The choice of an
advanced formulation

ZUBSOLV offers a preferred menthol flavor1

In an open-label, crossover study in 28 healthy volunteers*:

Significantly more subjects chose the menthol flavor of ZUBSOLV as their preferred taste over Suboxone® film.

  • 96.3% of subjects preferred the taste of ZUBSOLV over Suboxone film (P<0.0001)
  • Fewer subjects experienced an unpleasant aftertaste with ZUBSOLV (42.9%) compared with Suboxone film (92.6%)

ZUBSOLV dissolves fast1

In an open-label, crossover study in 28 healthy volunteers*:

The dissolve time of ZUBSOLV was similar to that of Suboxone film (P=0.232)

  • The median dissolve time was 2.88 minutes for both ZUBSOLV 5.7-mg/1.4-mg tablets and Suboxone 8-mg/2-mg film
  • 81.5% of subjects chose ZUBSOLV over Suboxone film for the preferred mouthfeel (P=0.0011)
In an open-label, comparative bioavailability study in 60 healthy volunteers:

ZUBSOLV demonstrated higher bioavailability with a lower tablet dose1

  • ZUBSOLV contains less buprenorphine than other buprenorphine/naloxone-containing sublingual tablets,
    but achieves similar systemic exposure

One 5.7-mg/1.4-mg tablet of ZUBSOLV provides equivalent buprenorphine
plasma concentration to one 8-mg/2-mg sublingual tablet of Suboxone®

Tablets not shown at actual size
  • The high bioavailability of ZUBSOLV allows for a low dose of buprenorphine and may reduce the potential for misuse and diversion

– The naloxone component of ZUBSOLV may reduce the potential for IV misuse and diversion

ZUBSOLV is a small sublingual tablet

Depending on screen size and magnification, tablets and film may not be actual size.
However, the relative sizes of the tablets and film are accurate.

  • One 5.7-mg/1.4-mg tablet of ZUBSOLV provides equivalent buprenorphine plasma concentration to one 8-mg/2-mg sublingual tablet for Suboxone1†

Switching to ZUBSOLV is easy

  • ZUBSOLV offers simple conversion from previous sublingual treatment
  • For patients being switched between ZUBSOLV and other buprenorphine/naloxone products, dosage adjustments may be necessary
  • Patients should be monitored for overmedication as well as withdrawal or other signs of under-dosing
*
Study design: Open-label, randomized, 2-period, crossover study in 28 healthy volunteers. Subjects received either ZUBSOLV sublingual tablet or Suboxone sublingual film under naltrexone block. ZUBSOLV sublingual tablets and Suboxone sublingual film were administered 36 hours apart in a randomized sequence. Tolerability, safety, and dissolve time were assessed. Acceptability and subject preference of drug product were evaluated by specific questioning.
 
Study design: Open-label, fasting, randomized, 2-period, crossover, comparative bioavailability study in 60 healthy volunteers. Subjects received either ZUBSOLV sublingual tablet or Suboxone sublingual tablet under naltrexone block according to a 2 sequence randomization schedule. Blood samples were collected at predose and at intervals over 72 hours after dosing each period. Pharmacokinetics, tolerability, safety, and dissolve time were assessed and acceptability and subject preference of drug product were evaluated by specific questioning.

Exposure is the concentration of buprenorphine detectable in the blood evaluated after dosing.

*Suboxone is a registered trademark of Reckitt Benckiser Healthcare (UK) Ltd.

Reference:

  1. Fischer A, Jönsson M, Hjelmström P. Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in healthy volunteers. Drug Dev Ind Pharm. 2013;1-6. DOI: 10.3109/03639045.2013.846365.