ISSUE1427
A new sublingual tablet formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Zubsolv – Orexo) has been approved by the FDA for maintenance treatment of opioid dependence. Zubsolv tablets have relatively greater bioavailability than previously approved sublingual film (Suboxone) and sublingual tablet formulations of buprenorphine/naloxone and, according to an open-label survey, they taste better. The new tablets are smaller and dissolve faster than other tablet formulations, and they are individually sealed in child-resistant packaging.1
Buprenorphine is a Schedule III controlled substance that can be prescribed in an office setting by qualified physicians who register with the Substance Abuse and Mental Health Services Administration.2
Zubsolv is available as triangular tablets containing 1.4 mg of buprenorphine and 0.36 mg of naloxone and round tablets containing 5.7 mg of buprenorphine and 1.4 mg of naloxone, which achieve plasma concentrations of buprenorphine equivalent to those with the 2/0.5-mg and 8/2-mg strengths of other buprenorphine/naloxone tablets. A package of Zubsolv 5.7/1.4-mg tablets costs the same ($211) as a box of Suboxone 8/2-mg films. A bottle of generic buprenorphine/naloxone 8/2-mg tablets costs $250.3
1. A Fischer et al. Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in healthy volunteers. Drug Dev Ind Pharm 2013 Oct 7 (epub).
2. Buprenorphine: an alternative to methadone. Med Lett Drugs Ther 2003; 45:13.
3. Approximate wholesale acquisition cost (WAC) of 30 tablets or films. Source: $ource® Monthly (Selected from FDB MedKnowledge™) October 5, 2013. Reprinted with permission by FDB, Inc. All rights reserved. ©2013. www.fdbhealth.com/policies/drug-pricing-policy. Actual retail prices may be higher.
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