Fear & Loathing
There’s several debates raging about which specific psychedelics to get behind, investors are trying to guess which ones will provide the necessary breakthroughs within the medical community to eventually lead to mass adoption.
And there are strong cases for many of them. MAPS’ Phase 3 study on MDMA for PTSD is a recent breakthrough, and psilocybin and LSD are undergoing clinical trials with the likes of Compass Pathways (CMPS.Q), Cybin (CYBN.NE) and MindMed (MNMD.Q) leading the way with psilocybin having the slight edge as 2022 could see the completion of multiple Phase 3 psilocybin trials. And then you have ketamine, a drug that wasn’t getting a ton of buzz in the investor space until all of these ketamine clinics started popping up a couple years ago. When looking under the hood it makes sense that ketamine would take off among health science companies as Pfizer (PFE.N), one of the biggest fish of them all actually synthesized it themselves more than 50 years ago.
Ketamine’s reputation is quickly being restored from a party drug that causes people to feel drunk, and if used in high doses ‘k-hole’, to that of a scientifically proven drug that reduces depressive symptoms over a long period of time. This could potentially disrupt the SSRI/antidepressant market more than any other drug undergoing trials.
I was at a Halloween party sometime around 2010, my cousin was dressed up as Raoul Duke from Fear & Loathing in Las Vegas. He went to town on the costume, the hat, the shirt, the blazer, the sunglasses, the cigarette, and what really made it all believable was that he was really fucked up on ketamine. I brought him to the party with a bunch of my friends from university, he is usually quite sociable but in this occasion he was slurring his words, losing his balance, and eventually broke what looked to be a pretty nice bong as his arms and legs started to lose function. It wasn’t the best introduction.
But it was all in character. No one was upset. My view of ketamine had always centered around this type of experience until a couple years ago when I heard companies were looking at it for its anti-depressive purposes, and namely for usage in psychotherapy. ‘Special K’ as it’s sometimes referred to has a reputation for being a party drug, and that’s the reason why it was made a schedule 1 drug by the US government in the 1980s.
Pfizer & The FDA
Ketamine’s backstory isn’t that different from other psychedelics like LSD, mushrooms or MDMA. Proven clinical applications combined with DIY usage in the party scene that ultimately lead to a blanket decision to just say ‘fuck it, party’s over.’ Ketamine was first synthesized in 1962 by Calvin Stevens at Parke-Davis Co which later changed its name to Pfizer as an alternative anesthetic to phencyclidine and was introduced into clinical practice by 1970.
This black and white approach has been key in the US’ highly unsuccessful war on drugs. Nancy Reagan’s ‘just say no’ campaign perfectly signifies the over simplistic approach lawmakers took with respect to these powerful medicines. But in a somewhat surprising turn of events, in 2019 the FDA approved Sparvato, a ketamine derivative administered by a nasal spray.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition. Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”
– Tiffany Farchione, Director of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research
The efficacy of Spravato was evaluated in three separate 4 week long clinical trials and one longer-term maintenance-of-effect trial. In the three short-term studies, patients were randomized to receive Spravato or a placebo nasal spray. In one of the short-term studies, Spravato nasal spray demonstrated statistically significant effect compared to placebo on the severity of depression, and some effect was seen within two days.
The two other short-term trials did not meet the pre-specified statistical tests for demonstrating effectiveness. In the longer-term maintenance-of-effect trial, patients in stable remission or with stable response who continued treatment with Spravato plus an oral antidepressant experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray plus an oral antidepressant.
Clinics vs. DIY
Sparvato does have some pretty intense side effects, making clinics and medical professionals a vital part of the process. The Spravato labeling contains warning cautioning that people are at risk sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and even suicidal thoughts and behaviors after administration of the drug.
I would assume some of the harsher side effects would be reserved for those with pre-existing mental health conditions, but, it’s important to note people may not be aware of the degree that they are suffering, especially with dissociative types of PTSD. They may also be unaware of how their genetics could contribute to their mental health, an issue Entheon Biomedical (ENBI.C) is working to fix with their new genetic testing kits.
DIY ketamine use for personal growth has not been approved by the FDA, so those who want to follow the proper health protocols should seek out a clinic. Sparvato is the main drug that is used across the board in ketamine clinics in the US and Canada. These clinics can be costly if repeated treatments are needed over a longer period of time, but the clinical trials mentioned above showed long lasting results for aiding in depressive symptoms.
If the drug is extremely effective over a longer period of time repeat customers may be tough to retain year over year, but with the growing body of research and public awareness around the topic, finding new customers, especially coming out of the pandemic may not be so difficult.