The Times Herald

Braeburn Resubmits New Drug Application for BRIXADITM (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

PLYMOUTH MEETING, Pa., June 15, 2021 /PRNewswire/ — Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) ...
Monthly Prescribing Reference

Buprenorphine Extended-Release SC Injection Under Review Again for Opioid Use Disorder

Credit: Getty Images. The resubmitted NDA was in response to a Complete Response Letter issued by the FDA in December 2021. The Food and Drug Administration (FDA) has accepted the resubmitted New Drug ...
Healio

FDA approves extended-release buprenorphine injection for opioid use disorder

Please provide your email address to receive an email when new articles are posted on . Brixadi is the first long-acting buprenorphine injectable that is available in weekly and monthly doses.
ksn.com

Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder

BRIXADI is the first and only long-acting buprenorphine injectable with both weekly and monthly doses. Patients currently on a transmucosal buprenorphine-containing product can be switched to an ...
ksn.com

BRIXADI® (buprenorphine) Extended-Release Injection for Subcutaneous Use (CIII) is Now Available in the U.S. for the Treatment of Moderate to Severe Opioid Use Disorder

BRIXADI is now available for healthcare settings and pharmacies through a restricted distribution program called the BRIXADI REMS and is administered only by a healthcare professional. PLYMOUTH ...
Healio

Subcutaneous buprenorphine effective in curbing cravings, easing withdrawal in OUD

Please provide your email address to receive an email when new articles are posted on . The study included 227 individuals with OUD given CAM2038 either on weekly or monthly basis. The treatment was ...
Seeking Alpha

New publication shows effectiveness data for weekly and monthly buprenorphine injections in treating opioid dependence in individuals using fentanyl

LUND, Sweden, June 25, 2024 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced the publication in JAMA Network Open of a new post hoc analysis from a 24-week randomized, double-blind, Phase 3 ...
Animal Welfare Institute

Haertel, A. J., Schultz, M. A., Colgin, L. M. et al. 2021. Predictors of subcutaneous injection site reactions to sustained-release buprenorphine in rhesus macaques (Macaca ...

Subcutaneous injection site reactions to sustained-release buprenorphine hydrochloride (Buprenorphine SR) in macaques have been reported in only a single case report. In the current study, we ...
Daily Local News

FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADITM (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

PLYMOUTH MEETING, Pa., June 26, 2021 /PRNewswire/ — Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injection for subcutaneous ...
Medscape

FDA Approves Buprenorphine Injection for Opioid Use Disorder

The US Food and Drug Administration (FDA) has approved extended-release injection buprenorphine (Brixadi, Braeburn Inc) for the treatment of moderate to severe opioid use disorder (OUD). The ...
Monthly Prescribing Reference

FDA to Review Buprenorphine Extended-Release Injection for Opioid Use Disorder

Credit: Getty Images. Brixadi (buprenorphine) is an investigational, extended-release weekly and monthly subcutaneous injection for moderate to severe opioid use disorder. The Food and Drug ...