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
- Data on file. Orexo US, Inc.
What is ZUBSOLV®?
ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is a prescription medicine used to treat adults who are addicted to opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
IMPORTANT SAFETY INFORMATION
Do not take ZUBSOLV if you are allergic to buprenorphine or naloxone as serious negative side effects, including anaphylactic shock, have been reported.
ZUBSOLV can cause serious and life-threatening breathing problems. Call your healthcare provider right away or get emergency help if (a) you feel faint, dizzy, or confused; (b) your breathing gets much slower than is normal for you; (c) you feel sleepy and uncoordinated; (d) you have blurred vision; (e) you have slurred speech; (f) you cannot think well or clearly; or (g) you have slowed reflexes and breathing. In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with ZUBSOLV.
ZUBSOLV contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about the difference between physical dependence and addiction. Do not stop taking ZUBSOLV without talking to your healthcare provider. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
Your healthcare provider may monitor liver function before and during treatment with ZUBSOLV.
Keep ZUBSOLV in a secure place away from children. If a child accidentally takes ZUBSOLV, this is a medical emergency and can result in death. Get emergency help right away.
The most common side effects of ZUBSOLV include: headache, drug withdrawal syndrome, nausea, decrease in sleep (insomnia), vomiting, pain, increased sweating, swelling of the extremities, and constipation. Tell your healthcare provider about any side effect that bothers you or that does not go away.
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 the amount of buprenorphine in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of buprenorphine that may be different than other buprenorphine-containing medicines you may have been taking.
ZUBSOLV is not for occasional or “as needed” use. An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using ZUBSOLV. Ask your healthcare provider what you should do if you are taking one of these. You should not drink alcohol while taking ZUBSOLV, as this can lead to loss of consciousness or even death.
Do not inject (“shoot-up”) ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections and other serious health problems. Injecting ZUBSOLV may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
Before taking ZUBSOLV, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before taking ZUBSOLV, tell your healthcare provider if you are pregnant or plan to become pregnant. If you take ZUBSOLV while pregnant, your baby may have signs of withdrawal at birth and that withdrawal is treatable. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
Before taking ZUBSOLV, tell your healthcare provider if you are breastfeeding or plan to breastfeed. ZUBSOLV can pass into your breast milk and may 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 sleepiness and breathing problems.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how ZUBSOLV affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take ZUBSOLV.
ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.
Store ZUBSOLV securely, out of sight and reach of children, and in a location not accessible by others, including visitors at home.
This is not a complete list of negative side effects associated with ZUBSOLV. For a complete list please see full Prescribing Information.
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.