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Find Psychiatry/Psychology Drugs in Phase I Clinical Development

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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.

            Liechti Lab

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            Lead Product(s): Psilocybine

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Mind Medicine

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration September 24, 2020

            Details:

            As part of this exclusive license agreement MindMed will retain an exclusive license to all IP and any patents generated from data or findings in the study and related work on psilocybin, such as pharmacokinetic data and information on the metabolism.

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            Lead Product(s): ASP8062

            Therapeutic Area: Psychiatry/Psychology Product Name: ASP8062

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: National Institutes of Health

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Funding September 22, 2020

            Details:

            Should the phase 1 studies demonstrate appropriate safety measures, a second phase of the grant may be awarded to help fund a randomized double-blind phase 2 study to assess the safety and efficacy of ASP8062 on the reduction of opioid use in OUD patients.

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            Lead Product(s): Psilocybine

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: University of Wisconsin-Madison

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

            Details:

            Revive Therapeutics is developing its tannin-chitosan composite of orally dissolvable thin films which offers a unique delivery platform for therapeutic doses (1-20mg) of psilocybin into the oral cavity.

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            Lead Product(s): Amisulpride

            Therapeutic Area: Psychiatry/Psychology Product Name: LB-102

            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 September 14, 2020

            Details:

            LB-102 was well-tolerated up to 150 mg/day. Plasma concentrations of LB-102 were ~2.5 times greater than published values of amisulpride at the same dose, suggesting LB-102 could be dosed substantially lower than amisulpride.

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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): ASP8062

            Therapeutic Area: Psychiatry/Psychology Product Name: ASP8062

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: National Institutes of Health

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Funding July 22, 2020

            Details:

            This NIH grant will help fund Astellas's two phase 1 clinical studies to evaluate the safety and efficacy of ASP8062, an oral small molecule GABAB receptor Positive Allosteric Modulator (PAM), as an add-on maintenance therapy for Opioid Use Disorder (OUD).

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            Lead Product(s): Nalmefene

            Therapeutic Area: Psychiatry/Psychology Product Name: OX125

            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:

            The study was a cross-over, comparative bioavailability study in healthy volunteers to assess nalmefene absorption from three development formulations of OX125, Orexo's wholly-owned nasal nalmefene product, compared to a nalmefene intramuscular injection.

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