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FDA Updates

Latest News

Increase in Suicidality Associated With FDA Black Box Warning Implementation
News
Increase in Suicidality Associated With FDA Black Box Warning Implementation
10/11/2024
Black box warnings on antidepressants from the FDA warning of increased risk of suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, according to a systematic...
Black box warnings on antidepressants from the FDA warning of increased risk of suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, according to a systematic...
Black box warnings on...
10/11/2024
Psych Congress Network
FDA approval featuring craig chepke
News
FDA Approves First Schizophrenia Treatment in Over 3 Decades
09/27/2024
The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
The US Food and Drug...
09/27/2024
Psych Congress Network
fda building sign
News
FDA Rejection of MDMA-Assisted Therapy for PTSD Divides Psychedelic Stakeholders
08/16/2024
The US Food and Drug Administration (FDA) last week rejected the new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD) in conjunction with...
The US Food and Drug Administration (FDA) last week rejected the new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD) in conjunction with...
The US Food and Drug...
08/16/2024
Psych Congress Network
FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
News
FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
07/24/2024
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug...
07/24/2024
Psych Congress Network
FDA building sign
News
FDA Declines to Approve OX124 Nasal Spray for Opioid Overdose Treatment
07/23/2024
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug...
07/23/2024
Psych Congress Network
lab work
News
Dosing Starts in Pharmacokinetics Study of AD04 for Alcohol Use Disorder
07/08/2024
A pharmacokinetics study of AD04, a potential treatment for AUD, is designed to meet an FDA requirement for an upcoming phase 3 trial and is expected to last 6 months.
A pharmacokinetics study of AD04, a potential treatment for AUD, is designed to meet an FDA requirement for an upcoming phase 3 trial and is expected to last 6 months.
A pharmacokinetics study of...
07/08/2024
Psych Congress Network
Video Game Treatment for Adults With ADHD Cleared by FDA
News
Video Game Treatment for Adults With ADHD Cleared by FDA
07/02/2024
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
AKL-T01 is indicated for adults...
07/02/2024
Psych Congress Network
FDA Approves First Liquid, Non-Stimulant for Pediatric ADHD
News
FDA Approves First Liquid, Non-Stimulant for Pediatric ADHD
06/11/2024
The FDA approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of ADHD in patients 6 years and older.
The FDA approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of ADHD in patients 6 years and older.
The FDA approved Tris Pharma,...
06/11/2024
Psych Congress Network
FDA
News
FDA Advisory Committee Rejects First MDMA Treatment for PTSD
06/06/2024
FDA committee rejected an MDMA-based therapy for adult PTSD treatment due to concerns about its effectiveness and the reliability of the data, despite positive study results.
FDA committee rejected an MDMA-based therapy for adult PTSD treatment due to concerns about its effectiveness and the reliability of the data, despite positive study results.
FDA committee rejected an...
06/06/2024
Psych Congress Network
: FDA Approves Oral Valbenazine Granule Formulation, an Alternative Administration Option for Adults With TD
News
FDA Approves Oral Valbenazine Granule Formulation, an Alternative Administration Option for Adults With TD
05/15/2024
At the end of April, Neurocrine Biosciences, Inc. announced the approval of INGREZZA® SPRINKLE (valbenazine) capsules by the FDA. This approval provides an alternative option for patients with dysphagia or who have difficulty swallowing. 
At the end of April, Neurocrine Biosciences, Inc. announced the approval of INGREZZA® SPRINKLE (valbenazine) capsules by the FDA. This approval provides an alternative option for patients with dysphagia or who have difficulty swallowing. 
At the end of April, Neurocrine...
05/15/2024
Psych Congress Network
Adults Who Smoke Have More Chronic Pain, Use More Opioids
News
Adults Who Smoke Have More Chronic Pain, Use More Opioids
11/07/2024
Rates of chronic pain, prescription opioid use, and severe work limitations rise with the number of cigarettes smoked daily, according to study results published in the American Journal of Preventive Medicine.
Rates of chronic pain, prescription opioid use, and severe work limitations rise with the number of cigarettes smoked daily, according to study results published in the American Journal of Preventive Medicine.
Rates of chronic pain,...
11/07/2024
Psych Congress Network
Patient survey
News
Patient Survey Identifies Barriers to TD Treatment
11/06/2024
Key barriers to tardive dyskinesia (TD) diagnosis include a lack of communication with the health care professional, lack of a physical exam, and low educational and socioeconomic status, according to a survey of adults with TD symptoms.
Key barriers to tardive dyskinesia (TD) diagnosis include a lack of communication with the health care professional, lack of a physical exam, and low educational and socioeconomic status, according to a survey of adults with TD symptoms.
Key barriers to tardive...
11/06/2024
Psych Congress Network
Semaglutide May Lower Risk of Alzheimer Disease in Patients With Type 2 Diabetes
News
Semaglutide May Lower Risk of Alzheimer Disease in Patients With Type 2 Diabetes
11/05/2024
Patients with type 2 diabetes and obesity prescribed semaglutide had a 40% to 70% lower risk of a first-time Alzheimer disease (AD) diagnosis compared with patients taking other antidiabetic medications, according to a study published in...
Patients with type 2 diabetes and obesity prescribed semaglutide had a 40% to 70% lower risk of a first-time Alzheimer disease (AD) diagnosis compared with patients taking other antidiabetic medications, according to a study published in...
Patients with type 2 diabetes...
11/05/2024
Psych Congress Network
depression stock photo
News
Add-on Lumateperone Eases MDD in Patients With Inadequate Antidepressant Response
11/04/2024
Adjunctive treatment with the atypical antipsychotic lumateperone improved depressive symptoms and severity more than adjunctive placebo in patients with MDD with inadequate response to previous antidepressant therapy, according to a poster...
Adjunctive treatment with the atypical antipsychotic lumateperone improved depressive symptoms and severity more than adjunctive placebo in patients with MDD with inadequate response to previous antidepressant therapy, according to a poster...
Adjunctive treatment with the...
11/04/2024
Psych Congress Network
Conference presenter
News
Olanzapine/Samidorphan Demonstrates Favorable Safety Profile in 4-Year Open-Label Study
11/01/2024
Combination olanzapine/samidorphan (OLZ/SAM) maintained consistent symptom control in patients with schizophrenia or bipolar I disorder and demonstrated a favorable long-term safety profile over 4 years consistent with previous studies.
Combination olanzapine/samidorphan (OLZ/SAM) maintained consistent symptom control in patients with schizophrenia or bipolar I disorder and demonstrated a favorable long-term safety profile over 4 years consistent with previous studies.
Combination...
11/01/2024
Psych Congress Network
A person steps onto a scale
News
Neuropsychiatric Side Effects Reported With CB1 Weight-Loss Drug
10/16/2024
Monlunabant was associated with statistically significant weight loss, but the drug was also linked with mild to moderate neuropsychiatric side effects.
Monlunabant was associated with statistically significant weight loss, but the drug was also linked with mild to moderate neuropsychiatric side effects.
Monlunabant was associated with...
10/16/2024
Psych Congress Network
Increase in Suicidality Associated With FDA Black Box Warning Implementation
News
Increase in Suicidality Associated With FDA Black Box Warning Implementation
10/11/2024
Black box warnings on antidepressants from the FDA warning of increased risk of suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, according to a systematic...
Black box warnings on antidepressants from the FDA warning of increased risk of suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, according to a systematic...
Black box warnings on...
10/11/2024
Psych Congress Network
An orange prescription container with generic pills spilling out in front of it
News
Masked Taper Plus CBT for Insomnia Effective in Benzodiazepine Discontinuation
10/10/2024
A masked drug taper combined with cognitive behavioral therapy for insomnia (CBTI) were associated with improved benzodiazepine receptor agonist discontinuation in patients receiving treatment for insomnia
A masked drug taper combined with cognitive behavioral therapy for insomnia (CBTI) were associated with improved benzodiazepine receptor agonist discontinuation in patients receiving treatment for insomnia
A masked drug taper combined...
10/10/2024
Psych Congress Network
Bright Light Therapy Effective for Depressive Disorders, May Improve Treatment Response Time
News
Bright Light Therapy Effective for Depressive Disorders, May Improve Treatment Response Time
10/09/2024
Bright light therapy (BLT) may be an effective adjunctive treatment for non-seasonal depressive disorders and improve response time for the initial treatment, according to results from a recent systematic review and meta-analysis published in...
Bright light therapy (BLT) may be an effective adjunctive treatment for non-seasonal depressive disorders and improve response time for the initial treatment, according to results from a recent systematic review and meta-analysis published in...
Bright light therapy (BLT) may...
10/09/2024
Psych Congress Network
Psilocybin
News
Psilocybin May Improve Outcomes More Than Traditional MDD Treatments
10/08/2024
While intensive treatments with psilocybin and the serotonin reuptake inhibitor (SSRI) escitalopram were associated with long-term improvements in major depressive disorder (MDD) symptom severity, recent phase 2 double-blind, randomized,...
While intensive treatments with psilocybin and the serotonin reuptake inhibitor (SSRI) escitalopram were associated with long-term improvements in major depressive disorder (MDD) symptom severity, recent phase 2 double-blind, randomized,...
While intensive treatments with...
10/08/2024
Psych Congress Network

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Exclusives

andrew penn
Videos
Decoding the FDA Committee's Decision to Reject MDMA-Assisted Therapy: Part 2
07/01/2024
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP,...
07/01/2024
Psych Congress Network
andrew penn
Videos
Decoding the FDA Committee's Decision to Reject MDMA-Assisted Therapy With Andrew Penn, MS, PMHNP
06/21/2024
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP,...
06/21/2024
Psych Congress Network
Jonathan Meyer, MD
Videos
Unpacking Negative Symptoms, Medication Adverse Effects, and Emerging Schizophrenia Treatments
11/11/2024
Jonathan Meyer, MD, offers his clinical insights on schizophrenia management.
Jonathan Meyer, MD, offers his clinical insights on schizophrenia management.
Jonathan Meyer, MD, offers his...
11/11/2024
Psych Congress Network
Thomas L. Schwartz, MD
Q&As
How Psychiatrists Can Address Sleep-Wake Disorders Effectively
11/09/2024
Thomas L. Schwartz, MD, shares exclusive insights from his session on sleep-wake issues presented at the 2024 NEI Fall Congress.
Thomas L. Schwartz, MD, shares exclusive insights from his session on sleep-wake issues presented at the 2024 NEI Fall Congress.
Thomas L. Schwartz, MD, shares...
11/09/2024
Psychiatry & Behavioral Health
Desiree Matthews
Schizophrenia Conference Insights
New Class of Medication Offers Innovative Treatment for Schizophrenia Symptoms
11/07/2024
Watch these exclusive insights with Desiree Matthews, PMHNP-BC, to learn how this novel treatment could reshape the landscape of care for adults living with schizophrenia.
Watch these exclusive insights with Desiree Matthews, PMHNP-BC, to learn how this novel treatment could reshape the landscape of care for adults living with schizophrenia.
Watch these exclusive insights...
11/07/2024
Psych Congress Network
Marc Agronin
Videos
Implementing Alzheimer Disease Prevention Practices
11/02/2024
Dr Marc Agronin discusses some easy prevention strategies for Alzheimer disease following his Psych Congress 2024 session "A New Era for Alzheimer’s Disease: Prevention, Early Diagnosis, Effective Intervention."
Dr Marc Agronin discusses some easy prevention strategies for Alzheimer disease following his Psych Congress 2024 session "A New Era for Alzheimer’s Disease: Prevention, Early Diagnosis, Effective Intervention."
Dr Marc Agronin discusses some...
11/02/2024
Psych Congress Network
Michelle Martel, PhD
Q&As
When It Comes to ADHD in Women, There's Still So Much to Learn
10/31/2024
Michelle Martel, PhD, shares insights from her session on ADHD in women presented at the 2024 Psych Congress.
Michelle Martel, PhD, shares insights from her session on ADHD in women presented at the 2024 Psych Congress.
Michelle Martel, PhD, shares...
10/31/2024
Psych Congress Network
Andrew Penn
Q&As
Psychedelics: New Research, Regulations, and Horizons
10/30/2024
"Psychedelic therapies must continue to be researched so that perhaps, someday with their help, we will be able to help our patients live their best lives," Andrew Penn, PMHNP-BC.
"Psychedelic therapies must continue to be researched so that perhaps, someday with their help, we will be able to help our patients live their best lives," Andrew Penn, PMHNP-BC.
"Psychedelic therapies must...
10/30/2024
Psych Congress Network
Jo Hughes
Q&As
Unpacking the Pressing Challenges of Polypharmacy in Psychiatry
10/30/2024
Jo Hughes, DMSc, PA-C, CAQ-PSY, discusses the complexities of polypharmacy in psychiatry and the balance between medication management and patient safety.
Jo Hughes, DMSc, PA-C, CAQ-PSY, discusses the complexities of polypharmacy in psychiatry and the balance between medication management and patient safety.
Jo Hughes, DMSc, PA-C, CAQ-PSY,...
10/30/2024
Psych Congress Network
Beau Kilmer, PhD
Q&As
Psychedelic Policy and Market Considerations
10/28/2024
Dr Kilmer discusses the psychedelic market in the United States, policy on both state and local levels, and the role of the federal government in regulation.
Dr Kilmer discusses the psychedelic market in the United States, policy on both state and local levels, and the role of the federal government in regulation.
Dr Kilmer discusses the...
10/28/2024
Psych Congress Network
Christoph Correll, MD.
Videos
Strategies to Manage Adverse Effects From Schizophrenia Treatment
10/28/2024
Christoph Correll, MD, offers clinical guidance for managing adverse affects from schizophrenia treatment, including weight gain and movement disorder
Christoph Correll, MD, offers clinical guidance for managing adverse affects from schizophrenia treatment, including weight gain and movement disorder
Christoph Correll, MD, offers...
10/28/2024
Psych Congress Network
Christoph Correll, MD
Videos
Beyond D2 Receptor Manipulation: Novel Agents for Schizophrenia Treatment
10/16/2024
Christoph Correll, MD, provides a thorough pharmacological overview of the traditional and novel treatments available for schizophrenia.
Christoph Correll, MD, provides a thorough pharmacological overview of the traditional and novel treatments available for schizophrenia.
Christoph Correll, MD, provides...
10/16/2024
Psych Congress Network

Refresher Quizzes

FDA
Quiz
What were the FDA's preliminary findings after investigating GLP-1 RAs?
04/25/2024
Do you remember this FDA update?
Do you remember this FDA update?
Do you remember this FDA update?
04/25/2024
Psych Congress Network
Pop quiz written on a blackboard with white chalk
Expert Insights Quiz
LAIs and Telehealth Psychiatric Care
10/24/2024
Test your knowledge with this quick quiz!
Test your knowledge with this quick quiz!
Test your knowledge with this...
10/24/2024
Psych Congress Network
Four people ponder with question marks over their heads
Quiz
Adult ADHD Diagnosis Rates
10/23/2024
Take the quiz to test your knowledge!
Take the quiz to test your knowledge!
Take the quiz to test your...
10/23/2024
Psych Congress Network
Jonathan Meyer
Quiz
How do muscarinic acetylcholine receptor activators differ from traditional antipsychotic treatments?
10/23/2024
How do muscarinic acetylcholine receptor activators differ from traditional antipsychotic treatments? Take the quiz to find out!
How do muscarinic acetylcholine receptor activators differ from traditional antipsychotic treatments? Take the quiz to find out!
How do muscarinic acetylcholine...
10/23/2024
Psych Congress NP Institute
pop quiz
Quiz
Esketamine Dosing Schedule for Treatment-Resistant Depression
10/01/2024
During the induction and maintenance phases of esketamine treatment, how frequently should the medication be administered to treat TRD? Take the quiz to test your psychopharmacology knowledge.
During the induction and maintenance phases of esketamine treatment, how frequently should the medication be administered to treat TRD? Take the quiz to test your psychopharmacology knowledge.
During the induction and...
10/01/2024
Psych Congress Network
Pop quiz written on a blackboard with white chalk
Quiz
Telehealth Versus In-Person Psychiatric Care
09/19/2024
Do you know what the data from randomized control trials say?
Do you know what the data from randomized control trials say?
Do you know what the data from...
09/19/2024
Psych Congress Network
How many ADHD prescriptions are affected by the med shortage?
Quiz
How many ADHD prescriptions are affected by the med shortage?
09/17/2024
Take a quick poll on your recent prescribing practices!
Take a quick poll on your recent prescribing practices!
Take a quick poll on your recent...
09/17/2024
Psych Congress Network
Symptom Reduction in Bipolar Disorder Treatment
Expert Insights Quiz
Symptom Reduction in Bipolar Disorder Treatment
09/13/2024
Test your knowledge
Test your knowledge
Test your knowledge
09/13/2024
Psych Congress Network
Pop quiz written on a blackboard with white chalk
Quiz
CDC/AAP Treatment Guidelines for Pediatric ADHD
09/11/2024
Test your knowledge with this quick quiz!
Test your knowledge with this quick quiz!
Test your knowledge with this...
09/11/2024
Psych Congress Network
A person completes a puzzle of a profile of a head, with a piece missing from where the brain is located.
Quiz
Considerations When Prescribing Deutetrabenazine for Tardive Dyskinesia
09/10/2024
Put your clinical knowledge to the test with this quiz!
Put your clinical knowledge to the test with this quiz!
Put your clinical knowledge to...
09/10/2024
Psych Congress Network
A person completes a puzzle of a profile of a head, with a piece missing from where the brain is located.
Quiz
Considerations When Prescribing Deutetrabenazine for Tardive Dyskinesia
09/10/2024
Put your clinical knowledge to the test with this quiz!
Put your clinical knowledge to the test with this quiz!
Put your clinical knowledge to...
09/10/2024
Psych Congress Network

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NEW FROM THE NP INSTITUTE ONLINE LEARNING HUB

andrew and julie
Rapid Refresh
Navigating Bipolar Disorder Treatment: Exploring the Role of Second-Generation Antipsychotics
04/11/2024

Featuring Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN

Featuring Andrew Penn, MS, PMHNP, and...
Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN, explore the nuanced role of second-generation antipsychotics in bipolar disorder treatment. They discuss the complexities of managing mania and depression phases and...
Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN, explore the nuanced role of second-generation antipsychotics in bipolar disorder treatment. They discuss the complexities of managing mania and depression phases and...
Andrew Penn, MS, PMHNP, and...
04/11/2024
Psych Congress NP Institute
Amber Hoberg
Rapid Refresh
Long-Acting Injectables for Adolescents With Schizophrenia and Schizoaffective Disorder
04/10/2024
Amber Hoberg, PMHNP-BC, navigates the complexities of adolescent psychosis treatment, exploring the potential benefits and considerations of LAIs for schizophrenia and schizoaffective disorder, while emphasizing evidence-based practice for...
Amber Hoberg, PMHNP-BC, navigates the complexities of adolescent psychosis treatment, exploring the potential benefits and considerations of LAIs for schizophrenia and schizoaffective disorder, while emphasizing evidence-based practice for...
Amber Hoberg, PMHNP-BC,...
04/10/2024
Psych Congress NP Institute
Hoberg and Matthews
Clinical Pearls
Tolerability Testing in Long-Acting Injectable Prescriptions
04/03/2024
Do clinicians need to test for tolerability before prescribing a long-acting injectable (LAI)? Desiree Matthews, PMHNP-BC, and Amber Hoberg, MSN, APRN, PMHNP-BC, offer their clinical insight.
Do clinicians need to test for tolerability before prescribing a long-acting injectable (LAI)? Desiree Matthews, PMHNP-BC, and Amber Hoberg, MSN, APRN, PMHNP-BC, offer their clinical insight.
Do clinicians need to test for...
04/03/2024
Psych Congress NP Institute

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