Years after essentially throwing in the towel after expensive research and development that didn’t pan out, Big Pharma might be feeling pressure to join forces with psychedelics firms to develop mental health treatments.
It’s been a rough road for some of the major pharm companies. Even the antidepressant pharmaceuticals developed and sold by companies like Pfizer, Teva, and Takeda created bigger problems when patients got addicted to them.
Now there is new movement among Big Pharma to find new and better treatments for depression, Alzheimer’s, and other brain-related and mental health maladies – and psychedelics may have a role to play.
Problems with Traditional Pharma
Big Pharma needs the help. Take Alzheimer’s. On June 7, 2021, the FDA provided accelerated approval for the newest medication, aducanumab, which helps to reduce amyloid deposits in the brain and may help slow the progression of Alzheimer’s.
But there’s a problem with aducanumab.
According to an editorial in American Family Physician, aducanumab causes amyloid-related imaging abnormalities, including cerebral edema (35% of treated patients) and cerebral hemorrhage (21% of treated patients). In some patients, these changes were associated with headache (47%), confusion (15%), dizziness (11%), and nausea (8%).
Although these abnormalities generally resolve with discontinuation of the medication, the FDA recommended performing brain magnetic resonance imaging at baseline and before the seventh and 12th infusions, with discontinuation of the medication if abnormalities are seen. Long-term safety is not known.
There were disagreements within the FDA about approving the drug. And it’s incredibly expensive. According to the AFP editorial, for a person weighing 163 pounds, the manufacturer initially estimated that aducanumab would cost $56,000 per year in the United States. (It recently reduced the estimate to $28,200.)
This does not include physician fees and the cost of multiple magnetic resonance imaging scans to monitor for amyloid-related imaging abnormalities.
On the other hand, a study found psychedelics efficacious in successfully treating Alzheimer’s, with healing effects lasting up to several months after a single administration.
How about Big Pharma and depression? There are dozens of pharmaceuticals for depression, nearly all of them with side effects that include weight gain and suicidal ideation.
Psychedelics is represented there as well. Psilocybin has been found to be effective as a treatment for depression for up to one year, according to a recent Johns Hopkins study.
Meeting in the Middle
Big Pharma and the novel compounds represented by psychedelics are beginning to meet in the middle to figure out how they can work together. And psychedelics appear to be gaining ground, while Big Pharma carefully keeps tabs on the progress.
Don Drysdale, CEO of Cybin, speaking at the opening session of Wonderland 2022, said that he thinks that the most amazing thing about working in psychedelics is the research that is able to go from discovery to the bench to the clinic in about 18 months.
“Typically, with a Big Pharma model, that might take three to six years,” he said. “So one of the benefits of working with classic psychedelics like psilocybin and DMT and LSD is that we know a lot about these molecules. They’ve been around for decades. So we know a lot about their chemistry, their metabolism, their side effects, and that enables us to jump forward very quickly into clinical research.”
Christian Angermeyer, founder and chairman of Atai Life Sciences, also speaking at Wonderland 2022, said that there was “almost zero innovation” in mental health for the last 40 years.
“We were all using drugs like Xanax. And at the same time, though, over the last 10 or 15 years, the number of mental health patients and hence the burden on the health care system has gone up dramatically,” he said. “As an investor or an entrepreneur, I was like, ‘Oh my God, there’s this huge void, this mismatch of demand and the need for innovation.’”
Also at the psychedelics show, entrepreneur and futurist Zappy Zapolin talked about making psychedelic compounds look more like pharmaceutical drugs. “No matter what, even if a doctor thinks that psilocybin is definitely going to help you 100%, they don’t want to hand you a bag of mushrooms and say, I don’t know, maybe take like two caps and a stem,” he said. “They need pharmaceutical format. They need to know the half-life of the compound, for instance, and they need to know the targeted dosing.”
On stage with Zapolin was serial entrepreneur Kevin Harrington, known as one of the sharks in Shark Tank, who explained the reasoning for his recent investment in psychedelics: “When I heard about the mental health crisis in America, that there are north of 40% of people who have mental health issues, depression, anxiety, PTSD, addiction, and that there really is not a lot of great solutions,” he said. “I said, here are problems that are not being solved. So I researched and found out Psycheceuticals, which actually has patented delivery systems with targeted dosing without the psychedelic side effects.
“So that was very impressive to me, and very powerful. And this allows us to be able to work with children, and elderly, etc. It is definitely a mass market problem, and something that I like to focus on. So that’s why I got involved.”
Algernon Pharmaceuticals is working with a nonpsychedelic version of DMT to treat stroke, also hoping to appeal to Big Pharma. “What they want is data, data, data,” Christopher Moreau, CEO of Algernon, told Psychedealia.
Another example of how psychedelics is chasing Big Pharma is MindBio’s phase 1 clinical trial microdosing LSD to 80 healthy participants who take the drug at home in the same way that they would take any other medication.
“It’s good business to get the medicines where it needs to be with the patients,” Daniel Herrera, vice president of research and development for Braxia Scientific, said at the opening Wonderland presentation.
“And we also know that clinically speaking, mental health has a higher rate of lack of access to mental health care professionals, unlike cancer patients or cardiac patients. You have to bring the medicine and the therapies to them,” he said.
January 12, 2023 at 10:47 am
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