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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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