Psychiatry/Psychology | Phase III Developments | UNITED STATES

Adial Pharmaceuticals

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Adial Pharmaceuticals Announces Approval to Commence Landmark ONWARD(TM) Pivotal Phase 3 Trial in Poland

Lead Product(s): Ondansetron

Therapeutic Area: Psychiatry/Psychology Product Name: Zofran

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

Adial has received approvals to commence its landmark ONWARD™ pivotal Phase 3 clinical trial in Poland to investigate AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons genotypes related to the serotonin transporter and receptor genes.

Minerva Neurosciences

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Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia

Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 29, 2020

Details:

The 64 mg and 32 mg doses were not statistically significantly different from placebo at Week 12 on the primary endpoint, the PANSS Marder Negative Symptoms Factor Score, or the key secondary endpoint, the Personal and Social Performance Scale Total Score.

Minerva Neurosciences

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Minerva Neurosciences’ Roluperidone Fails In Phase III Study

Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 29, 2020

Details:

The 64 mg and 32 mg doses were not statistically significantly different from placebo at Week 12 on the primary endpoint, the PANSS Marder Negative Symptoms Factor Score, or the key secondary endpoint, the Personal and Social Performance Scale Total Score.

Acadia Pharmaceuticals

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ACADIA Pharmaceuticals to Combine CLARITY-2 and CLARITY-3 Phase 3 Studies Evaluating Pimavanserin for Major Depressive Disorder

Lead Product(s): Pimavanserin

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 26, 2020

Details:

CLARITY-2 and CLARITY-3 are both 6-week, parallel-designed, randomized, double-blind, placebo-controlled, multi-center studies designed to evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with MDD.

Adamis Pharmaceuticals

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Adamis Pharmaceuticals Resubmits ZIMHI New Drug Application to FDA

Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III 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 resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 Complete Response Letter.

BioXcel Therapeutics

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BioXcel Therapeutics Announces Completion of Patient Enrollment in Phase 3 SERENITY Trials with BXCL501

Lead Product(s): Dexmedetomidine

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III 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:

SERENITY I is evaluating patients with agitation associated with schizophrenia, with each of three arms receiving BXCL501 at 120 micrograms, 180 micrograms or placebo.

Sunovion Pharmaceuticals

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Sunovion Ditches Once-Rejected ADHD, Binge Eating Program

Lead Product(s): Dasotraline

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 13, 2020

Details:

Sunovion has withdrawn the New Drug Applications for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, for the treatment of moderate-to-severe binge eating disorder (BED) and attention deficit hyperactivity disorder (ADHD).

KemPharm

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KemPharm Eligible to Receive $5 Million Milestone Payment from Gurnet Point Capital After NDA Filing for Potential New ADHD Treatment

Lead Product(s): Serdexmethylphenidate

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Corium International, Inc.

Deal Size: $5.0 million Upfront Cash: Not Applicable

Deal Type: Collaboration May 04, 2020

Details:

KP415 is KemPharm’s product candidate for the treatment of attention deficit hyperactivity disorder (ADHD), which contains serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH).

Adamis Pharmaceuticals

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Adamis Pharmaceuticals Announces Publication Demonstrating PET Scan Results of Higher Dose Naloxone in Monkeys

Lead Product(s): Naloxone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2020

Details:

The study found that higher doses of naloxone resulted in an increased number of naloxone-bound brain receptors, thereby lowering the number of brain receptors bound with the opioid.

Sunovion Pharmaceuticals

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New England Journal of Medicine Publishes Pivotal Results Evaluating Sunovion’s SEP-363856 for the Treatment of Schizophrenia

Lead Product(s): SEP-363856

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 15, 2020

Details:

Significantly greater improvement in the Positive and Negative Symptom Scale was demonstrated in schizophrenia patients treated with SEP-363856, a TAAR1 agonist, compared to placebo.

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Adial Pharmaceuticals

Adial Pharmaceuticals Announces Approval to Commence Landmark ONWARD(TM) Pivotal Phase 3 Trial in Poland

Minerva Neurosciences

Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia

Minerva Neurosciences

Minerva Neurosciences’ Roluperidone Fails In Phase III Study

Acadia Pharmaceuticals

ACADIA Pharmaceuticals to Combine CLARITY-2 and CLARITY-3 Phase 3 Studies Evaluating Pimavanserin for Major Depressive Disorder

Adamis Pharmaceuticals

Adamis Pharmaceuticals Resubmits ZIMHI New Drug Application to FDA

BioXcel Therapeutics

BioXcel Therapeutics Announces Completion of Patient Enrollment in Phase 3 SERENITY Trials with BXCL501

Sunovion Pharmaceuticals

Sunovion Ditches Once-Rejected ADHD, Binge Eating Program

KemPharm

KemPharm Eligible to Receive $5 Million Milestone Payment from Gurnet Point Capital After NDA Filing for Potential New ADHD Treatment

Adamis Pharmaceuticals

Adamis Pharmaceuticals Announces Publication Demonstrating PET Scan Results of Higher Dose Naloxone in Monkeys

Sunovion Pharmaceuticals

New England Journal of Medicine Publishes Pivotal Results Evaluating Sunovion’s SEP-363856 for the Treatment of Schizophrenia