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ZUBSOLV.


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ZUBSOLV, an advanced formulation for the
treatment of opioid dependence. Call 855-982-7658 for more information.

 

The results are in and patients prefer ZUBSOLV® to Suboxone® film.1

More than 70% of patients preferred ZUBSOLV attributes such as taste, mouthfeel, and ease of administration when compared to Suboxone film.

70%

Taste & Mouthfeel

72%

Ease of Administration

ZUBSOLV showed comparable retention at Day 15 vs Suboxone film (74.9% vs 74.4%)1


ZUBSOLV showed comparable retention at Day 15 vs Suboxone film

ZUBSOLV
0%
Suboxone film
0%

Withdrawal Symptoms (COWS)1

ZUBSOLV
0
Suboxone film
0

COWS = Clinical Opiate Withdrawal Scale. COWS is measured on a scale of 0-48 where a lower score is favorable. Note: Numbers are due to rounding.

Opioid Cravings (VAS)1

ZUBSOLV
0
Suboxone film
0

VAS = Visual Analog Scale.  VAS is measured on a scale of 0-100 where a lower score is favorable. Note: Numbers are due to rounding.

Adverse events were similar across treatments. See the full study results.


Adverse events were similar across treatments1

Treatment-related, treatment-emergent adverse events (TEAEs) in ≥2% of patients Day 3 through Day 15 by system organ class (safety population)


System Organ Class

  • Patients with any TEAEs

  • Gastrointestinal disorders
  • Constipation
  • Nervous system disorder
  • Headache

ZUBSOLV

  • 42 (11.8%)

  • 22 (6.2%)
  • 10 (2.8%)
  • 12 (3.4%)
  • 5 (1.4%)

Suboxone film

  • 37 (10.8%)

  • 18 (5.2%)
  • 12 (3.5%)
  • 12 (3.5%)
  • 7 (2.0%)

The percentages of patients with treatment-related TEAEs were similar between the 2 treatments (post Day 3 through Day 15, 11.8% versus 10.8% for ZUBSOLV and Suboxone film, respectively)

  • Gastrointestinal effects were minimal with constipation reported in <5% of patients in the study. Similar improvements were demonstrated in constipation symptoms from baseline to Day 15 in both groups.
  • Nervous system disorders were similar between groups, all were mild to moderate in severity with headache being the most commonly reported event

97% of treatment-related TEAEs were of mild or moderate severity

No deaths occurred during the study

References:
1. ZUBSOLV [prescribing information]. Orexo US, Inc.; 2016.
2. Bunavail [prescribing information]. BioDelivery Sciences International, Inc.; 2015.
3. Suboxone [prescribing information]. Indivior Inc.; 2016.

Indication

ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).

IMPORTANT SAFETY INFORMATION

Contraindications

  • ZUBSOLV sublingual tablet should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

Warnings and Precautions

  • ZUBSOLV sublingual tablet can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.

  • ZUBSOLV sublingual tablet can cause serious, life-threatening, respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (e.g., sedatives, tranquilizers, or alcohol). Patients should be warned against self-administration or misuse of these combinations.

  • ZUBSOLV sublingual tablet is not recommended in patients with severe hepatic impairment.

  • Not recommended for initiation of treatment (induction) in patients with moderate hepatic impairment due to the increased risk of precipitated withdrawal. Buprenorphine/naloxone products may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone. However, patients should be carefully monitored and consideration given to the possibility of naloxone interfering with buprenorphine’s efficacy.

  • Dose reduction of CNS depressants, ZUBSOLV sublingual tablet, or both should be considered in situations of concomitant prescriptions, as patients may exhibit increased CNS depression.

  • Store ZUBSOLV safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal respiratory depression in children.

  • Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit.

  • Intravenous misuse or taking ZUBSOLV sublingual tablet before the effects of full-agonist opioids (e.g., heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is likely to cause opioid withdrawal syndrome.

  • Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.

  • ZUBSOLV sublingual tablet is not appropriate as an analgesic. There have been reported deaths of opioid-naïve individuals who received a 2-mg sublingual dose of buprenorphine.

Use in Specific Populations

  • Pregnancy: Based on animal data, buprenorphine may cause fetal harm. Use of ZUBSOLV sublingual tablet in pregnant women or during breastfeeding should only be considered if the potential benefit justifies the potential risk.

  • Nursing mothers: Advise breastfeeding women taking buprenorphine products to monitor the infant for increased drowsiness and breathing difficulties.

  • Not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

Adverse Reactions

  • Adverse events commonly observed with the sublingual administration of buprenorphine/naloxone sublingual tablets during clinical trials and post-marketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

  • Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

  • Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

  • Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.

This is not a complete list of potential adverse events associated with buprenorphine/naloxone sublingual tablets. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking ZUBSOLV sublingual tablet, please call 1-888-ZUBSOLV (1-888-982-7658). You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information and Medication Guide.