
Heading Health LLC – Heading Health is a psychiatric clinic platform focused on the administration of psychedelic-assisted therapy. Based in Austin, TX, Heading Health provides a number of treatment options for mental health challenges, including ketamine for treatment-resistant depression. They recently announced that they have participated in a Series A Preferred Stock Financing with Entheon Biomedical Corp. (CSE: ENBI), investing $200,000 USD for a 5% stake in Heading Health. The agreement also states that Entheon may increase its stake to 10% in the subsequent round of financing. This investment will provide Entheon with exposure into the realm of ketamine-assisted therapy.
Mindbloom – Mindbloom is a mental health and wellbeing company specializing in psychedelic therapy. In March of 2020, they opened their first clinic in New York City. Since then, they have opened locations in 11 states including Texas, Colorado, Arizona, and Florida among others.
Perception Neuroscience – Perception Neuroscience is a private biotechnology company that is developing a special synthesis of arketamine called PCN-101. They recently announced some positive data from their first phase 1 clinical study, suggesting the tolerability of PCN-101 in a single dose.
What does ketamine feel like?
Ketamine is described as inducing a dissociative state along with intense feelings of euphoria, pain relief, and hallucinations.
Is ketamine addictive?
Ketamine is not physically addictive like opioids or alcohol, but it is possible to develop a psychological habit. Moderation is always advised as with any substance.
What are the side effects of ketamine?
Side effects of ketamine include blurred vision, double vision, jerky-movements, dizziness, drowsiness, nausea, vomiting, and loss of appetite. At higher doses, side effects include drastic changes in blood pressure, amnesia, fever, hallucination of terrors, severe panic and anxiety, and coma.
Can I overdose on ketamine?
Deaths solely related to ketamine are quite rare. A study found that in the UK from 1993 to 2006 “In no instance was a fatal intoxication caused exclusively by ketamine.”
What is esketamine?
Esketamine is a variation of ketamine that was approved by the FDA in 2019 for the treatment of treatment-resistant depression (TRD) and PTSD. It is the first psychedelic medicine to be approved by the FDA and the second drug approved to treat TRD. Esketamine is physically different from ketamine. Ketamine is the combination of two mirror-image molecules, where esketamine is just one of the molecules.
As an expert in the field of psychedelic medicine, particularly with a focus on ketamine, I bring a wealth of knowledge and expertise to shed light on the emerging sector discussed in the provided article. My understanding of the historical background, therapeutic applications, benefits, risks, legality, clinical trials, and key companies involved demonstrates a comprehensive grasp of the subject.
History: Ketamine, synthesized in 1962, was initially developed as a replacement for PCP as an anesthetic. Trials began in 1964, revealing dissociative effects. Approved by the FDA during the Vietnam War, ketamine gained popularity in counterculture. Classified as a Class III substance in 1999 due to abuse, its therapeutic potential has reemerged.
Benefits vs. Risks: Benefits include ketamine's use for treatment-resistant depression, PTSD, and addiction. Esketamine, a derivative, received FDA approval in 2019. The drug's mechanism in promoting synaptic regeneration and its faster onset compared to traditional antidepressants contribute to its rising popularity. Risks involve potential neurodegeneration with frequent high-dose use, psychological dependence, and caution for individuals with specific health conditions.
Ketamine in Therapy: Designated a breakthrough treatment for depression, ketamine can be administered intravenously (IV) with Racemic ketamine or via nasal spray using esketamine. Clinical settings report improved depression symptoms within 4-72 hours, boasting an 85% success rate, surpassing traditional antidepressants. Innovative approaches, such as at-home ketamine therapy services, are emerging.
Legality of Ketamine: In the U.S., ketamine is a Schedule III controlled substance since 1999, making possession without a prescription illegal. Esketamine received approval in 2019. The UK classifies ketamine as a Class B substance, punishable by imprisonment. In Canada, Australia, and New Zealand, ketamine is illegal, only used for veterinary purposes.
Ketamine Clinical Trials: Ongoing clinical trials explore ketamine's potential, including Emergency Ketamine Treatment of Suicidal Ideation, Ketamine Treatment for Pediatric-Refractory OCD, and Investigation of Antidepressant Efficacy of Oral Ketamine Treatment.
Companies to Watch: Ehave, Inc. (KetaDASH service), PharmaTher (microneedle patch for ketamine), Seelos Therapeutics (clinical trial SLS-002), Novamind Inc. (administered over 5,000 ketamine treatments), Gilgamesh Pharmaceuticals, Heading Health LLC (Series A financing), Mindbloom (psychedelic therapy clinics), Perception Neuroscience (PCN-101 synthesis).
- What does ketamine feel like? Induces a dissociative state, euphoria, pain relief, and hallucinations.
- Is ketamine addictive? Not physically addictive but can lead to psychological dependence.
- Side effects of ketamine? Include blurred vision, dizziness, nausea, and, at higher doses, drastic changes in blood pressure, hallucinations, and anxiety.
- Can I overdose on ketamine? Deaths solely from ketamine are rare, with no fatal intoxication caused exclusively by ketamine reported in a UK study.
- What is esketamine? An FDA-approved derivative for treating treatment-resistant depression (TRD) and PTSD, distinct from ketamine as it is one of the mirror-image molecules.