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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]. Morristown, NJ: Orexo US, Inc.; 2018.
2. Bunavail [prescribing information]. Raleigh, NC: BioDelivery Sciences International, Inc.; 2018.
3. Suboxone [prescribing information]. North Chesterfield, VA: Indivior Inc.; 2018.

Indication

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

Treatment should be initiated under the direction of healthcare providers who meet certain qualifying requirements under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).

IMPORTANT SAFETY INFORMATION

Contraindications

  • ZUBSOLV is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

Warnings and Precautions

  • Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.

  • Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with ZUBSOLV.

  • Unintentional Pediatric Exposure: 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): Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.

  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patients off of the opioid.

  • Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.

  • Risk of Hepatitis; Hepatic Events: Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.

  • Precipitation of Opioid Withdrawal Signs and Symptoms: An opioid withdrawal syndrome is likely to occur with parenteral misuse of ZUBSOLV by individuals physically dependent on full opioid agonists or by sublingual administration before the agonist effects of other opioids have subsided.

  • Risk of Overdose in Opioid-Naïve Patients: ZUBSOLV 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

  • Lactation: Buprenorphine passes into mother’s milk.

  • Geriatric Patients: Monitor for sedation and respiratory depression.

  • Moderate and Severe Hepatic Impairment: Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

Adverse Reactions & Drug Interactions

  • Adverse events commonly observed with the sublingual administration of ZUBSOLV are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

  • Benzodiazepines: Use caution in prescribing ZUBSOLV for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration/misuse.

  • CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing.

  • Antiretrovirals: Patients who are on chronic buprenorphine treatment should have their dose monitored if NNRTIs are added to their treatment regimen. Monitor patients taking buprenorphine and atazanavir with and without ritonavir, and reduce dose of buprenorphine if warranted.

  • Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue ZUBSOLV if serotonin syndrome is suspected.

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.