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Harm Reduction Therapeutics
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4800 Montgomery Ln, Ste 400, Bethesda, Maryland, 20814
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RiVive (naloxone HCl nasal spray) is an FDA approved, over-the-counter (OTC) medication which is indicated for the emergency treatment of opioid overdose.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: RiVive

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 20, 2023

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RiVive (naloxone HCl) is a μ opioid receptor antagonist. It is an FDA-approved, over-the-counter medication approved for the emergency treatment of opioid overdose.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: RiVive

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 20, 2023

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RiVive™ (Naloxone HCl Nasal Spray 3 mg) an opioid antagonist to be available over the counter (OTC) for the emergency treatment of life-threatening opioid overdose.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Rivive

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 01, 2023

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Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™, for the emergency treatment of known or suspected opioid overdose.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Rivive

Highest Development Status: Phase IIIProduct Type: Small molecule

Recipient: Catalent Pharma Solutions

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement March 23, 2023

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The proceeds will be used to fund commercial readiness for HRT’s low-cost over-the-counter (OTC) intranasal naloxone spray, tradename RiVive. Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Rivive

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Purdue Pharma

Deal Size: $29.9 million Upfront Cash: Undisclosed

Deal Type: Financing March 21, 2023

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RiVive is an intranasal formulation of naloxone (3.0 mg) delivered as an atomized spray (0.1 ml) using a standard unit dose system for single administration.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: RiVive

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 26, 2022

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Revive (naloxone hydrochloride) is a safe and effective opioid antagonist, originally approved by the FDA in 1971 and has been used for decades by both medical professionals and the lay public to successfully reverse opioid overdoses.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Revive

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 11, 2022

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Under its terms, the contract manufacturer will produce Harm Reduction Therapeutics' nasal spray, RiVive™ (3.0mg naloxone), for the emergency treatment of known or suspected opioid overdose.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Revive

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 11, 2022

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The additional funding approved today will help HRT continue its work toward making OTC naloxone nasal spray available to the public. HRT plans to file a New Drug Application for naloxone nasal spray with FDA in 2022.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Revive

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Purdue Pharma

Deal Size: $17.5 million Upfront Cash: Undisclosed

Deal Type: Financing March 23, 2022

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HRT001 is an intranasal formulation of naloxone (3.0 mg) delivered as an atomized spray (0.1 ml) using a standard unit dose system for single administration. Its tentatively approved tradename is RiVive™.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: RiVive

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Sage Chemical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 01, 2022

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