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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): 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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