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Dr. Caroline Carney of Magellan Healthcare discusses the psychedelics in the pipeline for treating mental health conditions.
Mental health issues are common in the United States. Almost one in five people have a mental illness, according to the National Institute of Mental Health. Serious mental issues, including bipolar, major depressive disorder, schizophrenia, are those that impact a person’s life and ability to function.
One in 20 people experience serious mental health issues, and adolescents make up 22% of those with any mental disorder. About third of those with depression are treatment resistant, which leads to worse quality of life, higher comorbidity, increased disability and worse outcomes, and can result in increased use of healthcare resources.
Enter psychedelics, which have a long history of use but limited research of their safety and efficacy.
“As a clinician, I am excited about any opportunity we have to address the booming incidence of depression and anxiety disorders during and post-COVID-19. We need assistance for those people who don't respond to traditional antidepressants or who don't want to take traditional antidepressants. But I want to make sure that’s balanced against people self-medicating,” Caroline Carney, M.D., author of the paper and Magellan Healthcare’s president of behavioral health and chief medical officer of Magellan Health, said in an interview with FormularyWatch.
Magellan Rx Management, the PBM division of Magellan Health has released a clinical insights publication on the research of psychedelics for mental health conditions.
Several psychedelics, including MDMA and psilocybin, are making their way through the pipeline. But challenges exist because of the way that the U.S. Drug Enforcement Agency categorizes these drugs. They are considered Schedule I drugs, with the highest potential for abuse and the potential to create psychological or physical dependence.
“Because they're not legal for use, it’s very hard to do the research. You can't just bring the medications in and use them widely because of the legal status,” Carney said.
This, however, is starting to change. Medical marijuana and the approval of esketamine have begun to change the perception of psychedelics. Ketamine and esketamine are both Schedule III products, but Carney said they are considered psychedelics because of their hallucinogenic effects.
Janssen’s Spravato (esketamine) nasal spray was approved in March 2019, for treatment-resistant depression and then in August 2020 for major depressive symptoms with acute suicidal ideation. This is the first NMDA receptor antagonist to receive FDA approval for treatment-resistant depression, with a new delivery system via a nasal spray. It is available under a Risk Evaluation and Mitigation Strategy (REMS) program, because of the risk for serious adverse outcomes resulting from sedation and dissociation.
Spravato is expected to generate global sales of about $383 million by 2029, according to market research firm GlobalData. Although Spravato was a breakthrough treatment for acute suicidal ideation and behavior (ASIB), its high cost and requirement for two hours of patient observation after administration will limit its uptake, analysts at GlobalData predict.
At the state level, the State of Oregon in November 2020 passed legislation allowing for the sale of psilocybin products beginning in January 2023. This is the first state to do so. This will be implemented and regulated by a new division within the Oregon Health Authority, the Oregon Psilocybin Services Section. Currently, the state is working to develop a system to track products and licensing and compliance case. They are also working to develop processes and procedures.
“This will open up more research in the state,” Carney said. “It could also lead to other states following Oregon because it will be research dollars into universities and communities.”
The federal government also will have to consider this because ultimately, products will have to through the FDA for approval, she said. “When classed as a medication in a setting, with a REMS process, such as the one for esketamine, we will see a change in the view of the government from an illegal substance to a medication.”
These efforts could lead more biopharmaceutical companies to enter the psychedelic research space. At least one company, Mindset Pharma, has staked out a place in developing next-generation psychedelic medicines to treat neurological and psychiatric disorders. It is collaborating with the McQuade Center for Strategic Research and Development, an Otsuka company.
In January 2022, the two companies announced their collaboration, with McQuade providing a cash payment of $5 million to support the research of two families of a next-generation psilocybin and 5-MeO-DMT compounds through phase 1a and phase 1b trials.
Research of psilocybin, more commonly known as “magic mushrooms,” is also being done by academic centers, such as Johns Hopkins, which conducted a study of psilocybin in patients with major depressive disorder. The findings of this study, published February 15, 2022, suggest that there are antidepressant effects associated with psilocybin. This was a small study (27 patients) followed for 12 months.
“We believe more research needs to be conducted before we widely adopt the use of psilocybins,” Carney said. “The studies that we have seen are quite small. And they're not long term, so the longer-term risks and effectiveness are not well known."
Closest to approval is therapeutic MDMA, commonly known as ecstasy, which could be available in 2023. The Multidisciplinary Association for Psychedelics Studies (MAPS) is leading the phase 3 research of MDMA for the treatment of PTSD. Two studies, MAPP1 and MAPP2, are assessing the safety and efficacy of MDMA therapy in 200 to 300 patients with severe PTSD from any cause in those 18 and older.
If approved, Carney said, insurance could cover this medication as part of a step-therapy program. “But there would have to be enough evidence for any approved product to be considered outside the realm of investigational or experimental.”