psychedelics Archives - Medical Design Sourcing

FDA grants breakthrough status to LSD-based anxiety treatment

In a major shift away from decades of stigma, the FDA has granted Breakthrough Therapy Designation to MindMed‘s MM120, an LSD-based treatment for Generalized Anxiety Disorder (GAD). This milestone not only underscores the growing recognition of the therapeutic potential of psychedelics but also could point to a potential turning point for the struggling psychedelic sector and specifically bolsters the future of MindMed.

[Related: Could LSD change the game in anxiety treatment?]

Psychedelic stocks: A long, strange trip continues

As with many psychedelic companies, MindMed’s stock (NASDAQ: MNMD) has been on a rollercoaster ride in recent years, briefly reaching close to $60 per share in early and mid-2021 amid peaking investor enthusiasm for the potential of psychedelic-based treatments. But the stock, like many others in the sector, has faced significant declines as investor enthusiasm waned later in 2021 and 2022.

The breakthrough therapy des…

LSD shows promise as standalone anxiety treatment in trial

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Phase 2b data from MindMed’s LSD-based therapy adds to the mounting evidence that psychedelic-assisted therapies could treat mental health conditions like anxiety, depression and PTSD.

In particular, the study found statistically significant dose-dependent improvements in the Hamilton Anxiety rating scale (HAM-A) at the 100 and 200 μg dose levels in the four-week study. Similarly, recent phase 2 Cybin data found 79% remission for depression after two doses of its psilocybin-based therapy. And MAPS filed for MDMA approval in PTSD based on phase 3 results.

But MindMed’s study was unique in its evaluation of MM-120 as a standalone single-dose oral medication without psychotherapy. The compound, an LSD tartrate formulation, showed clinically and statistically significant reductions in anxiety symptoms over four weeks when given as a single monotherapy dose in patients with generalized an…

The psychedelic neuroplasticity and safety conundrum: Reaping the rewards of neuroplasticity with caution

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Evidence continues to build that serotonergic psychedelics such as psilocybin, DMT, and LSD promote neuroplasticity. Cortical atrophy is involved in the development of a broad swathe of neuropsychiatric conditions ranging from depression to substance use disorder. But it remains unclear how psychedelics may potentially treat mood disorders and other conditions. Despite their therapeutic potential, these compounds continue to remain unpopular in some quarters and could be contraindicated for many individuals even if they ultimately win regulatory approval.

Drug developers, such as Boston-based Delix Therapeutics and Onsero Therapeutics, aim to develop compounds that trigger neuroplasticity in what they deem to be a safer and more accessible therapeutic option than classic psychedelics.

Meanwhile, players such as Compass Pathways (Nasdaq:CMPS) and Small Pharma (CVE:DMT), are wo…

5 headwinds and 5 tailwinds for psychedelic medicine

Psychedelics were featured at SXSW 2022. [Image courtesy of Wikimedia Commons]

Decades after compounds like LSD and psilocybin were made illegal , psychedelic medicine appears poised to go mainstream in the coming years, potentially treating conditions ranging from anxiety to PTSD.

In the interim, however, hurdles remain.

The American Psychiatry Association (APA) recently released a conservative position statement on psychedelics and empathogens such as MDMA. In essence, the organization concluded that psychedelic medicine remains at the clinical stage. At present, there is “inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies,” APA noted.

While the APA said it supports rigorous clinical research into the compounds, “clinical treatments should be determined by scientific…

Can the U.S. unify around psychedelics for mental health?

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The U.S. has perhaps never been more divided than it is today. Americans are divided over politics and myriad social issues, COVID-19, climate change, immigration and seemingly everything else.

Not surprisingly, opinions also diverge on whether psychedelic drugs have therapeutic potential. Earlier this year, a survey from The Harris Poll found that 65% of Americans with anxiety, depression or PTSD believe that drugs such as the classic psychedelic psilocybin and the empathogen methylenedioxymethamphetamine (MDMA) should be available for therapeutic use. The compounds remain Schedule I drugs but could find FDA approval in the coming years.

Mental health professionals have tended to view psychedelics skeptically after they were illegal in the 1970s. A 2018 survey in The Journal of Nervous and Mental Disease found that psychiatrists tended to view psychedelics as “potent…

How psychedelics could address unmet need in mental health

[Image courtesy of Pixabay]Interest in the therapeutic potential of psychedelics is booming, given their therapeutic potential for treating depression and other conditions. It is telling that psychedelics were among the hottest topics at the World Economic Forum (WEF) meeting this year in Davos, Switzerland, prompting mockery from late-night comics.

Although the field remains embryonic, part of the reason for the recent interest in psychedelics is their potential to address difficult-to-treat mental health conditions.

Get the full story from our sister site, Drug Discovery & Development.

How psychedelics could address unmet need in mental health

[Image courtesy of Pixabay]

Interest in the therapeutic potential of psychedelics is booming, given their therapeutic potential for treating depression and other conditions. It is telling that psychedelics were among the hottest topics at the World Economic Forum (WEF) meeting this year in Davos, Switzerland, prompting mockery from late-night comics.

Although the field remains embryonic, part of the reason for the recent interest in psychedelics is their potential to address difficult-to-treat mental health conditions. For example, research such as the U.S. government-backed Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study “showed us that our available medications are not as effective as we’d hoped they would be,” said Dr. John Krystal, chair of the department of psychiatry at Yale University, in a recent webinar from Cybin (Toronto, Canada). For depressed who respond to s…

Clearmind aims to use a psychedelic to treat alcoholism

The psychoactive compound 5-methoxy-2-aminoindane (MEAI) is unique among psychedelics with therapeutic potential. First, the drug could be self-administered. Second, it is patented, unlike psychedelics such as LSD, psilocybin, MDMA and ketamine. And while psychedelic drug developers tend to focus on indications such as depression, anxiety and post-traumatic stress disorder, MEAI could potentially treat alcoholism. MEAI was first described in 1980 as a non-hallucinogenic recreational drug. Early users of it claimed it reduced their desire to drink. “It is an unusual situation where you have human testimonies, and now we’re going back to animals,” said Adi Zuloff-Shani, CEO of Clearmind Medicine, the developer of the drug. MEAI has “great potential to help with one of the most devastating addictions society knows today, which is alcoholism,” Zuloff-Shani said. Like a number of other psychedelics companies, Clearmind Medicine is headquartered in Vancouver, Cana…

What the ketamine boom could mean for pharma

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The demand for ketamine has surged in recent years as interest in its off-label use for treating depression, anxiety and PTSD has grown.

Ketamine has been “shown to be very effective,” said Linnea Butler, founder and CEO of Bay Area Mental Health (Campbell, California), which recently began offering ketamine-assisted psychotherapy.

Also this week, Earlier this week, Pasithea Therapeutics Corp. (NSDQ:KTTA), announced the launch of the first U.K.-based ketamine infusion clinic.

And separately, Delic Holdings (CSE: DELC) announced two new alliances between Ketamine Wellness Centers (KWC) and the Veterans Administration Community Care Networks of Illinois and Minnesota. KWC plans to provide ketamine for PTSD, depression and chronic pain to veterans at no out-of-pocket cost at their locations in Naperville, Illinois, and Burnsville, Minnesota.

Parke-Davis, now …

PurMinds believes psychedelics hold promise for neurological conditions

Interest in psychedelics has ratched up in recent years and a growing number of drug companies are beginning to explore their potential to treat everything from depression to neurodegeneration.

“It is a really really exciting time,” said Aron Buchman, chief strategy officer, PurMinds BioPharma, which is exploring psychedelics’ potential to treat neurological diseases.

American author Michael Pollan recently surmised in an interview with Independent that the psychedelics industry was in a “gold rush” phase. “Whether it’s going to work is another question. I think it’s going to be very challenging to fit into the system,” Pollan added.

Headquartered in North York, Ontario, PurMinds is based in a country that is warming up to the therapeutic potential of psychedelics. The Canadian government has granted a number of patients a federal dispensation covering the therapeutic use of p…

The backstory on PurMinds’ investment in Israeli psychedelic drug company IMIO Life

Privately-held PurMinds BioPharma (Burlington, Ontario, Canada) recently announced an investment in the psychedelic drug company IMIO Life Ltd., a subsidiary of Tel Aviv–based Nextage Therapeutics Ltd. (TASE:NXTG). Nextage Therapeutics is itself a division of the pharmaceutical company Nextar Chempharma Solutions (Ness Ziona, Israel).

We reached out to PurMinds’ chief strategy and financial officer, Aron Buchman, to learn more about the alliance.

PPW: How did the relationship between PurMinds and IMIO Life come about?

Aron Buchman: PurMinds and the Nextar Family have had a corporate relationship since 2019. The initial R&D focus was on PurMinds’ patented nano-extraction technology.

PurMinds CEO Janet Qi visited Nextar Chempharma at their ODEC-accredited facilities at the prestigious Weizman Science Park, Israel. Unfortunately, the collaboration between the Nextar family of companies and the PurMinds family of companies was hindered by the COVI…

Debate series considers the promise and pitfalls of psychedelics

Photo by Sergey Katyshkin from Pexels

Intelligence Squared, the organizers of a popular debate series, recently asked a panel of experts whether psychedelics should be legalized. There was considerable overlap between the factions arguing in favor and opposition of that motion, reflecting the growing interest in psychedelic compounds for therapeutic applications. But the two camps were split when it came to the best regulatory model for psychedelic drugs.

“I advocate strongly that [psychedelics] be allowed to be studied for medical research to see what their therapeutic indications are and how they can help us to understand the brain and the mind,” said Dr. Jeffrey Lieberman, the chair of Columbia University’s department, who argued against the motion.

Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), argued for a more permissive approach that would a…