European Pharmaceutical Review

JULY 19, 2023

Phase II study results for navacaprant (NMRA-140), a novel kappa opioid receptor (KOR) antagonist for major depressive disorder (MDD) demonstrated significant and clinically meaningful improvement in depression for participants. When it first commenced, the clinical trial enrolled only mild-to-moderate MDD US patients.

Pharmacology 95

Pharmacology Patients Safety Medicine 95

European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). “Exxua is the first 5-HT1a agonist with superior efficacy versus placebo as MDD monotherapy, yet did not differ from placebo in rates of sexual dysfunction in clinical trials.

FDA 93

FDA Food and Drug Administration Medicine Food 93

MedCity News

NOVEMBER 4, 2022

Lusaris Therapeutics launched with $60 million for clinical development of a psychedelic depression drug it claims will be easier to dose and fast-acting. The company was formed and incubated by RA Capital Management, which led the startup’s Series A round of financing.

Management 103

Management Biopharma Pharma 103

European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper. At day 45, 61.9

Food and Drug Administration 90

Food and Drug Administration Food Safety FDA 90

European Pharmaceutical Review

NOVEMBER 4, 2022

A new report in the New England Journal of Medicine for the largest-ever trial observing the effects of psilocybin in patients with treatment-resistant depression, found participants reported reduced depressive symptoms three weeks after being given 25mg of psilocybin (COMP360) in combination with psychological support.

Patients 96

Patients Medicine Medical Pharmaceutical 96

Pharmacy Times

MARCH 27, 2024

Psychedelic medicines such as psilocybin, MDMA, ketamine, and LSD have been shown to have a significant impact on conditions such as major depressive disorder, generalized anxiety disorder, and post-traumatic stress disorder in clinical trials.

Medicine 59

Medicine 59

European Pharmaceutical Review

SEPTEMBER 20, 2022

New data supports the potential use of Biogen’s and Sage Therapeutics’ zuranolone as a potential episodic treatment for people with major depressive disorder (MDD). Zuranolone is an investigational oral 14-day treatment under clinical development for adult patients with MDD and postpartum depression.

Safety 88

Safety Patients Leads Pharmaceutical 88

Pharmaceutical Technology

JANUARY 4, 2024

SP-624 is under clinical development by Sirtsei Pharmaceuticals and currently in Phase II for Major Depressive Disorder.

Pharmaceutical 75

Pharmaceutical 75

European Pharmaceutical Review

JUNE 28, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a first-of-its-kind trial to run this year to test psychedelic drugs as a treatment for major depressive disorder (MDD). The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy.

Ethics 77

Ethics Medicine Pharma FDA 77

Pharmacy Times

NOVEMBER 8, 2022

With many different classes of medications used in the treatment of major depressive disorder, pharmacists can have a significant impact on patients' lives, from counseling on medications to assisting with finding the right medication.

Medical 52

Medical Patients 52

Pharmacy Times

MARCH 14, 2024

At 4 months, 75% of participants achieved remission and no longer showed signs of depression symptoms in a phase 2 clinical trial.

FDA 59

FDA 59

Legacy MEDSearch

JULY 24, 2023

We are very pleased to announce the start of the OLO clinical trial with SAINT therapy for people with MDD who are ineffectively treated by prior antidepressant medications,” said Brandon Bentzley, M.D., Our clinic specializes in caring for the hardest and most hopeless, depressed patients by providing the best treatments available.

Medical 52

Medical Recruitment FDA Specialization 52

World of DTC Marketing

JUNE 29, 2022

Clinics offering debunked cancer treatments are still advertising on Facebook despite the company’s efforts to control medical misinformation. Every time in a while, I see a post on my Twitter feed for Opdivo or drugs to treat depression. Why ANY pharma marketer would think someone would click on the ad is beyond me.

Media 228

Media Patients Pharma Medical 228

World of DTC Marketing

FEBRUARY 8, 2022

According to the Lancet, a medical journal, the incidence of depression and anxiety has soared in the pandemic—by more than 25% globally in 2020. The product is marketed as clinically validated based on a scientific study that concluded that humans could form meaningful bonds with bots. But are they safe and effective?

Marketing 241

Marketing Doctors Medical Patients 241

Pharmaceutical Technology

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has granted approval for AbbVie ’s Vraylar (cariprazine) as an adjunctive treatment to antidepressants to treat adult patients with major depressive disorder (MDD). The latest approval is based on clinical findings showing efficacy and well-established tolerability of this therapy.

Food and Drug Administration 59

Food and Drug Administration FDA Food Medical 59

Pharmaceutical Technology

FEBRUARY 20, 2024

Ketamine is under clinical development by NRX Pharmaceuticals and currently in Phase III for Bipolar Disorder (Manic Depression).

Pharmaceutical 40

Pharmaceutical 40

Pharmaceutical Technology

FEBRUARY 19, 2024

Ketamine is under clinical development by NRX Pharmaceuticals and currently in Phase III for Bipolar Disorder (Manic Depression).

Pharmaceutical 40

Pharmaceutical 40

Pharmaceutical Technology

FEBRUARY 21, 2024

Psilocybin is under clinical development by Filament Health and currently in Phase I for Treatment Resistant Depression.

40

40

European Pharmaceutical Review

DECEMBER 21, 2022

The potential of tryptamines in treatment-resistant depression. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial. mRNA therapeutics: a limitless revolution in medicine.

Medicine 80

Medicine Medical Pharmaceutical 80

European Pharmaceutical Review

NOVEMBER 28, 2022

The comparative, randomised, open-label clinical trial evaluated the drug’s short- and long-term efficacy, safety and tolerability. ESCAPE-TRD clinical trial assessing SPRAVATO ® for treatment-resistant major depressive disorder. The most common (?10 percent), nausea (29.3 percent), dissociation (28.1 percent), headache (24.6

Safety 86

Safety Patients Medicine Pharmaceutical 86

Pharmacy Times

JANUARY 4, 2023

The benefits of physical activity may be greater for children and adolescents with clinical depression or depressive symptoms, who may develop anxiety and other disorders in adulthood.

55

55

Pharmaceutical Technology

JANUARY 22, 2024

Repurposed Drugs is under clinical development by Luminous Mind and currently in Phase I for Depression.

40

40

Pharmaceutical Technology

JANUARY 22, 2024

Repurposed Drugs is under clinical development by Luminous Mind and currently in Phase I for Depression.

40

40

World of DTC Marketing

MAY 24, 2022

Mental health apps claim to treat depression, anxiety, and other mental illnesses without therapy appointments. Another app cautioned that “sometimes bipolar disorder can transfer to another relative if they spend too much time with you and listen to your depressive life.”. Mental wellness apps are basically the Wild West of therapy.

Patients 252

Patients Prescription Medical Marketing 252

Pharmaceutical Technology

NOVEMBER 5, 2023

ALTO-300 is under clinical development by Alto Neuroscience and currently in Phase II for Major Depressive Disorder.

40

40

European Pharmaceutical Review

DECEMBER 8, 2023

Cerevel’s pipeline includes multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson’s disease, and mood disorders. CVL-354, a kappa opioid receptor (KOR) antagonist that is currently in Phase I trials for treatment of major depressive disorder (MDD).

Safety 95

Safety FDA Management Pharmaceutical 95

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

Food and Drug Administration 85

Food and Drug Administration Prescription Media FDA 85

Pharmaceutical Technology

NOVEMBER 29, 2022

For several decades, researchers have been investigating the role of ketamine in treating depression. Since then, ketamine-assisted psychotherapy has become increasingly prominent, and is often used off label to treat certain kinds of depression. Depression research spurs efforts for other conditions.

Side effects 110

Side effects Pharmaceutical Patients Medicine 110

pharmaphorum

DECEMBER 19, 2022

AbbVie has secured its fourth FDA approval for Vraylar, adding adjunctive therapy of major depressive disorder (MDD) to a list that includes schizophrenia and manic and depressive episodes in bipolar disorder. The FDA’s decision comes despite mixed results in clinical trials of the drug as an adjunctive treatment for depression.

FDA 52

FDA Marketing Competition Sales 52

Legacy MEDSearch

SEPTEMBER 6, 2022

Food & Drug Administration (FDA) for the SAINT TM Neuromodulation System for the treatment of major depressive disorder (MDD) in adults who have failed to achieve satisfactory improvement from prior antidepressant medications in the current episode. This clearance expands the way we can use TMS to treat depression. George, M.D.,

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

Patients 52

Patients Food and Drug Administration FDA Safety 52

pharmaphorum

SEPTEMBER 23, 2022

On Tuesday, Curebase announced a three-year clinical trial partnership with Meru Health, the study looking at the effectiveness of the latter’s 12-week treatment program, developed to reduce depression in primary care patients.

Recruitment 59

Recruitment Patients Electronics Doctors 59

Pharmaceutical Technology

JUNE 6, 2023

Lotus Pharmaceuticals, NRx Pharmaceuticals and Alvogen have entered a global collaboration deal to develop and commercialise NRX-101 for suicidal treatment-resistant bipolar depression (S-TRBD). Lotus will purchase global rights for NRX-101 and handle the commercialisation activities of the product in markets outside the US.

Food and Drug Administration 52

Food and Drug Administration Sales FDA Food 52

European Pharmaceutical Review

DECEMBER 15, 2022

The primary endpoint in both trials evaluated the proportion of patients with clinically meaningful improvement in itch from baseline (measured by a ≥4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] on a 0-10 scale) at 24 and 12 weeks, respectively. Phase III trial data that formed the basis of the EC’s approval.

Medicine 83

Medicine Safety Side effects Patients 83

PM360

MAY 25, 2023

Currently, OM1 can harness real-world data from clinical notes obtained from more than 9,000 clinicians working in 2,500 clinics across all 50 states, and the company recently added data from more than 148,000 patients with schizophrenia and bipolar this past March.

Side effects 95

Side effects Medical Patients Networking 95

European Pharmaceutical Review

DECEMBER 21, 2022

Fluoxetine was approved to treat depression 35 years ago. Since then, there have been few breakthrough innovations in treating neuropsychiatric diseases such as anxiety, depression, substance use disorders (SUDs), and post-traumatic stress disorder (PTSD). For many indications, progress has been incremental.

Food and Drug Administration 110

Food and Drug Administration Medicine Food Government 110

pharmaphorum

SEPTEMBER 14, 2022

Vocal patterns are also starting to attract attention as potential diagnostic tools for conditions, including post-traumatic stress disorder (PTSD), depression, and stress. The NIH-backed voice project hopes to develop AIs that can be used to “empower doctors with a low-cost diagnostic tool to be used alongside other clinical methods.”

Ethics 100

Ethics Doctors Training Medical 100