Introducing ZUBSOLV sublingual tablets
Evolv
to an advanced formulation

In 2 open-label, crossover studies in healthy volunteers, ZUBSOLV demonstrated*:

Preferred menthol flavor1

  • Significantly more subjects preferred the taste of ZUBSOLV over Suboxone® sublingual tablet and Suboxone sublingual film (P<0.0001)

– Fewer than half (42.9%) of subjects experienced an unpleasant aftertaste
   from ZUBSOLV tablets compared to 92.6% for Suboxone

– 81.5% of subjects preferred the mouthfeel of ZUBSOLV tablets
   over Suboxone film (P=0.0011)

Fast dissolve time1

ZUBSOLV dissolved within minutes—significantly faster than Suboxone sublingual tablets (P<0.0001)1*

  • Median dissolve time of ZUBSOLV 5.7 mg/1.4 mg was 5 minutes vs 12.5 minutes for Suboxone 8-mg/2-mg tablet1

Higher bioavailability with a lower tablet dose1*

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

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

Depending on screen size and magnification, tablets may not be actual size.
However, the relative sizes of the tablets are accurate.
  • The higher bioavailability of ZUBSOLV allows for a lower dose of buprenorphine and may help 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 ZUBSOLV 5.7-mg/1.4-mg tablet provides equivalent buprenorphine plasma concentration to one Suboxone 8-mg/2-mg tablet1*
  • For patients being switched between ZUBSOLV sublingual tablets and other buprenorphine/naloxone products dosage adjustments may be necessary
  • Patients should be monitored for over-medication as well as withdrawal or other signs of under-dosing

*Study design: open-label, fasting, randomized, 2-period, crossover, comparative bioavailability study in 60 healthy volunteers. Subjects received
*ZUBSOLV and Suboxone tablet in a randomized sequence 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.

Study design: open-label, randomized, 2-period, crossover study in 28 healthy volunteers. Subjects received ZUBSOLV and Suboxone sublingual film
in a randomized sequence under naltrexone block according to a 2-sequence randomization schedule. ZUBSOLV sublingual tablets and Suboxone
sublingual film were administered 36 hours apart in a randomized sequence. 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. J├Ânsson M, Fischer A, Tiberg C, et al. A novel buprenorphine/naloxone tablet formulation for the treatment of opioid dependence. Poster presented at: 44th Annual Medical-Scientific Conference of the American Society of Addiction Medicine; April 25-28, 2013; Chicago, IL.