Man_Patient_Clinical_Data

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No increased rate of withdrawal symptoms or discontinuation after patients were changed from Suboxone® film to ZUBSOLV®

In the largest combination buprenorphine/naloxone opioid dependence trial (N=758) ever conducted in the United States, ZUBSOLV was proven to provide a comparable clinical effect to Suboxone film with the added benefit of patient-preferred attributes1

  • A randomized, noninferiority study to assess treatment efficacy of ZUBSOLV vs Suboxone film and to explore switching between treatments1
    • 758 patients with opioid dependence for a mean of 11 years
    • Stabilization doses were titrated to a maximal daily dose of 17.1 mg/4.2 mg for ZUBSOLV and 24 mg/6 mg for Suboxone film based upon clinical symptoms
  • ZUBSOLV showed comparable retention at Day 15 vs Suboxone film (74.9% vs 74.4%)
  • No difference in cravings (21.6 with ZUBSOLV vs 19.1 with Suboxone film; mean VAS score at Day 15)
  • Discontinuation rates
    • 8.7% of patients discontinued when changed from ZUBSOLV to Suboxone film
    • 6.1% of patients discontinued when changed from Suboxone film to ZUBSOLV

After patients were changed to ZUBSOLV, no statistically significant differences from Suboxone film were seen in:1



COWS=Clinical Opiate WIthdrawal Scale. COWS is measured on a scale of 0-48 where a lower score is favorable.
SOWS=Subjective Opiate Withdrawal Scale. SOWS is measured on a scale of 0-64 where a lower score is favorable.
VAS=Visual Analog Scale. VAS is measured on a scale of 0-100 where a lower score is favorable.

Adverse events were similar across treatments1

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



  • The percentages of patients with TEAEs were similar between the 2 treatments (post Day 3 through Day 15, 11.8% vs 10.8% for ZUBSOLV and Suboxone film, respectively)
    • Gastrointestinal effects were minimal with constipation reported in <5% of patients in both phases of 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 either phase of the study

Reference:

  1. Data on file. Orexo US, Inc.

What is ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII)?

ZUBSOLV is a prescription medicine used to treat opioid addiction in adults and is part of a complete treatment program that also includes counseling and behavioral therapy.

Important Safety Information

What is the most important information I should know about ZUBSOLV?

  • ZUBSOLV contains an opioid called buprenorphine that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs. Get emergency help right away if you feel faint, feel dizzy, are confused, feel sleepy or uncoordinated, have blurred vision, have slurred speech, are breathing slower than normal, cannot think well or clearly.

  • Talk to your healthcare provider about naloxone, which is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental use of ZUBSOLV by a child. If naloxone is given, you must still call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid. In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and being treated with ZUBSOLV.

  • Do not take ZUBSOLV with certain medicines. Taking ZUBSOLV with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

  • Do not inject (“shoot up”) ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections, other serious health problems, and sudden serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

  • Do not switch from ZUBSOLV to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of ZUBSOLV is not the same as other medicines that contain buprenorphine.

  • Do not stop taking ZUBSOLV suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine (physical dependence). Physical dependence is not the same as drug addiction.

  • Never give anyone else your ZUBSOLV. They could die from taking it. Selling or giving away ZUBSOLV is against the law. Store ZUBSOLV securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Who should not take ZUBSOLV?

  • Do not take ZUBSOLV if you are allergic to buprenorphine or naloxone.

What should I tell my healthcare provider before taking ZUBSOLV?

Before taking ZUBSOLV, tell your healthcare provider:

  • about all of your medical conditions and all of the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

  • if you are pregnant or plan to become pregnant. If you take ZUBSOLV while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life-threatening if not recognized and treated.

  • if you are breastfeeding. ZUBSOLV can pass into your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take ZUBSOLV. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with ZUBSOLV.

What are the possible side effects of ZUBSOLV?

ZUBSOLV can cause serious side effects, including:

  • Trouble breathing. Taking ZUBSOLV with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants can cause breathing problems that can lead to coma or death.

  • Sleepiness, dizziness, and problems with coordination.

  • Physical dependence or abuse.

  • Liver problems. Call your healthcare provider right away if you notice any of these symptoms: your skin or the white part of your eyes turns yellow (jaundice), dark or “tea-colored” urine, light colored stools (bowel movements), loss of appetite, pain, aching, or tenderness on the right side of your stomach area, nausea. Your healthcare provider should do blood tests to check the liver before you start and while you are taking ZUBSOLV.

  • Allergic reaction. Call your healthcare provider or get emergency help right away if you have a rash, hives, swelling of your face, wheezing, low blood pressure or loss of consciousness.

  • Opioid withdrawal. Call your healthcare provider right away if you get any of these symptoms: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting, muscle aches.

  • Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.

  • The most common side effects of ZUBSOLV include: headache, nausea, vomiting, constipation, pain, increased sweating, decrease in sleep (insomnia).

  • ZUBSOLV may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your healthcare provider.

To report negative side effects associated with taking ZUBSOLV, please call 1-888-982-7658. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.