mental health Archives - Medical Design Sourcing

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…

50 of the best-funded biotechs of 2023

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As the year draws to a close, it is clear that molecular science and diagnostics is the hottest funding area in the biotech industry. In an analysis of 50 of the best-funded biotechs of 2023 focused on human health, molecular and science and diagnostics startups collectively attracting roughly $945 million, dwarfing the figures in other segments. The next popular two niches, gene therapies and oncology, had average funding levels of approximately $245 million and $170 million, respectively. While AI has received a significant amount of attention this year, biotechs specializing in that field garnered an average funding of only about $66 million. Outside of the life sciences, startups with a broader focus on AI raised a cumulative average of $202.47 million, based on an analysis of close to 1000 companies.

Caris Life Sciences has raised nearly $1.7B to date

In terms of best-funded companies overall,…

At Day 21, low-dose ketamine KET01 shows no statistical edge over placebo.

Ketabon GmbH revealed positive top-line results from its phase 2 KET01-02 study investigating KET01, an oral slow-release formulation of oral ketamine, for treatment-resistant depression (TRD). Results were promising initially. Investigators noted improvements in depression severity as early as day 4, but data were not statistically significant over placebo at day 21.

A look at Ketabon GmbH’s KET01-02 study in treatment-resistant depression

The trial studied KET01 doses of 120 mg and 240 mg per day. It involved 122 individuals who were outpatients with current major depressive episodes not responding to at least two standard antidepressants. Participants received KET01 once daily in addition to a traditional antidepressant treatment over the three-week period. In particular, the 240 mg/day dose showed clinically relevant improvements with statistical significance versus placebo on days 4 and 7. The drug, however, did not maintain significance at day 21.

K…

Rethinking treatment options for patients diagnosed with bipolar 1 disorder

The COVID-19 pandemic has contributed to a significant increase in the rates of Americans living with mental illness.1 Meanwhile, medication shortages and a chronic scarcity of mental health professionals added pressure to an already stressed system.2 In this context, pharma companies play a vital role in developing novel therapies for mental health conditions, which can help alleviate the burden on healthcare providers and improve patient outcomes. As a clinical nurse practitioner who treats patients with a variety of mental health conditions, including bipolar 1 disorder, I believe innovative mental health strategies and treatment options, such as Lybalvi for bipolar 1 disorder, need to be considered across the healthcare spectrum.

Bipolar 1 treatment challenges

It is common for patients living with bipolar 1 disorder to be misdiagnosed with, and receive treatment for, major depressive disorder. Furthermore, up to one-third of patients can remain misdiagnosed for te…

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…

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…