Dopamine antagonists

Newron Announces Results of Explanatory Studies With Evenamide in Healthy Volunteers and Patients With Schizophrenia

Retrieved on: 
Thursday, April 1, 2021
Research, Mental health, FDA, Clinical trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Branches of biology, Psychiatry, Medicine, Cardiac electrophysiology, Psychopathology, Dopamine antagonists, Antipsychotic, Atypical antipsychotics, QT interval, Schizophrenia, Electrocardiography, Psychosis, evenamide, Newron Pharmaceuticals

These results strongly suggest that evenamide does not increase a patients risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.

Key Points: 
  • These results strongly suggest that evenamide does not increase a patients risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.
  • No patient on evenamide discontinued from the study due to adverse events, and there were no significant adverse events relating to evenamide.
  • There were no differences in laboratory, ECG or vital signs abnormalities between evenamide and placebo-treated patients.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

DGAP-News: Newron announces results of explanatory studies with evenamide in healthy volunteers and patients with schizophrenia

Retrieved on: 
Thursday, April 1, 2021
Psychiatry, Receptor antagonists, Branches of biology, Psychopathology, Dopamine antagonists, Schizophrenia, Atypical antipsychotics, Chloroarenes, Antipsychotic, Psychosis, QT interval, Management of schizophrenia, evenamide, Newron Pharmaceuticals

These results strongly suggest that evenamide does not increase a patient's risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.

Key Points: 
  • These results strongly suggest that evenamide does not increase a patient's risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.
  • No patient on evenamide discontinued from the study due to adverse events, and there were no significant adverse events relating to evenamide.
  • Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Dr. Reddy's Laboratories announces the launch of Fluphenazine Hydrochloride Tablets, USP in the U.S. Market

Retrieved on: 
Thursday, February 18, 2021
Biotechnology, FDA, Pharmaceutical, Health, Dopamine antagonists, Psychiatry, Branches of biology, Clinical medicine, Antiemetics, Typical antipsychotics, Antipsychotic, Cognitive disorders, Psychiatric diagnosis, Atypical antipsychotic, Psychosis, Dementia

Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Key Points: 
  • Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.
  • Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
  • Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.
  • Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

Ben-Gurion University Researchers Develop Novel Method for Personalizing Dose of Schizophrenia Drug Clozapine

Retrieved on: 
Tuesday, February 16, 2021
Drugs, Receptor antagonists, Psychiatry, Dopamine antagonists, Psychopathology, Atypical antipsychotics, Mood stabilizers, Piperazines, Clozapine, Schizophrenia, Antipsychotic, Psychosis

Clozapine is considered the most effective antipsychotic medication for schizophrenia and the only antipsychotic currently approved for treatment-resistant schizophrenia but is also associated with harsh side effect.

Key Points: 
  • Clozapine is considered the most effective antipsychotic medication for schizophrenia and the only antipsychotic currently approved for treatment-resistant schizophrenia but is also associated with harsh side effect.
  • As a result, clozapine is still one of the most underutilized evidence-based treatments in the field of mental health.
  • Importantly, the technology underlying this novel clozapine sensor can be used as a platform for the detection of additional substances.
  • Electrochemistry Communications 120 (2020) 106850; https://doi.org/10.1016/j.elecom.2020.106850
    BGN Technologiesis the technology transfer companyof Ben-Gurion University, the third largest university in Israel.

Newron Completes Enrollment of Explanatory Safety and Efficacy Study With Evenamide in Schizophrenia Patients

Retrieved on: 
Thursday, January 21, 2021
Research, FDA, Clinical trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Psychiatry, Receptor antagonists, Drugs, Dopamine antagonists, Psychopathology, Atypical antipsychotics, Mood stabilizers, Antipsychotic, Psychosis, Clozapine, Schizophrenia, Typical antipsychotic, evenamide, Newron Pharmaceuticals

Enrollment to the study has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the United States and India.

Key Points: 
  • Enrollment to the study has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the United States and India.
  • The proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine.
  • Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

DGAP-News: Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients

Retrieved on: 
Thursday, January 21, 2021
Psychiatry, Receptor antagonists, Drugs, Dopamine antagonists, Psychopathology, Atypical antipsychotics, Mood stabilizers, Antipsychotic, Psychosis, Clozapine, Schizophrenia, Typical antipsychotic, evenamide, Newron Pharmaceuticals

Enrollment to the study has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the United States and India.

Key Points: 
  • Enrollment to the study has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the United States and India.
  • The proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine.
  • Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review

Retrieved on: 
Tuesday, November 17, 2020
Drugs, Receptor antagonists, Serotonin antagonists, Opioid antagonists, Atypical antipsychotics, Dopamine antagonists, Muscarinic antagonists, Combination drugs, Olanzapine/samidorphan, Samidorphan, Alkermes, ALKS

Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved.

Key Points: 
  • Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved.
  • FDA confirmed receipt of the requested records provided by Alkermes on Sept. 11, 2020 and, since that date, no report or feedback from this records review was provided to Alkermes until receipt of the CRL.
  • The NDA submission for ALKS 3831 was based on data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone, and pharmacokinetic bridging data comparing ALKS 3831 and ZYPREXA.
  • Throughout the clinical development program, ALKS 3831 demonstrated a consistent antipsychotic efficacy, safety, and tolerability profile in patients with schizophrenia.

Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review

Retrieved on: 
Tuesday, November 17, 2020
Drugs, Receptor antagonists, Serotonin antagonists, Opioid antagonists, Atypical antipsychotics, Dopamine antagonists, Muscarinic antagonists, Combination drugs, Olanzapine/samidorphan, Samidorphan, Alkermes, ALKS

Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved.

Key Points: 
  • Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved.
  • FDA confirmed receipt of the requested records provided by Alkermes on Sept. 11, 2020 and, since that date, no report or feedback from this records review was provided to Alkermes until receipt of the CRL.
  • The NDA submission for ALKS 3831 was based on data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone, and pharmacokinetic bridging data comparing ALKS 3831 and ZYPREXA.
  • Throughout the clinical development program, ALKS 3831 demonstrated a consistent antipsychotic efficacy, safety, and tolerability profile in patients with schizophrenia.

FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder

Retrieved on: 
Friday, October 9, 2020
Receptor antagonists, Drugs, Serotonin antagonists, Atypical antipsychotics, Opioid antagonists, Dopamine antagonists, Muscarinic antagonists, RTT, Olanzapine/samidorphan, Samidorphan, Antipsychotic, Olanzapine

The committees met to discuss ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

Key Points: 
  • The committees met to discuss ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.
  • "Thefavorableoutcome of today's joint advisory committee meeting represents an important milestone for the patients, clinicians and families who may benefit from new medicines for the treatment of schizophrenia and bipolar I disorder.
  • "The ALKS 3831 development program is part of our ongoing commitment to develop new therapeutic options for adults living with serious mental illness.
  • ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder

Retrieved on: 
Friday, October 9, 2020
Receptor antagonists, Drugs, Serotonin antagonists, Atypical antipsychotics, Opioid antagonists, Dopamine antagonists, Muscarinic antagonists, RTT, Olanzapine/samidorphan, Samidorphan, Antipsychotic, Olanzapine

The committees met to discuss ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

Key Points: 
  • The committees met to discuss ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.
  • "Thefavorableoutcome of today's joint advisory committee meeting represents an important milestone for the patients, clinicians and families who may benefit from new medicines for the treatment of schizophrenia and bipolar I disorder.
  • "The ALKS 3831 development program is part of our ongoing commitment to develop new therapeutic options for adults living with serious mental illness.
  • ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.