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Buprenorphine-based therapies

Psychiatryยท 4 reviewed drugsยท 907 cited findings behind them

What the regulatory reviews cover

This library includes several buprenorphine-based therapies that have undergone regulatory review. Buvidal is indicated for the treatment of opioid dependence in adults and adolescents aged 16 years or over, within a framework of medical, social, and psychological treatment. Sublocade is indicated for the treatment of moderate to severe opioid use disorder (OUD) in patients who have undergone induction to suppress opioid withdrawal signs and symptoms with a transmucosal buprenorphine-containing product. Brixadi is indicated for the treatment of moderate opioid use disorder. The indication for Zubsolv is not provided in the available material.

Regulatory reviews for these therapies report various outcomes. For Buvidal, the overall median cumulative percent urine samples negative for illicit opioids (CAM2038) was 26.7%, compared to 6.7% for SL BPN/NX. Sublocade demonstrated a treatment success rate (responder) of 28%-29%, with a P-value for difference between RBP-6000 dosing regimens and placebo of <0.0001. Brixadi showed a responder rate (CAM2038) of 16.9% versus 13.9% for SL BPN/NX, with a non-inferiority P-value of < 0.001. For Zubsolv, the retention in treatment (difference vs Suboxone) was 0.5%. It is important to note that these figures are derived from different trials and are not directly comparable head-to-head.

The drugs โ€” one cited result each

Buvidal

Camurus

overall median cumulative percent urine samples negative for illicit opioids (CAM2038): 26.7%

Camurus โ€” Buvidal EMA EPAR public assessment report (EMEA/H/, p.77

Sublocade

Indivior PLC

Treatment success rate (responder): 28 %-29 %

Indivior PLC โ€” Sublocade FDA Review (NDA209819, ORIG 1, 2017, p.12

Brixadi

Braeburn

Responder rate (CAM2038): 16.9%

Braeburn โ€” Brixadi FDA Review, p.10

Zubsolv

Accord S L U

Retention in treatment (difference vs Suboxone): 0.5%

Accord S L U โ€” Zubsolv EMA EPAR public assessment report (EM, p.32

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Psychiatry research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Buprenorphine-based therapies โ€” 4 Drugs Compared from FDA & EMA Reviews | BioPharmaPT Psychiatry