What Is Brixadi and What Is Its Approved Use?
Brixadi is an extended-release injectable medication containing buprenorphine. As a partial opioid agonist, buprenorphine works by binding to opioid receptors in the brain, but with less intensity than full opioid agonists like heroin or oxycodone. This action helps to reduce cravings and withdrawal symptoms in individuals recovering from opioid addiction.
Unlike other buprenorphine products, Brixadi is a long-acting injectable (LAI) administered by a healthcare provider either weekly or monthly. The FDA approved Brixadi in 2023 exclusively for the treatment of moderate to severe opioid use disorder (OUD). It is intended for patients who are either starting buprenorphine treatment with a test dose of another formulation or are already on buprenorphine.
The Difference Between Buprenorphine for OUD and Pain
While the active ingredient in Brixadi, buprenorphine, can be used for pain, it is crucial to understand the difference in purpose and formulation. The prescribing information for Brixadi explicitly states that it is not approved for pain relief. The reason for this distinction is multifaceted, involving different treatment goals, dosage strategies, and safety considerations.
Formulations for Chronic Pain
For chronic pain management, buprenorphine is available in different formulations specifically approved by the FDA for that purpose. These include:
- Butrans: A transdermal patch applied to the skin once a week for around-the-clock management of moderate to severe chronic pain.
- Belbuca: A buccal film (dissolves in the cheek) used for around-the-clock management of moderate to severe chronic pain.
- Buprenex: An injectable form used for acute or short-term pain, not the extended-release type found in Brixadi.
Dosage Differences
One of the main reasons Brixadi is not used for pain is the significant difference in dosing. The doses used for OUD are typically much higher than those for chronic pain. While treating OUD focuses on managing cravings and withdrawal, pain management aims to improve function and quality of life at the lowest possible effective dose. The long-acting, higher doses of Brixadi are specifically designed for the needs of OUD treatment, not pain control.
Potential Risks of Using Brixadi for Chronic Pain
Using a medication for a purpose other than its FDA-approved indication, known as “off-label” use, comes with serious risks. For Brixadi, these risks include:
- Risk of Overdose: Combining buprenorphine with other central nervous system depressants, like alcohol or benzodiazepines, can cause life-threatening breathing problems and potential death.
- Misuse and Dependence: As a Schedule III controlled substance, Brixadi has the potential for misuse, abuse, and dependence. It is available only through a restricted program called the Brixadi REMS Program to mitigate these risks.
- Intravenous (IV) Administration: Brixadi carries a Boxed Warning for the risk of serious harm or death if administered intravenously, as the depot can cause local tissue damage and blockages in the lungs. This is why it is only administered by a healthcare provider.
Comparison of Buprenorphine Formulations for Pain vs. OUD
| Feature | Brixadi (Injectable) | Butrans (Transdermal Patch) | Belbuca (Buccal Film) |
|---|---|---|---|
| FDA-Approved Use | Moderate to severe opioid use disorder (OUD) | Moderate to severe chronic pain | Moderate to severe chronic pain |
| Administration | Subcutaneous injection by healthcare provider | Skin patch worn continuously for 7 days | Film that dissolves in the cheek |
| Dosing Frequency | Weekly or monthly | Once every 7 days | Twice daily |
| Primary Goal | Reduce cravings and withdrawal symptoms for OUD | Provide consistent pain relief over time | Provide consistent pain relief over time |
| Key Differences | Higher dosage ranges, administered in a clinical setting, restricted via REMS | Lower doses, steady-state delivery, patient-administered | Lower doses, steady-state delivery, patient-administered |
Conclusion
In summary, Brixadi is a powerful tool in the treatment of opioid use disorder, with its extended-release formulation designed to help manage addiction over time. However, due to its specific FDA approval and safety profile, it is not an appropriate medication for treating chronic pain. Patients with chronic pain should work with their healthcare providers to explore the appropriate buprenorphine formulations or other multimodal pain control strategies that are proven effective for their condition. Attempting to use a medication for an unapproved purpose, especially a potent opioid like buprenorphine in a high-dose injectable form, can pose significant and unnecessary health risks. For more in-depth information, resources from the U.S. Department of Veterans Affairs offer guidelines on the appropriate use of buprenorphine for pain management.
Important Discussion with a Healthcare Provider
Before beginning or changing any pain management plan, a comprehensive discussion with a healthcare provider is essential. They can evaluate your specific needs and medical history to recommend the safest and most effective treatment path. This is especially important for patients who have been on long-term opioid therapy, as transitioning to or initiating any buprenorphine treatment requires careful medical supervision.
