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BUNAVAIL™
(buprenorphine and naloxone) buccal film

About Opioid Dependence:

Opioid dependence is a significantly undertreated condition in the U.S., with nearly 2 million people dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services.


Rates of prescription painkiller sales, deaths and substance abuse treatment admissions (1999-2010)

 

Rates of prescription painkiller sales, deaths and substance abuse treatment admissions<br />(1999-2010)

 

Opioid dependence is a medical diagnosis that is characterized by the inability of an individual to stop using opioids, both prescription opioids such as morphine, hydrocodone and oxycodone, as well as illicit opioids such as heroin, even when it is in the best interest of the individual to do so. Opioid dependence is a complex medical condition that often requires long-term treatment and care. The treatment of opioid dependence is important to reduce both the associated health and social consequences and to improve the well-being and social functioning of people affected.

 

About BUNAVAILTM (buprenorphine and nalaxone) buccal film (CIII)

On June 6, 2014, BioDelivery Sciences received approval of the New Drug Application (NDA) for BUNAVAILTM (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA). BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014.

BUNAVAIL is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration. BUNAVAIL was designed using BDSI's advanced drug delivery technology, BioErodible MucoAdhesive (BEMA®), allowing for the efficient and convenient delivery of buprenorphine while potentially overcoming some of the administration challenges presented by the sublingual (under the tongue) dosage forms currently available. BUNAVAIL has twice the bioavailability (drug absorbed into the body) of buprenorphine compared to Suboxone, the market leader in this category. As a result of the improved absorption of buprenorphine with BUNAVAIL, which is the direct result of the BEMA technology, plasma concentrations of buprenorphine comparable to Suboxone can be achieved with half the dose, which may help to reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects.

 

BUNAVAIL is the first mucoadhesive buccal film formulation of buprenorphine to compete directly with Suboxone sublingual film. In 2013, sales of Suboxone sublingual film increased to more than $1.3 billion in the U.S. while the total market grew to more than $1.7 billion, driven by a 14 percent increase in prescriptions according to data from Symphony Health Solutions.

 

INDICATION

BUNAVAILTM (buprenorphine and naloxone) Buccal Film (CIII) is a prescription medicine indicated for the maintenance treatment of opioid dependence.  BUNAVAIL should be used as part of a complete treatment plan to include counseling and psychosocial support.

 

Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).

 

IMPORTANT SAFETY INFORMATION

Keep BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) out of the sight and reach of children.  Ingestion of BUNAVAIL by a child may cause severe breathing problems and death.  If a child takes BUNAVAIL, get emergency help right away.

 

Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone, as serious negative effects including anaphylactic shock, have been reported.

 

Do not take BUNAVAIL before the effects of other opioids (e.g., heroin, methadone, oxycodone, morphine) have lessened as you may experience withdrawal symptoms.

 

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how BUNAVAIL affects you.

 

BUNAVAIL contains buprenorphine, an opioid that can cause physical dependence.  Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking BUNAVAIL without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

 

Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of BUNAVAIL is not the same as the amount of buprenorphine in other medicines.  Your doctor will prescribe a dose of BUNAVAIL that may be different than other buprenorphine-containing medicines you may have been taking.

 

BUNAVAIL can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines, sedatives, tranquilizers or alcohol.   You should not drink alcohol while taking BUNAVAIL, as this can lead to loss of consciousness or even death. 

 

Like other opioids (e.g., heroin, methadone, oxycodone, morphine), BUNAVAIL may produce orthostatic hypotension ('dizzy spells') in ambulatory individuals.

 

Common side effects of BUNAVAIL include headache, drug withdrawal syndrome, lethargy (lack of energy), sweating, constipation, decrease in sleep (insomnia), fatigue and sleepiness.

 

Because BUNAVAIL contains naloxone, injecting BUNAVAIL may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

 

BUNAVAIL can be abused in a manner similar to other opioids, legal or illicit.  Keep BUNAVAIL in a safe place. Do not give your BUNAVAIL to other people, it can cause them harm or even death. Selling or giving away this medicine is against the law.

BUNAVAIL is not recommended in patients with severe hepatic impairment.  BUNAVAIL may be used with caution for maintenance treatment in patients with moderate hepatic impairment.

 

Before taking BUNAVAIL, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking BUNAVAIL, tell your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth.

 

Before taking BUNAVAIL, talk to your doctor if you are breast-feeding or plan to breast-feed your baby. BUNAVAIL can pass into your breast milk and may harm your baby.  Monitor your baby for increased sleepiness and breathing problems.  Your doctor should tell you about the best way to feed your baby if you are taking BUNAVAIL.

 

This is not a complete list of potential adverse events associated with BUNAVAIL Buccal Film. Please see full Prescribing Information for a complete list.

 

To report negative side effects associated with taking BUNAVAIL Buccal Film, please call 1-800-469-0261. 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.

 

For more information, please see full Prescribing Information and Medication Guide for BUNAVAILTM Buccal Film (CIII).

 

 

 

Suboxone® is a registered trademark of Reckitt Benckiser Healthcare Ltd.

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