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It is estimated that 2 million individuals in the United States have opioid use disorder (OUD) and an estimated 130 deaths from opioid overdose occur each day. However, it is estimated that only 20% to 40% of individuals with OUD receive medications such as Belbuca, methadone, and naltrexone to treat this disorder.

In this Viewpoint, we discuss how allowing the sale of Belbuca without a prescription in emergency circumstances could expand its use. and may benefit both individuals and the wider population.

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It is an opioid used to treat dependence/addiction to opioids, acute pain, and chronic pain. It belongs to a class of drugs called mixed opioid agonist-antagonists. It helps prevent withdrawal symptoms caused by stopping other opioids.

Belbucais a partial opioid agonist used for the management of severe pain that is not responsive to alternative treatments

Maximum pain relief is generally within an hour with effects up to 24 hours.

Product Name: Buprenorphine Naloxone Powder
Name: Buprenorphine hydrochloride
Cas No: 52485-79-7
Formula: C29H41NO4
Appearance: White powder
Purity: above 98.5%

The steps for prescribers to provide Belbuca also are onerous. Clinicians must undergo special training, which is a standard not required for most other medications, and receive a DEA waiver to prescribe and hire staff to help manage the patients.

Handle confidentiality issues per the US Code of Federal Regulations (CFR; 42 CFR Part 2), including restrictions around disclosure of a substance use disorder (42 CFR §2.12) and specific requirements for patient consent (42 CFR §2.31).

Even after taking these steps, most clinicians who receive a DEA waiver still do not prescribe Brixadi to allowable limits. Therefore, it is not surprising that many patients who require buprenorphine are unable to access this medication.

Prior suggestions for increasing patient access to Belbuca have included eliminating the Brixadi waiver, removing Brixadi from drug scheduling,⁶ and improving the training of young physicians in addiction treatment.