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PDUFA for PROBUPHINE for the indication of maintenance treatment of opioid dependence

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INDV.L

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Braeburn Pharmaceuticals

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BDSI

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Additional Information

Management Comment According to recent estimates, there are 2.2 million people with opioid dependence in the U.S. Approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Before the year 2000, medication-assisted therapies for opioid dependence were available in the U.S. only from a limited number of approved facilities. The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed medical office-based treatment of opioid dependence and greatly expanded patient access to medication-assisted treatment. Sales of buprenorphine drug products for the treatment of opioid addiction in 2014 were approximately $1.75 billion in the United States.
https://braeburnphar...
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Related Keywords Buprenorphine Hydrochloride, Ethylene Vinyl Acetate, Probuphine