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Find Psychiatry/Psychology Drugs in Phase III Clinical Development in UNITED STATES

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            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.

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            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.

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            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.

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            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.

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            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.

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            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.

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            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).

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            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).

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            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.

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            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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