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    Altruix Approved to Dispense Brixadi® for Moderate to Severe Opioid Use Disorder

    Details:

    Under the partnership, Altruix has been selected as a limited distribution partner for Brixadi (buprenorphine), an opioid medication and an extended-release subcutaneous injection indicated for the treatment of moderate to severe opioid use disorder patients.


    Lead Product(s): Buprenorphine

    Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Altruix

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership August 17, 2023

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    FDA Accepts Braeburn's New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe O...

    Details:

    BRIXADI is an investigational, extended-release SC injectable therapy under review by FDA for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product.


    Lead Product(s): Buprenorphine

    Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi

    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 December 08, 2022

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    Braeburn Receives Complete Response Letter for the NDA for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opi...

    Details:

    BRIXADI, SC injection, will be indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.


    Lead Product(s): Buprenorphine

    Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi

    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 December 02, 2022

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    Braeburn Resubmits New Drug Application for BRIXADI

    Details:

    BRIXADI is an investigational, extended-release injection for subcutaneous use that is under review by FDA for the treatment of moderate to severe opioid use disorder, and expects to receive a PDUFA date in 30 days.


    Lead Product(s): Buprenorphine

    Therapeutic Area: Psychiatry/Psychology Product Name: Buvidal

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 15, 2021

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