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    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...
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    FDA Finalizes Buprenorphine Drug Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing new types of buprenorphine depot products for medication assisted treatment (MAT) for opioid use disorder amid the ongoing opioid epidemic.   Buprenorphine, along with methodone and naltrexone, are the only drugs approved by FDA to treat opioid use disorder.   Buprenorphine MAT works by reducing patients’ withdrawal symptoms and blocking the euphoric effects of other opioid drug...
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    FDA Approves First Buprenorphine Implant for Opioid Addiction

    The US Food and Drug Administration (FDA) on Thursday approved Braeburn Pharmaceutical's buprenorphine implant, Probuphine, to treat opioid dependence. The implant works by providing patients with a low dose of buprenorphine for six months as part of medication assisted treatment (MAT) for opioid dependence. In January, an FDA advisory committee narrowly backed the approval of the implant in a 12-5 vote. While supporters said Probuphine has advantages over pills because...
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    Obama Expands Buprenorphine, Naloxone Use to Fight Opioid Epidemic

    President Barack Obama on Tuesday introduced new measures to expand access to drugs used to treat opioid addiction. Specifically, states will see increased access to two opioid addiction drugs, buprenorphine and naloxone, and Obama announced the launch of a new interagency task force to ensure treatment parity for patients seeking help. In recent years, a growing number of Americans have become addicted to opioids and heroin. According to the Centers for Disease Control...