Information intended for UK healthcare professionals only.

This formulary decision guide was developed from content provided by Accord UK Ltd in a format developed by Guidelines in Practice. Please see bottom of the page for the full disclaimer.

View Zubsolv® (buprenorphine, naloxone) prescribing information

FINAL Zubsolv FDG front cover image

Key points:

  • Zubsolv®
    • doses contain less buprenorphine (BPN) compared with conventional BPN/naloxone (NLX) tablets due to improved bioavailability, which means that less BPN is available for parenteral abuse1–3
    • rapidly disintegrates, usually within 40 seconds, which may reduce the risk of diversion and supervision time[A] 1,3,4,5
    • is the patient preferred buprenorphine/naloxone treatment option, which may increase treatment compliance1,2,3
    • offers a wide sublingual tablet dosage range that provides greater flexibility and may reduce pill burden compared with Suboxone sublingual tablets1,4
    • combines buprenorphine, an opioid substitution medicine, with naloxone, to help deter parenteral abuse.4

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Drug name

Zubsolv® (buprenorphine, naloxone) 1.4 mg/0.36 mg; 2.9 mg/0.71 mg; 5.7 mg/1.4 mg; 8.6 mg/2.1 mg; 11.4 mg/2.9 mg sublingual tablets

Indication5  

  • Substitution treatment for opioid drug dependence, within a framework of medical, social, and psychological treatment
  • The intention of the naloxone component is to deter intravenous misuse
  • Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.

Dosage and administration

  • Zubsolv® is not interchangeable with other buprenorphine products, as different buprenorphine products have different bioavailability, therefore the dose in mg can differ between products—once the appropriate dose has been identified for a patient with a specific buprenorphine product, that product should not be exchanged with another product5
  • Zubsolv® is available in five different tablet strengths, supporting individual dose titration and tapering5
  • Zubsolv® has an extended dose range allowing individualised dosing and greater flexibility, and may permit patients to be treated with fewer tablets daily compared with conventional buprenorphine/naloxone tablets1,4
  • Zubsolv® has an improved buprenorphine absorption and bioavailability enabling a 30% lower buprenorphine dose to be used compared with a conventional sublingual tablet, while maintaining equivalent systemic exposure1–4
  • A benefit of the 30% lower buprenorphine dose that results from improved bioavailability, is that less buprenorphine is available for parenteral abuse and may reduce the risk of diversion4
  • Zubsolv® provides improved taste and mouth feel resulting in a higher preference when compared with conventional treatments, offering an additional treatment option to patients and clinicians managing opioid addiction1,5
  • The buprenorphine component of Zubsolv® relieves cravings in patients dependent on full µ-opioid agonists4
  • The addition of naloxone helps to deter abuse as it precipitates withdrawal symptoms when taken parenterally by opioid-dependent patients but has limited bioavailability and minimal systemic effects when administered sublingually.5

Clinical evidence

  • Zubsolv®’s formulation of buprenorphine with naloxone, allows for rapid tablet disintegration4
  • Zubsolv®’s sublingual dissolve time is significantly shorter than that of Suboxone® tablets, with the median perceived dissolve time of the 11.4 mg/2.9 mg dose on average 8.5 minutes compared with 16.2 minutes for the corresponding equivalent Suboxone® dose of 16 mg/4 mg1,3,4,5
  • Zubsolv®’s shorter dissolve times[A] are desirable to reduce supervision time, which may be stigmatising for patients and a cost burden1
  • In clinical trials, more patients preferred the taste of the Zubsolv® tablet compared with the Suboxone® tablet
  • Zubsolv® achieved a mean taste acceptability numeric rating scale (NRS) rating of 6.4 compared with 4.2 for Suboxone® (P<0.0001)3
  • Participants reported preferable taste and greater overall acceptability compared with the previously available buprenorphine/naloxone tablet, and preferable mouthfeel and less unpleasant aftertaste compared with sublingual buprenorphine/naloxone film1,3
  • Overall, 89% and 77% of participants preferred Zubsolv® over buprenorphine/naloxone film and the buprenorphine/naloxone tablet, respectively3
  • Although patient preference for various buprenorphine products have not yet been proven to influence clinical outcomes and prevent relapse, it has been suggested that enhancing patient experience may facilitate treatment engagement, this could influence retention in treatment2
  • Improved acceptability might be important for treatment compliance and adherence3
  • Enhancing patient experience with buprenorphine-based medication may increase treatment compliance1
  • This formulation offers the potential to improve treatment outcomes and local tolerability in patients with opioid dependence, and reduces the risk of diversion/abuse1
  • The increased bioavailability of Zubsolv® tablets compared with Suboxone® tablets may be due to a combination of features of the Zubsolv® formulation:
    • small tablet sizes
    • citric acid buffer system that promotes rapid tablet disintegration
    • micronised BPN particles.1

[A] It may take 5–10 minutes for the patient to feel complete tablet disappearance from the mouth.

Safety profile

  • The adverse events most commonly reported with Zubsolv® are symptoms associated with withdrawal and constipation
  • Very common adverse events (>1/10 patients) reported in Zubsolv® clinical trials and post-marketing surveillance are:
    • insomnia
    • headache
    • constipation
    • nausea
    • hyperhidrosis
    • drug withdrawal syndrome
  • Buprenorphine can be misused or abused in a manner similar to other opioids, legal, or illicit5
  • To minimise the risk of misuse, abuse, and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine.5

References

  1. Jonsson M et al Eur J Pharm Sci 2018; 122: 125–133.
  2. Gunderson E et al J Addict Med 2016; 10: 124–130.
  3. Fischer A et al Drug Dev Ind Pharm 2015; 41 (1): 79–84.
  4. Webster L et al J Addict Dis 2016; 35 (4): 325–338.
  5. Accord UK Ltd. Zubsolv (buprenorphine, naloxone) 0.7mg/0.18mg; 1.4mg/0.36mg; 2.9mg/0.71mg; 5.7mg/1.4mg; 8.6mg/2.1mg; 11.4mg/2.9mg Sublingual Tablets—summary of product characteristics. www.medicines.org.uk/emc/  (accessed 2 February 2022)

This formulary decision guide was developed from content provided by Accord UK Ltd in a format developed by Guidelines in Practice. It was commissioned by Accord UK Ltd, who carried out full medical approval to ensure compliance with regulations.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.  Adverse events should also be reported to Accord-UK LTD on 01271 385257 or email medinfo@accord-healthcare.com

UK-03738

Date of preparation: July 2022