Psychiatry/Psychology | Phase II Developments | UNITED STATES

Relmada Therapeutics

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Relmada Therapeutics Announces Notice of Allowance for Patent in Canada Covering REL-1017 for Treatment of Psychiatric Symptoms

Lead Product(s): Dextromethadone

Therapeutic Area: Psychiatry/Psychology Product Name: REL-1017

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 23, 2020

Details:

The patent that will issue from this allowed application provides broad coverage in Canada for REL-1017 (d-methadone, dextromethadone,) for the treatment of symptoms associated with a wide range of psychological and psychiatric disorders.

American BriVision

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American BriVision Announces Completed Patient Enrollment in Clinical Trial at UCSF for Treatment of Adult ADHD

Lead Product(s): PDC-1421

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 2020

Details:

Patient enrollment has been completed for a Phase II Part I clinical trial at the University of California. Primary objective of clinical trial is to determine the effective dosage of ABV-1505 in treatment of adult attention-deficit hyperactivity disorder (ADHD).

Relmada Therapeutics

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Relmada Therapeutics Announces Outcome of End-of-Phase 2 Meeting with FDA for REL-1017

Lead Product(s): Dextromethadone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2020

Details:

Relmada Therapeutics completed its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on its development program of REL-1017 (dextromethadone) for the adjunctive treatment of major depressive disorder (MDD) patients.

Acadia Pharmaceuticals

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ACADIA Pharmaceuticals to Present Pimavanserin Clinical Data at the 2020 ASCP Virtual Annual Meeting

Lead Product(s): Pimavanserin

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 21, 2020

Details:

Multiple scientific presentations and abstracts evaluating pimavanserin in clinical studies for the treatment of various central nervous system (CNS) disorders will be highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting.

VistaGen Therapeutics

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VistaGen Submits PH94B Phase 2A Study Protocol for Treatment of Adjustment Disorder with Anxiety Related to the COVID-19 Pandemic

Lead Product(s): PH94B

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2020

Details:

The proposed Phase 2A study of PH94B will an open-label basis and involve approximately 30 patients suffering from adjustment disorder with anxiety from stressors related to the pandemic.

Achieve Life Sciences

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Achieve Reports Provides Update on Cytisinicline Development Program

Lead Product(s): Cytisinicline

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 14, 2020

Details:

Company submitted required non-clinical supportive data for longer cytisinicline treatment to the U.S. Food & Drug Administration (FDA) in preparation for Phase 3 cytisinicline ORCA-2 trial initiation.

Sound Pharmaceuticals

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University of Oxford and Sound Pharmaceuticals Complete Phase 2 Bipolar Disorder Study with SPI-1005

Lead Product(s): Ebselen

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2020

Details:

The study shows important preliminary evidence of therapeutic activity for SPI-1005 in bipolar disorder. SPI-1005 treated patients had a 11.8-point reduction in Young Mania Rating Scale scores.

American BriVision

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American BriVision Conducts Site Monitoring Visit for Phase II Part I Clinical Trial for ABV-1505

Lead Product(s): PDC-1421

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 06, 2020

Details:

PDC-1421, the active ingredient of ABV-1505, is being expanded into Adult ADHD trials following encouraging Phase II trial results in major depressive disorder (MDD).

American BriVision

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American BriVision First Patient Enrolled for Phase II Part I Clinical Trial for ABV-1505

Lead Product(s): PDC-1421

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 04, 2020

Details:

First of six patients has been enrolled for Phase II Part I trial of ABV-1505 at the University of California, San Francisco (UCSF) Medical Center.

VistaGen Therapeutics

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VistaGen Announces Positive Results of Newly Published Exploratory Phase 2a Study of PH10

Lead Product(s): PH10

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 20, 2020

Details:

PH10, demonstrated significant rapid-onset antidepressive benefit versus placebo, without psychological side effects or safety concerns often associated with Ketamine-based Therapy.

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Relmada Therapeutics

Relmada Therapeutics Announces Notice of Allowance for Patent in Canada Covering REL-1017 for Treatment of Psychiatric Symptoms

American BriVision

American BriVision Announces Completed Patient Enrollment in Clinical Trial at UCSF for Treatment of Adult ADHD

Relmada Therapeutics

Relmada Therapeutics Announces Outcome of End-of-Phase 2 Meeting with FDA for REL-1017

Acadia Pharmaceuticals

ACADIA Pharmaceuticals to Present Pimavanserin Clinical Data at the 2020 ASCP Virtual Annual Meeting

VistaGen Therapeutics

VistaGen Submits PH94B Phase 2A Study Protocol for Treatment of Adjustment Disorder with Anxiety Related to the COVID-19 Pandemic

Achieve Life Sciences

Achieve Reports Provides Update on Cytisinicline Development Program

Sound Pharmaceuticals

University of Oxford and Sound Pharmaceuticals Complete Phase 2 Bipolar Disorder Study with SPI-1005

American BriVision

American BriVision Conducts Site Monitoring Visit for Phase II Part I Clinical Trial for ABV-1505

American BriVision

American BriVision First Patient Enrolled for Phase II Part I Clinical Trial for ABV-1505

VistaGen Therapeutics

VistaGen Announces Positive Results of Newly Published Exploratory Phase 2a Study of PH10