Indra Cidambi, M.D.

Sure Recovery

Sublocade: Directionally Positive But Not a Panacea

Various hurdles to overcome for wide adoption of injectable buprenorphine.

Posted Dec 01, 2017

The Food & Drug Administration (FDA) announced its approval of an injectable form of buprenorphine (brand name: Sublocade), a medication used to treat opiate addiction. Sublocade releases a steady dose of buprenorphine for one month. Buprenorphine works by reducing cravings and withdrawal symptoms and Sublocade is recommended for patients stabilized on a steady, maintenance dose of buprenorphine for seven days.

Sublocade offers important benefits not currently provided by the sublingual form of buprenorphine. Medication is steadily released into the blood stream, which helps patients to be compliant with the regimen, and diversion is a non-issue. It could truly help individuals seeking longer-term maintenance treatment for Opiate Use Disorder. However, prescribers should be careful to introduce Sublocade after patients have completed the early stage of treatment (3 phases) where therapy, to effect life style changes needed to maintain long-term sobriety, is a major component. Co-abuse of other drugs while on this medication and DEA regulations are also issues.

Introducing Sublocade in the early stage of treatment may backfire: The early stage of treatment consists of detoxification (the most acute phase), followed by partial care and intensive outpatient programs – lasting a total of 3-4 months. During these phases, group and individual therapy, focused on relapse prevention and coping skills, is a major component of treatment coupled with medication. For opioid use disorder, buprenorphine is introduced in higher doses during the detoxification stage and later tapered to settle at a maintenance dose. Introducing Sublocade in the early stage of treatment could jeopardize the recovery process. The patient may need frequent dose adjustment that Sublocade cannot deliver and the patient may turn to licit or illicit drugs to satiate unaddressed cravings and/or withdrawal symptoms. Or, it could demotivate the patient from engaging in therapy, as there is a month’s worth of supply in the system, relative to receiving a week’s worth of prescription at a time.

Abuse of other drugs while on Sublocade not unlikely: When a patient is switched to Sublocade (injectable buprenorphine) the prescriber should be mandated to perform a drug screen on the patient before administering the next dose. Co-abuse of other classes of drugs, such as benzodiazepines, along with buprenorphine has the same effect as using opiates and benzodiazepines together – i.e. increased risk of respiratory depression. As per NCBI, co-abuse of benzodiazepines and opiates increased by 570% from 2000 to 2010. Use of alcohol along with buprenorphine is also contraindicated. Also, many of my patients have reported that they are less concerned with abusing Fentanyl while on Suboxone (sublingual form of buprenorphine), as the naloxone in the medication reduces the chances of overdose. Consequently, a dirty urine is a serious issue and should not be ignored. The patient should be asked to engage in a higher level of treatment for increased support, as it is evidence that the patient is still struggling.

Logistics and DEA regulations may deter prescribers: Sublocade will likely be distributed under a ‘closed distribution system.’ This means that the manufacturer/specialty pharmacy will ship the product directly to buprenorphine prescribers and they will inject it in their office. The providers will have to store the injectable buprenorphine (a controlled substance under the purview of the DEA) in their offices and implement an inventory accounting system to satisfy DEA regulations. Unless there is a special waiver, the DEA requires practitioners to utilize a ‘TL-15’ rated safe to store controlled substances (costs a few thousand dollars) and install alarms and cameras for security. Additionally, prescribers will now be subject to unannounced visits by the DEA to ensure compliance. The cumbersome responsibility of storing the medication and additional paperwork could be a strong deterrent to providing the injection.

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