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

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            Lead Product(s): Arketamine

            Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 19, 2021

            Details:

            PCN-101 was safe and well-tolerated at all doses up to 150 mg, the highest dose tested. There were no serious adverse events reported. The pharmacokinetics of PCN-101 in plasma were approximately dose-proportional.

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            Lead Product(s): ELE-Psilo+

            Therapeutic Area: Psychiatry/Psychology Product Name: ELE-Psilo+

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Eleusis

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition December 14, 2020

            Details:

            ELE-Ket+ and ELE-Psilo+ are expected to enter Phase II clinical trials for the adjunctive treatment of major depressive disorder at the end of 2021. Under the terms of the agreement, Eleusis will acquire Kalypso and its intellectual property in an all-stock transaction.

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            Lead Product(s): Nalmefene

            Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: BARDA

            Deal Size: $8.1 million Upfront Cash: Undisclosed

            Deal Type: Funding December 14, 2020

            Details:

            An earlier award of $4.6 million from BARDA, combined with a $7.4 million grant Opiant received from the NIDA, also supports the clinical development and U.S. regulatory submission of OPNT003. The grant increases total potential value of the BARDA contract to $8.1 million.

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            Lead Product(s): D-Amphetamine Sulfate

            Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 09, 2020

            Details:

            Results demonstrated that ADAIR had slower absorption and lower early exposure, and was less desirable to recreational drug abusers on key measures of abuse liability compared to commercially available dextroamphetamine.

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            Lead Product(s): Nalmefene

            Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Opiant Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership October 29, 2020

            Details:

            Agreement combines Opiant’s opioid antagonist OPNT003 nasal nalmefene, with Aptar's FDA-approved Unit Dose System delivery device. OPNT003 is a nasal nalmefene for use in conjunction with Aptar’s Unit Dose System (UDS) for the treatment of opioid overdose.

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            Lead Product(s): D-Amphetamine Sulfate

            Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Public Offering October 23, 2020

            Details:

            The company's clinical-stage product currently under development is Abuse-Deterrent Amphetamine Immediate-Release, or ADAIR. ADAIR has completed a Phase 1 pivotal bioequivalence study and a Phase 1 food effect study.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102 SL

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 06, 2020

            Details:

            FDA has cleared the Investigational New Drug (IND) application for the initiation of a Phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder (AUD).

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            Lead Product(s): CVL-231

            Therapeutic Area: Psychiatry/Psychology Product Name: CVL-231

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: PIPE

            Deal Size: $445.0 million Upfront Cash: Undisclosed

            Deal Type: Financing July 30, 2020

            Details:

            Upon completion of the business combination, the net proceeds will be used to advance development of Cerevel Therapeutics’ diverse neuroscience pipeline, including potential treatments for schizophrenia, epilepsy, and Parkinson’s diseas.

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            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: INP105

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2020

            Details:

            Study shows INP105 achieves rapid absorption which may provide an effective, convenient, & noninvasive future alternative for treating acute agitation in the home, community, or hospital setting.