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Two Novel Opioids
Win Tepid Backing From FDA Panel
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Two more opioids . . . . . . . . oh boy! more opioids
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The only class of pain drugs that rakes in $40,000 per month or more for a single patient. We’d see pharma thinking about something better than opioids if they were blocked from charging more than gabapentin. Opioids cost pennies yet these formulations can cost more than $1,000 a day and they are poorly effective for chronic pain.
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“Both committees — the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety Risk Management Advisory Committee (DSaRM) — were asked to consider a proposed indication of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.”
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“Many of the committee members said their “yes” votes on approval came with some hesitation — while Teva’s product may be an incremental step in the right direction, there needs to be better outcome measures for reductions in abuse resulting from reformulations, as well as improved outcomes for the treatment of pain, they said.
Meeting a second day, the same panel also voted 9-6 to “recommend” approval of a different abuse-deterrent product, this one combining extended release oxycodone with naltrexone (Troxyca). The slim margin is often seen a null recommendation.”
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Don’t get excited about naltrexone in these formulations. When injected into vein, it will block the effect of the opioid.
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Pain Management Specialist in San Diego & La Jolla 
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