Sublocade: The Newest Breakthrough In Medication-Assisted Treatment (MAT)

Introduction to Sublocade Treatment

Sublocade is the first, once-monthly extended-release form of buprenorphine designed for subcutaneous injection only.1  It can be a life-changing medication for individuals recovering from opioid use disorders. It is essential for potential patients and their loved ones to learn the nuances of this medication and understand both its benefits and risks.

What Is Sublocade?

The FDA has approved Sublocade as an extended-release form of buprenorphine. The medication works by delivering small amounts of buprenorphine (at a controlled rate) throughout the month. This process maintains a sustained and consistent level of buprenorphine throughout the bloodstream.

Understanding Buprenorphine

Buprenorphine, the active ingredient in Sublocade, is a partial opioid agonist.² Partial opioid agonists can produce effects that somewhat mimic other opioids (respiratory depression, euphoria).  These effects, however, are significantly weaker than the effects experienced in full opioid agonists like heroin, pain relievers, or methadone.

Furthermore, if the individual increases the dosage of partial agonists, analgesic activity plateaus and the opposite effects (withdrawal symptoms) start to emerge.3  

In 2002, the FDA approved buprenorphine as part of a “whole-patient approach” to treat opioid dependence.4  They have since approved the following products: 4,5

• Suboxone: a film consisting of buprenorphine and naloxone)

• Zubsolv: sublingual tablets consisting of buprenorphine and naloxone

• Bunavil: a buccal film consisting of buprenorphine and naloxone Buprenorphine-containing transmucosal products

• Probuphine: a subcutaneous skin implant that releases buprenorphine for six months

Naloxone, the other main ingredient, is an opioid agonist. It is added to the medication to discourage intravenous abuse of buprenorphine. If misused by injection, the naloxone causes immediate withdrawal symptoms.5

Who Can Take Sublocade?

Sublocade is only available via prescription. The medication is currently subject to a risk evaluation and mitigation strategy (REMS). This refers to “restricted distribution” which essentially guarantees that only appropriate healthcare providers administer Sublocade2  

Sublocade is prescribed for people with a moderate or severe addiction to opioids like illicit substances, such as heroin, and prescription painkillers, such as Oxycontin, Percocet, and Vicodin.

Currently, it can be prescribed to people who:

• Have received treatment with an oral transmucosal buprenorphine medication (delivering the equivalent of 8-24 mg of buprenorphine daily) for seven days.

• Are currently taking a dose that monitors and controls withdrawal symptoms for at least seven days.³

Because Sublocade is incredibly new, the medical community is still examining who can (and should) receive prescriptions. There is no current research on initiating treatment with Sublocade as the first buprenorphine product in treating opioid use disorder.

How Is Sublocade Prescribed and Used?

Sublocade is currently available in 2 formulations: 100 mg/0.5 mL and 300 mg/1.5 mL.

Typically, the recommended dose starts at 300 mg for the first two months followed by a maintenance dose of 100 mg monthly.² The physician may increase the maintenance dose to 300 mg for individuals who do not clinically respond to the lower dose.

All doses need at least 26 days before the next dose. Patients who miss doses should arrange to receive the next one as soon as possible. While the occasional delay is not immediately problematic, it is critical to adhere to a consistent dosing schedule.

What Are The Side Effects?

Like all medications, there are several side effects to consider before taking Sublocade. Buprenorphine can cause severe, life-threatening issues if it interacts with other substances. These substances include:

• Alcohol.

• Muscle relaxants or sedatives.

• Antidepressants.

• Antihistamines.

• Sleeping pills or tranquilizers.

• Benzodiazepines.

Individuals should contact their physician immediately if they experience:

• Sudden mental health changes.

• Depressed breathing.

• Slurred speech.

• Problems with balance and coordination.

• Muscle stiffness.

• Increased body temperature.

• Profound feelings of dizziness.7

These symptoms could indicate an overdose or other concerning medical problems. To mitigate risk, patients must be honest and thorough with their healthcare providers during the initial assessment. This can help reduce the likelihood of adverse reactions.

Why Is Sublocade so Important?

America is in the midst of a devastating opioid epidemic ravaging families around the country. Every day, over 115 people die after overdosing on opioids. The CDC estimates that the economic burden associated with prescription opioid misuse alone costs nearly $80 billion annually.8

In the late 1990s, healthcare providers prescribed opioid pain relievers at record rates. At the time, pharmaceutical companies assured the medical community that these medications were safe and non-addictive.

Unfortunately, by 2015, more than 33,000 Americans had died as a result of opioid overdoses, and over 2 million people were actively struggling with an opioid use disorder.8

Medication-Assisted Treatment (MAT)

In response to this epidemic, healthcare professionals have devoted years to narcotic addiction research to determine effective substance treatment.

MAT refers to the umbrella notion of using FDA-approved medications to ease withdrawal symptoms, mitigate cravings, and support long-term recovery from problematic opioid use.

Currently, the most common medications are:

• Methadone

• Naltrexone

• Buprenorphine

Methadone: For several decades, designated clinics have provided the opioid, methadone, to treat other opioid addiction. This substance was initially prescribed for treating severe pain. Today, methadone is prescribed in pill, liquid, and wafer form and is taken once daily.

Treatment can last for several months to years depending on the individual. Individuals can only receive methadone at a specialized clinic. It cannot be prescribed by freestanding physicians or hospitals.9

Naltrexone: Naltrexone is an office-based, non-addictive opioid antagonist that blocks the effects of other narcotics. It is prescribed as a daily pill or as a monthly injection (called Vivitrol).

Naltrexone binds and blocks opioid receptors with the intention of reducing cravings. If a person relapses and uses opioids or alcohol, the naltrexone prevents him or her from getting high.10  Unlike methadone, most healthcare clinics and physicians can prescribe naltrexone.

While all three medications can be useful in opioid use disorder treatment, most facilities now use naltrexone and buprenorphine instead of methadone.

Buprenorphine Misuse Potential

Because buprenorphine produces opioid effects, it can be habit-forming. Drug users may, for example, take more than their prescribed amount. Alternatively, they may crush and inject sublingual tablets to achieve the desired effect.

Furthermore, if an individual decides to reduce or abstain from buprenorphine, he or she will experience withdrawal symptoms similar to other opioids that may include:

• Increased agitation and irritability.

• Anxiety and panic.

• Sweating and flushing.

• Abdominal cramping and bloating.

• Diarrhea and gastrointestinal discomfort.

• Dilated pupils.

• Vomiting.

While these symptoms may feel highly distressing, they are not life-threatening. That said, it is important to consult with a healthcare professional before stopping any opioid.

Sublocade Efficacy Rates

As mentioned, Sublocade is very new in the treatment realm. As more research emerges, there will be more of a firmer stance on the medication’s results and efficacy.

In a recent study, Sublocade was evaluated in a 24-week examination with patients randomized into three groups. One group received six, once-monthly Sublocade 300 mg doses. The second group received two, once-monthly Sublocade 300 mg doses followed by four, once-monthly 100 mg doses. The third group received six, once-monthly placebos. Both Sublocade regimens were clinically superior to the placebo regarding the measurement of opioid abstinence.11

Sublocade Costs

According to Indivior, the producer of Sublocade, the wholesale acquisition cost is $1580 per monthly dose. However, they also offer a co-pay assistance program that can reduce initial out-of-pocket costs for eligible patients for $5 each month.11

Final Thoughts

Sublocade appears to be a promising agent in the field of addiction treatment. With opioid rates continuing to soar in recent years, it is more important than ever to continue providing evidence-based options for medical care.

References

1. Sublocade. Sublocade: Keep Moving Towards Recovery.

2. Pharmacy Times. (2018).

3. Pharmacy Times. (2018).

4. Substance Abuse and Mental Health Services Administration. (2016). Buprenorphine.

5. The National Alliance of Advocates for Buprenorphine Treatment. What exactly is Buprenorphine?

6. U.S National Library of Medicine. (2018). Opiate and opioid withdrawal.

7. Sublocade. FAQs.

8. National Institute on Drug Abuse. (2018). Opioid Overdose Crisis.

9. Substance Abuse and Mental Health Services Administration. (2015). Methadone.

10. Substance Abuse and Mental Health Services Administration. (2016). Naltrexone.

11. Indivior UK Limited. Sublocade.