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 Post subject: FDA Approves New Buprenorphine/Naloxone Formulation
PostPosted: Sun Aug 18, 2013 4:39 pm 
Zubsolv® is a product for the treatment of opioid dependence. In July 2013, Zubsolv was approved for the maintenance treatment of opioid dependence by the U.S. Food and Drug Administration, FDA.

Zubsolv® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the maintenance treatment of opioid dependence and should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).

Zubsolv sublingual tablet 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. Liver function should be monitored before and during treatment. Children who take Zubsolv sublingual tablet can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep Zubsolv sublingual tablet out of the sight and reach of children.

Adverse events commonly observed with the sublingual administration of buprenorphine/naloxone sublingual tablets during clinical trials and post-marketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema.

SOURCE: http://www.orexo.com/en/Products/Zubsolv_Treatment_of_opioid_dependence/


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 Post subject: Re: FDA Approves New Buprenorphine/Naloxone Formulation
PostPosted: Sun Aug 18, 2013 4:41 pm 
***Important note....
This is the first formulation of buprenorphine specifically approved/indicated for the *maintenance treatment* of opioid dependence. All previous formulations (Suboxone, Subutex & their generics) have been indicated for the short-term/detoxification treatment of opioid dependence. This is significant and will hopefully remedy some of the problems with insurance companies only wanting to pay for buprenorphine treatment for a limited number of months, etc. They have been pointing to the fact that Suboxone & Subutex are indicated for detoxification treatment. Now there will be a formulation of buprenorphine specifically indicated for the *maintenance treatment* of opioid dependence.


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