The Evolution of Buprenorphine Treatment
In 2002, the Food and Drug Administration (FDA) approved two buprenorphine products for treating opioid dependency: Subutex, which contained buprenorphine alone, and Suboxone, a combination of buprenorphine and naloxone. Subutex was administered as a sublingual tablet, dissolving under the tongue to manage opioid withdrawal symptoms and reduce cravings. However, concerns arose over the potential for individuals to misuse the tablet by crushing and injecting it for a high. In response, the manufacturer eventually discontinued the brand-name Subutex in 2011, promoting the use of the combined Suboxone formulation as a safer alternative.
The inclusion of naloxone acts as a built-in safety mechanism. When Suboxone is taken as prescribed, sublingually, the naloxone is poorly absorbed and has no effect. However, if the medication is crushed and injected, the naloxone becomes active and precipitates immediate, uncomfortable withdrawal symptoms, effectively deterring potential misuse. This innovation made buprenorphine treatment safer and more suitable for outpatient, at-home use.
Current Buprenorphine-Only Formulations
Despite the discontinuation of the Subutex brand, buprenorphine without naloxone is still very much in production today, primarily in two forms for opioid use disorder (OUD) treatment:
- Generic Sublingual Tablets: The generic versions of Subutex (buprenorphine-only tablets) are still available by prescription. Their use is often reserved for specific medical circumstances where the addition of naloxone is not appropriate or necessary.
- Extended-Release Injections: Modern, long-acting injectable formulations like Sublocade and Brixadi contain only buprenorphine, delivered via a subcutaneous injection administered monthly by a healthcare provider. Because these injections are administered in a clinical setting and not taken home, the abuse-deterrent naloxone component is not required. These injections are often used for maintenance treatment after a patient has been stabilized on an oral buprenorphine product.
Specific Medical Use Cases for Buprenorphine-Only
The prescription of buprenorphine without naloxone is carefully managed and restricted to situations where its benefits outweigh the risks. Key use cases include:
- Pregnancy: Buprenorphine-only formulations are often the preferred choice for treating pregnant patients with OUD. While studies suggest naloxone is safe in pregnancy, buprenorphine-only is often prescribed to mitigate any potential risk, no matter how small, and is associated with better infant outcomes compared to methadone.
- Induction Phase: In some cases, clinicians may use buprenorphine-only products during the initial induction phase of treatment, especially when there is a risk of precipitated withdrawal from other opioids. Once stable, patients can often transition to the safer buprenorphine/naloxone combination.
- Pain Management: Buprenorphine is also approved for the treatment of moderate to severe chronic pain and is available in formulations without naloxone, such as the Butrans transdermal patch and the Belbuca buccal film. These forms deliver the medication continuously over time, offering a safer alternative to full opioid agonists for chronic pain relief.
Buprenorphine Formulations for OUD: Comparison Table
| Feature | Buprenorphine-Only (Generic Subutex, Sublocade) | Buprenorphine/Naloxone (Suboxone, Zubsolv) |
|---|---|---|
| Active Ingredients | Buprenorphine only | Buprenorphine and naloxone (in a 4:1 ratio for Suboxone) |
| Primary Purpose | OUD induction (short-term) or maintenance (long-acting injections) | OUD maintenance treatment (long-term) |
| Administration | Sublingual tablet or long-acting subcutaneous injection | Sublingual film, sublingual tablet, or buccal film |
| Misuse Deterrent | Minimal or none with oral versions; high with injectable versions | Naloxone component causes withdrawal if injected |
| Typical Use Case | Reserved for pregnancy, induction, or controlled, supervised settings | Standard outpatient treatment for most OUD patients |
| Availability | Generic oral tablets still available; brand name discontinued | Widely available as both brand and generic formulations |
Access and Safety Considerations
For the majority of individuals receiving treatment for OUD, the combination of buprenorphine and naloxone is the safest and most appropriate option. The inclusion of naloxone provides a critical safeguard against misuse and diversion, protecting not only the patient but also the community from potential harm. It reduces the risk of someone crushing the medication to inject it, which could lead to an overdose or precipitate withdrawal symptoms.
However, for the specific patient populations and medical situations outlined above, buprenorphine-only formulations are essential tools. Their use is typically under strict medical supervision, especially in the case of long-acting injections that are administered in a clinical setting. The prescribing decision is made by a qualified healthcare professional who considers the patient's full medical history, treatment needs, and risk factors.
Conclusion
In summary, the answer to "do they still make buprenorphine without naloxone?" is a definitive yes, but with important context. The landscape has shifted away from the widely available Subutex brand, but buprenorphine-only is still manufactured in generic oral forms and modern, long-acting injectable options like Sublocade for OUD, as well as specific formulations for chronic pain. These products are not intended for widespread outpatient use due to their higher misuse potential, and their prescription is limited to specific clinical scenarios like pregnancy or supervised settings. For most patients, the buprenorphine/naloxone combination remains the standard of care, offering an effective and abuse-deterrent pathway to recovery. Navigating this distinction is crucial for both healthcare providers and patients to ensure safe and effective treatment for opioid use disorder and chronic pain. Learn more about FDA-approved medications for opioid use disorder on the official FDA website.
