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

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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): Dextroamphetamine

            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.

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            Lead Product(s): Ketamine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: SLS-002

            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 23, 2020

            Details:

            SLS-002 Was Safe and Well Tolerated Across All Doses with Resolution of Expected Group Mean Dissociative Side-Effects That Occurred in the Higher Dose Groups Within One Hour.

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            Lead Product(s): Risperidone

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            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 10, 2020

            Details:

            Lyndra Therapeutics completed enrollment and dosing of its Phase I clinical trial for an ultra-long-acting oral risperidone therapy to treat schizophrenia, ramping up manufacturing capabilities and growing its employee base by 28%.

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            Lead Product(s): Tolperisone

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            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 May 12, 2020

            Details:

            The publication reports results from the Phase 1, threeway, randomized, blinded, three-period crossover study that evaluated cyclobenzaprine in neuromuscular conditions.

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            Lead Product(s): CAD-9303

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Cowen Healthcare Investments

            Deal Size: $15.0 million Upfront Cash: Undisclosed

            Deal Type: Series B Financing April 29, 2020

            Details:

            The Company plans to allocate all proceeds to continue development for its lead cognitive disorder asset, CAD-9303 for the treatment of the cognitive deficits and negative symptoms of schizophrenia.

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