Pharmacist Digest

Large network of clinics offering ketamine for depression shuts down

STAT

MARCH 16, 2023

One of the largest operators of ketamine clinics in the country abruptly closed its facilities this week, leaving patients in the dark and out of treatment for depression and other chronic conditions. Interest in ketamine to treat depression and other conditions has grown in recent years.

Sleep Or Depression? Trazodone’s Dose Dependent Clinical Response

Med Ed 101

APRIL 17, 2024

Although trazodone is only FDA-approved for the treatment of major depressive disorder (MDD), it is most often used off-label to manage insomnia. What’s interesting about trazodone is the drug’s wide dosing range – with lower doses (25-150 mg) effectively managing insomnia […] The post Sleep Or Depression?

Labelling

STAT+: Intra-Cellular reports positive results in depression study aimed at expanding use of antipsychotic medicine

STAT

APRIL 16, 2024

Intra-Cellular Therapies reported positive results Tuesday from a late-stage clinical trial seeking to expand the use of its antipsychotic medicine Caplyta to patients with major depressive disorder. In the Phase 3 study, Caplyta reduced depressive symptoms by 4.9

Drug Development

Opinion: What antidepressants are saying 30 years after the publication of ‘Listening to Prozac’

STAT

NOVEMBER 16, 2023

In 1993, I published “Listening to Prozac,” a book that grew out of my clinical experience prescribing what was then a new class of medications, ones thought to moderate depression through their effect on the way that the brain handles the neurotransmitter serotonin.

Opinion: As a rule, rape exceptions for abortion don’t work

STAT

APRIL 9, 2024

Wade in 2022, Texas implemented Senate Bill 8 , which banned abortions for all but the very few who made it to a clinic within about two weeks of missing their period. I was an abortion provider at the time in San Antonio, and the eight months I worked after SB8 took effect were the most depressing of my career.

STAT+: Relmada antidepressant drug fails first of several late-stage clinical trials

STAT

OCTOBER 13, 2022

Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinical trial, a significant setback for the company’s only medicine in clinical development. Continue to STAT+ to read the full story…

STAT+: FDA approves Sage Therapeutics’ rapid-acting medication for postpartum depression but not major depression

STAT

AUGUST 4, 2023

The Food and Drug Administration on Friday approved a new, rapid-acting medicine made by Sage Therapeutics to treat postpartum depression, the first oral treatment for the condition. But the agency denied the company’s application for an indication for major depression, a much larger potential market.

Labelling

Mind-altering ketamine becomes latest pain treatment, despite little research or regulation

STAT

NOVEMBER 7, 2023

Prescriptions for ketamine have soared in recent years, driven by for-profit clinics and telehealth services offering the medication as a treatment for pain, depression, anxiety and other conditions. WASHINGTON (AP) — As U.S.

They’re immigrants, farmworkers, and new moms. And they’re facing postpartum depression at higher rates

STAT

SEPTEMBER 13, 2023

Over more than a decade working with immigrant farmworkers in the public clinics of the Santa Clara River Valley, Rosemary Hernandez has seen many new moms struggle during the postpartum period. Their isolation and vulnerability compounded the challenges of caring for a newborn, and drove many of these mothers into anxiety and depression.

Compounding

STAT+: Flow Neuroscience shows promising results in trial of brain-stimulation headset for depression

STAT

JULY 31, 2023

Flow Neuroscience, a small Swedish company treating depression with brain-stimulating headsets, released early data on Monday showing that its device relieved depressive symptoms in clinical trials. The company has not yet formally written up the data for a journal.

STAT+: FDA’s Woodcock, other experts highlight persistent issues plaguing pharma, biotech in the wake of Covid-19

STAT

NOVEMBER 7, 2023

WASHINGTON — Current and former government officials proffered a clear-eyed, and often depressing, take Tuesday on the state of clinical trials, the pharmaceutical industry, and biotech investors coming out of the Covid-19 pandemic.

Vaccines

STAT+: With new study data, Intra-Cellular could expand use of approved mood-disorder treatment

STAT

MARCH 28, 2023

Intra-Cellular Therapies, maker of an approved treatment for schizophrenia and bipolar depression, announced positive results from a new clinical trial on Tuesday that could potentially expand use of its drug to other types of mood disorders. Sales of the Intra-Cellular drug, called Caplyta, tripled last year to $249 million.

Telehealth startups prescribing ketamine at home are stirring concern

STAT

NOVEMBER 3, 2022

Since the late ’90s, Kathy Wallace has been battling major depression with a series of drugs — first Prozac, then three others, and back again to Prozac. When the 53-year-old researched nearby clinics, though, she found them out of reach. But in the last six months, nothing seemed to be helping.

Labelling

STAT+: Pharmalittle: FDA OKs Sage drug for postpartum depression; major U.S. health systems to offer Alzheimer’s drug

STAT

AUGUST 7, 2023

Food and Drug Administration approved a new, rapid-acting medicine made by Sage Therapeutics to treat postpartum depression, the first oral treatment for the condition , STAT writes. But the agency rejected an indication for major depression, a much larger potential market. Analysts noted major depression is a much larger market.

Mayo Clinic

STAT+: Pharmalittle: We’re reading about Lilly’s Zepbound for sleep apnea, the FDA budget, and more

STAT

APRIL 17, 2024

health regulator last year approved the company’s and partner Biogen’s pill Zurzuvae as a treatment for postpartum depression, but rejected it for clinical depression, which is a much larger market. The failure is the latest hurdle for Sage Therapeutics after the U.S.

Why depression after traumatic brain injury is distinct — and less likely to respond to standard treatment

STAT

JULY 6, 2023

Traumatic brain injury multiplies the risk of major depression eightfold. While the emotional trauma of whatever caused such deep damage may be understandable, from a blast in a war zone to a blow on the playing field, there’s a physiological component, too, that neuroscientists have long suspected but have been unable to identify.

Medical Schools

Medical Schools Hospitals

STAT+: Sage hopes for a blockbuster in fast-acting antidepressant now before FDA

STAT

JULY 31, 2023

Cheryl Meier had watched clinical trial enrollment announcements for years — but always for her sons’ type 1 diabetes, never for herself. But it never worked for her dark thoughts.

Diabetes

STAT+: Ketamine clinics’ bust serves as warning of business challenge facing psychedelic therapy

STAT

MAY 16, 2023

A chain of luxury ketamine clinics called Field Trip started churning through business strategies at an increasingly rapid pace late last year. The money was running out, clinics were half full, and the company’s vice president of clinical services was under intense pressure to launch an at-home ketamine service.

STAT+: Big Health acquires Limbix, maker of mental health app for depression in adolescents

STAT

JULY 14, 2023

Big Health, one of the leading companies producing apps to help treat mental health conditions, on Thursday announced it acquired Limbix, developer of a prescription app for adolescent depression. Developers of prescription digital therapeutics , in particular, have been reeling. Continue to STAT+ to read the full story…

‘I’m terrified’: Patients scramble for treatment after 13 ketamine clinics shut down

STAT

MARCH 17, 2023

The message went out to some patients and to all of the employees of his company’s clinics across nine states — what had, up until moments before, been one of the largest ketamine clinic chains in the country. To patients, the news came as a complete shock. To patients, the news came as a complete shock.

STAT+: Male birth control gets another shot with small new trial of non-hormonal pill

STAT

DECEMBER 13, 2023

One man in the trial developed severe depression and another attempted suicide, developments that have been recorded , but are not typical for, women on birth control pills. The pill entered its Phase 1 clinical trial today in the U.K., Continue to STAT+ to read the full story…

When young people survive cancer, their mental-health struggles are often just beginning

STAT

JUNE 28, 2023

The meta-analysis of 52 clinical studies measured the prevalence and severity of psychological disorders in over 20,000 young cancer survivors. But the trauma that patients experience as they deal with the disease can pose a lifelong risk to their mental health, according to a recent analysis published in JAMA Pediatrics.

Cybin bags breakthrough tag for psychedelic depression drug

pharmaphorum

MARCH 14, 2024

Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.

Exercise ‘may be better than drugs for depression’

pharmaphorum

FEBRUARY 15, 2024

Exercise matched psychotherapy and was more effective than medication as a treatment for #depression in a meta-analysis of randomised clinical trials

High ADHD comorbidity rates offer opportunity for pipeline products to capture market: GlobalData

Express Pharma

MARCH 4, 2024

Attention-deficit/hyperactivity disorder (ADHD) is a clinically heterogenous neurodevelopmental disorder with high rates of comorbidity with other childhood-onset psychiatric disorders as well as learning disorders. For the adult ADHD population, this was followed by the rate of comorbid depression at 27.8 per cent and 28.3

As psychedelics near approval, there’s no consensus on how they work

STAT

JULY 3, 2023

DENVER — The founder of Field Trip , a chain of shuttered ketamine clinics currently facing insolvency, put forward an unexpected theory of how psychedelics work to treat depression last month.

Depression now one of the top five most studied disease areas in clinical development, finds Phesi

Outsourcing Pharma

JULY 24, 2023

Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

STAT+: Pharmalittle: We’re reading about a failed schizophrenia drug trial, a Pfizer cancer drug, and more

STAT

MARCH 12, 2024

… Acadia Pharmaceuticals disclosed that its approved medicine called Nuplazid failed to improve the social and emotional symptoms of schizophrenia in a late-stage clinical trial , STAT tells us. The company does not intend to conduct any further clinical trials with Nuplazid. We enjoy the feedback.

Call for volunteers to test ground-breaking psychedelic treatments for mental health conditions

Outsourcing Pharma

NOVEMBER 28, 2023

Volunteers with conditions including depression, alcohol use disorder, and anorexia are being sought by Clerkenwell Health, to join its seminal clinical trials.

STAT+: J&J wins a partial appeal against the U.K.’s cost-effectiveness watchdog over ‘unfair’ review

STAT

SEPTEMBER 9, 2022

’s cost effectiveness watchdog agency acted unfairly and exceeded its authority by failing to thoroughly explain why it declined to recommend a Johnson & Johnson medicine called Spravato for combating treatment-resistant depression.

Drug Pricing

STAT+: Telehealth companies that prescribed controlled substances during the pandemic brace for business to change

STAT

NOVEMBER 11, 2022

The public health emergency paved the way for these young companies — whose prescriptions range from ADHD medication to substance use disorder treatment and off-label ketamine for depression — to prescribe medicines without ever seeing a patient in-person. Continue to STAT+ to read the full story…

Controlled Substances

Controlled Substances Labelling

First oral medicine for postpartum depression approved

European Pharmaceutical Review

AUGUST 7, 2023

The US Food and Drug Administration ( FDA ) has approved Zurzuvae ( zuranolone ), the first oral medicine to treat postpartum depression (PPD) in adults. FDA approval of Zurzuvae for postpartum depression was granted to Sage Therapeutics, Inc. Historically, treatment for PPD has been only available as an IV injection.

Curebase and Flow Neuroscience launch clinical trial to test at-home headset for depression

Pharma Times

MAY 18, 2022

Device delivers currents to the brain to restore activity usually lowered in depression patients

ACMT Toxicology Visual Pearl: Needle to Necrosis

ALiEM - Pharm Pearls

NOVEMBER 29, 2023

When combined with illicit opioids such as heroin and fentanyl, xylazine may increase the risk of fatal overdose given the augmented sedation and respiratory depression effects [2]. Treatment consists of supportive care, ranging from IV fluids to mechanical ventilation in patients with severe respiratory depression [10]. N Engl J Med.

Hospitals

Efficacy of novel drug proven in MDD study

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.

FDA approves first-in-class antidepressant

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.

Novel pill could aid postpartum depression symptoms

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

Spalding Clinical and FDA research dangers of drug-opioid combinations

Outsourcing Pharma

JANUARY 30, 2023

The clinical trial was set up to investigate whether combining opioids with common psychotropic drugs would increase risk of respiratory depression.

Clinical Overview: Auvelity (Dextromethorphan and Bupropion) for Major Depressive Disorder

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.

SP-624 by Sirtsei Pharmaceuticals for Major Depressive Disorder: Likelihood of Approval

Pharmaceutical Technology

JANUARY 4, 2024

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

Zuranolone shows promise as episodic treatment for depression

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.

Labelling

Psilocybin improves depression symptoms, study shows

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.

Navigating the Psychedelic Renaissance: Emerging Mental Health Therapies and the Pharmacist’s Role

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.

FDA Breakthrough Therapy Designation Granted to Novel Psychedelic Molecule CYB003 for Major Depressive Disorder

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.

Large network of clinics offering ketamine for depression shuts down

Sleep Or Depression? Trazodone’s Dose Dependent Clinical Response

Trending Sources

STAT+: Intra-Cellular reports positive results in depression study aimed at expanding use of antipsychotic medicine

Opinion: What antidepressants are saying 30 years after the publication of ‘Listening to Prozac’

Opinion: As a rule, rape exceptions for abortion don’t work

STAT+: Relmada antidepressant drug fails first of several late-stage clinical trials

STAT+: FDA approves Sage Therapeutics’ rapid-acting medication for postpartum depression but not major depression

Mind-altering ketamine becomes latest pain treatment, despite little research or regulation

They’re immigrants, farmworkers, and new moms. And they’re facing postpartum depression at higher rates

STAT+: Flow Neuroscience shows promising results in trial of brain-stimulation headset for depression

STAT+: FDA’s Woodcock, other experts highlight persistent issues plaguing pharma, biotech in the wake of Covid-19

STAT+: With new study data, Intra-Cellular could expand use of approved mood-disorder treatment

Telehealth startups prescribing ketamine at home are stirring concern

STAT+: Pharmalittle: FDA OKs Sage drug for postpartum depression; major U.S. health systems to offer Alzheimer’s drug

STAT+: Pharmalittle: We’re reading about Lilly’s Zepbound for sleep apnea, the FDA budget, and more

Why depression after traumatic brain injury is distinct — and less likely to respond to standard treatment

STAT+: Sage hopes for a blockbuster in fast-acting antidepressant now before FDA

STAT+: Ketamine clinics’ bust serves as warning of business challenge facing psychedelic therapy

STAT+: Big Health acquires Limbix, maker of mental health app for depression in adolescents

‘I’m terrified’: Patients scramble for treatment after 13 ketamine clinics shut down

STAT+: Male birth control gets another shot with small new trial of non-hormonal pill

When young people survive cancer, their mental-health struggles are often just beginning

Cybin bags breakthrough tag for psychedelic depression drug

Exercise ‘may be better than drugs for depression’

High ADHD comorbidity rates offer opportunity for pipeline products to capture market: GlobalData

As psychedelics near approval, there’s no consensus on how they work

Depression now one of the top five most studied disease areas in clinical development, finds Phesi

STAT+: Pharmalittle: We’re reading about a failed schizophrenia drug trial, a Pfizer cancer drug, and more

Call for volunteers to test ground-breaking psychedelic treatments for mental health conditions

STAT+: J&J wins a partial appeal against the U.K.’s cost-effectiveness watchdog over ‘unfair’ review

STAT+: Telehealth companies that prescribed controlled substances during the pandemic brace for business to change

First oral medicine for postpartum depression approved

Curebase and Flow Neuroscience launch clinical trial to test at-home headset for depression

ACMT Toxicology Visual Pearl: Needle to Necrosis

Efficacy of novel drug proven in MDD study

FDA approves first-in-class antidepressant

Novel pill could aid postpartum depression symptoms

Spalding Clinical and FDA research dangers of drug-opioid combinations

Clinical Overview: Auvelity (Dextromethorphan and Bupropion) for Major Depressive Disorder

SP-624 by Sirtsei Pharmaceuticals for Major Depressive Disorder: Likelihood of Approval

Zuranolone shows promise as episodic treatment for depression

Psilocybin improves depression symptoms, study shows

Navigating the Psychedelic Renaissance: Emerging Mental Health Therapies and the Pharmacist’s Role

FDA Breakthrough Therapy Designation Granted to Novel Psychedelic Molecule CYB003 for Major Depressive Disorder

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