Suboxone.com - Advances in Treatment

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IMPORTANT INFORMATION:

On December 8, 2006, Federal legislation was passed allowing physicians to treat up to 100 opioid-dependent patients with Suboxone at any given time—a significant increase from the previous limit of 30 patients.

There may be doctors in your area participating in a study to measure opioid dependence treatment outcomes. Patients who meet the eligibility requirements to participate in this study can receive up to $225 in compensation to complete surveys about their treatment.

NOTE: This study is only open to patients not currently under the care of a physician for opioid dependence and are seeking a treatment provider.

Please call 1-866-455-8876 between 9:00 AM to 7:30 PM EST to get more information.

Seeking Information for myself or loved one

Here to Help™ provides support throughout treatment. Whether you're seeking treatment information or you're already in treatment, we can provide resources that can help you make treatment a success.

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Prescribing Information -- Site Map

Now Approved - SUBOXONE(R) (buprenorphine and naloxone) Sublingual Film CIII - Learn more about SUBOXONE Film

Support That Helps Patients Stay In Treatment

Learn how patients can benefit from this free support system

Become a Here to Help Provider

Learn how becoming a provider can benefit you and your practice

Mechanism of Action (MOA)

Learn about how SUBOXONE addresses the biological basis of dependence

Get certified to prescribe SUBOXONE

Information on becoming certified to treat opioid dependence in your office with SUBOXONE

Advances in Treatment

Office-based treatment with SUBOXONE is regarded as an important advance in the treatment of opioid dependence for 4 primary reasons:

Enhanced treatment confidentiality
Enhanced treatment convenience
Treatment advantages of a partial opioid agonist
Limiting diversion and misuse

Enhanced Treatment Confidentiality
The strength of the stigma attached to opioid dependence and treatment is hard to dispute.

Every year in the United States, thousands of patients decide that the benefits of being treated for opioid dependence are outweighed by the risk of that treatment being exposed—and the patient's being irreversibly stigmatized as a result.^1,2

Edwin A. Salsitz, MD, director of the methadone program at Beth Israel Medical Center in New York was quoted in The New York Times as saying "the most stigmatized thing in this world is [opioid dependence treatment]..." adding that "there is nothing people try to hide more..."³

Under these circumstances, the enhanced confidentiality afforded by office-based treatment should have significant appeal to a number of opioid-dependent patients.

For many, the draw of office-based treatment is as simple as there being nothing about the visit that might cause a SUBOXONE patient to stand out from anyone else.

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Enhanced Treatment Convenience
SUBOXONE's status as a prescription medication that can be dispensed for take-home use offers patients a freedom and convenience unique among opioid-dependence treatments, specifically:

SUBOXONE patients are not tied to daily clinic visits
Patients are free to go on business trips, to visit family and friends out of state, and to go on vacation
SUBOXONE does not require patients to be admitted to a residential healthcare facility
Patients do not need to take extended time off from work or otherwise call attention to their treatment

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Treatment Advantages of a Partial Opioid Agonist
Buprenorphine, the primary active compound in SUBOXONE, is a partial opioid agonist at the mu-opioid receptor.

The treatment advantages of buprenorphine stem from 3 features: a high affinity for the mu receptor, slow dissociation from that receptor, and a relatively low intrinsic activity. These properties enable buprenorphine to:

Control patients' opioid withdrawal symptoms and opioid cravings
Cause limited euphoria compared with full agonists, but still produce sufficient positive effects to aid in treatment compliance^4,5
Cause less physical dependence than full agonists⁵
Less physical dependence and euphoria mean buprenorphine carries a lower potential for abuse than full agonists⁵
Block the effects of subsequently administered opioids by preventing them from binding to the mu receptors⁵
The appeal of using supplemental opioids is undermined by their diminished ability to produce a euphoric effect in the patient¹
Provide a wider margin of error with respect to dosing time and regularity
Slow dissociation from the mu receptor allows the therapeutic effect of SUBOXONE to last for up to 2 to 3 days, depending on dose
Pose less risk for fatal respiratory depression compared with full agonists because of the "ceiling effect" characteristic of partial opioid agonists^5,6
As with all opioid agonists, there is a risk of respiratory depression; patients should be warned of the potential danger of not using SUBOXONE according to the product information labeling and physician instructions

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Limiting Diversion and Misuse
SUBOXONE also includes a naloxone component to discourage diversion and abuse. Generally, naloxone has no clinically significant effect when taken sublingually. If SUBOXONE is crushed and injected, the naloxone is included to attenuate the effects of buprenorphine and to precipitate withdrawal in an individual dependent on a full opioid agonist.

Please see WARNINGS and PRECAUTIONS sections of full SUBOXONE Prescribing Information for additional safety data.

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References

1.	Center for Substance Abuse Treatment (CSAT). Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration, 2004.
2.	Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2003 national survey on drug use and health: national findings. Rockville, Md: Department of Health and Human Services, SAMHSA, Office of Applied Studies; 2004. NSDUH Series H–25, DHHS Publication No. SMA 04-3964.
3.	O'Connor A. New ways to loosen addiction's grip. The New York Times. August 3, 2004;sect F:1.
4.	Mattick RP, Ali R, White JM, O'Brien S, Wolk S, Danz C. Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients. Addiction. 2003;98:441-452.
5.	Walsh SL, Eissenberg T. The clinical pharmacology of buprenorphine: extrapolating from the laboratory to the clinic. Drug Alcohol Depend. 2003;70(suppl 2):S13-S27.
6.	Walsh SL, Preston KL, Stitzer ML, Cone EJ, Bigelow GE. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994;55:569-580.

Important Safety Information

SUBOXONE^® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone.

SUBOXONE Sublingual Film 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.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.

SUBOXONE Sublingual Film 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 (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported. Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.

Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

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

To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

SUBOXONE^® (buprenorphine HCl/naloxone HCl dihydrate) sublingual tablets (CIII) is indicated for the treatment of opioid dependence.

It is extremely dangerous to self-administer non-prescribed benzodiazepines or other depressants while taking SUBOXONE. A serious overdose and death may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as SUBOXONE.

SUBOXONE has potential for abuse and produces dependence of the opioid type, with a milder withdrawal syndrome than full agonists.

Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine.

Allergic reactions including bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients taking buprenorphine.

There are no adequate and well-controlled studies of SUBOXONE (a Category C medication) in pregnancy.

Caution should be exercised when driving cars or operating machinery.

Always store buprenorphine-containing medications safely and out of the reach and sight of children. Destroy any unused medication appropriately.

The most commonly reported adverse events with SUBOXONE include: headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and sweating (14%, placebo 10%). Please see full Prescribing Information for a complete list.

To report an adverse event caused by taking SUBOXONE, please call 1-877-782-6966. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For information about SUBOXONE Film, please see full US Product Information for SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII)

For more about SUBOXONE Tablets, please see full US Product Information for SUBOXONE (buprenorphine and naloxone) sublingual tablets (CIII)

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