Serotonin

Supernus Pharmaceuticals' SPN-820 showed rapid and substantial effects in a Phase IIa trial for major depressive disorder, with a clinically meaningful improvement on the HAM-D6 scale and a significant reduction in suicidal ideation. SPN-820 is designed as a rapid-acting treatment, contrasting with the slower effects of SSRIs, and is well-tolerated with common AEs like headache and nausea. A Phase IIb study is ongoing, with results expected in H1 2025.

Ms June, 62, with severe, recurrent MDD, inquires about rTMS efficacy. Studies show 40% pooled response in trials, 31% in clinical settings. A recent analysis identified rapid responders by week 2. Winninge et al found early improvements in initiative, emotional involvement, and overall MADRS-S score predict rTMS response, with longer depressive episodes and previous ECT linked to lower odds of response. Clinical factors and early symptom improvements are key predictors for rTMS efficacy in depression.

The article discusses psilocybin's classification, therapeutic potential, and varying state laws. It highlights the growing interest in psychedelics for treating conditions like depression and PTSD. The article also addresses the legality of microdosing psilocybin, noting its federal illegality but varying state and local enforcement priorities. It provides examples of cities in California that have made psilocybin use a low enforcement priority. The article concludes with recommendations for employers dealing with employees microdosing at work, emphasizing the importance of clear policies and a safe workplace.

A European study suggests 'magic' mushrooms, specifically psilocybin, are more effective at treating depression than conventional SSRIs, with rapid and lasting benefits. Psilocybin, granted 'breakthrough therapy' status by the FDA, may rewire the brain, offering relief to those with treatment-resistant depression. Challenges include stigma, cost, and the need for supervised administration.

U.S. Customs and Border Patrol seized 15 shipments of psilocybin-laced chocolate bricks over 30 days at the Port of Buffalo. Psilocybin, a Schedule 1 controlled substance, is not a narcotic but is being studied for potential therapeutic benefits in depression treatment.

Despite expert calls for recognition of complex PTSD, DSM-5-TR lacks formal diagnosis, impacting clinical understanding and treatment. Historical context reveals evolving awareness of trauma's effects, from Freud's retracted seduction theory to Vietnam War veterans' activism. DSM-III introduced PTSD in 1980, but its nonspecificity led to calls for nuanced diagnoses like complex PTSD. Field trials in the 1990s supported a new diagnosis, but it was ignored. Today, progress in nonpharmacological treatments exists, yet complex PTSD remains unrecognized, affecting FDA decisions on treatments like MDMA-assisted psychotherapy.

The article discusses psilocybin's therapeutic potential, state laws on its use, and employer responses to employee microdosing. It highlights federal illegality under the Controlled Substances Act, contrasting with state-level decriminalization efforts. Employers are advised to clarify drug use policies, offer employee assistance programs, and ensure safety in safety-sensitive roles.

FDA grants Fast Track designation to Denovo Biopharma's DB104 (liafensine) for treatment-resistant depression (TRD), recognizing its potential to address an unmet medical need. Liafensine, a first-in-class triple reuptake inhibitor, demonstrated efficacy and favorable safety profile in the ENLIGHTEN clinical trial, guided by Denovo's novel pharmacogenomic biomarker, DGM4™.

15 participants (5 females, 10 males) showed varying degrees of urinary protein reduction post-treatment; 6 with >50% decrease, 9 with <50%. Mean 24-h urinary protein quantification pre-enrollment was 1.15 ± 0.94 g/day. Gastrointestinal symptoms improved in all post-treatment. 24-h urinary protein quantification decreased significantly at 1 and 3 months post-FMT, excluding 2 with acute infections. Specific urinary proteins and most immune cells/cytokines showed no significant changes. B cell counts decreased significantly post-FMT. Safety indicators showed no significant changes except for serum sodium and calcium. No severe adverse events reported. Gut microbiota composition changed post-FMT, with correlations noted between specific bacteria and B cell changes. Intestinal metabolite composition also changed, with correlations found between specific metabolites and B cells, serum calcium, and sodium.

BMS’s new schizophrenia drug Cobenfy, approved by FDA, offers a unique treatment option but won’t see significant acceleration until mid-next year. Success hinges on market access and indication expansion.