My Testimony Before the ADCOM for AcelRex’s DSUVIA

ADCOM

On Friday, Oct. 12, 2018, AcelRex Pharmaceuticals, Inc. presented its case to the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (ADCOM) to discuss the approval of the new drug application (NDA) 209128 for DSUVIA™. DSUVIA is a small sufentanil pill deposited below the tongue with an applicator. It is…

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People in Pain Speak Out

Woman holding a megaphone - POTS

HHS Pain Task Force Holds Its Inaugural Meeting The U.S. Department of Health and Human Services (HHS) Pain Task Force held its inaugural meeting in May 2018 that included a public comment period. Members of the public had also been invited to submit their comments about chronic pain online, and the site received 2,530 posts.…

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Treating Babies with Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Means Babies Are Born in Withdrawal Babies who are exposed to drugs in the womb may be born with neonatal abstinence syndrome (NAS). Some people mistakenly believe these infants are born addicted to opioids. In fact, babies with NAS are born in withdrawal from opioids. They are not addicted to them. If…

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Response to People in Pain

Response to People in Pain

CDC Guidelines for Opioid Prescriptions  The CDC Guideline for Prescribing Opioids for Chronic Pain, published by the Centers for Disease Control and Prevention (CDC) in March 2016, was meant to provide recommendations for prescribing opioids. It was not meant to mandate policy. Since then, states have developed their own restrictive guidelines for prescribing opioids largely…

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Opioid Lawsuits Threaten Lives of Pain Sufferers

Opioid Lawsuits Threaten Lives of Pain Sufferers

Implications for People With Chronic Pain Several lawsuits have been filed against several opioid manufacturers, distributors, and physicians for participating in what was allegedly a scheme to cause incalculable harm for profit. I am one of the physicians named as an alleged “conspirator.” The opioid lawsuits are far more than legal matters that involve the…

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Repeating the Mistakes of the Past

Repeating the Mistakes of the Past

I’m pleased to present a blog written by Megan Nalamachu who is a bright, articulate high school student. Her father, Dr. Srinivas Nalamachu, is a treasured colleague and friend. He proudly sent me his daughter’s well-researched work, because he believed I’d be interested in it. He was correct. Megan did a wonderful job rendering a…

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Prescription Drug Advertisements

Prescription Drug Advertisements

  Selling Prescription Drugs via Direct-to-Consumer Advertising “Next year, how about fewer ads that fuel opioid addiction and more on access to treatment,” White House Chief of Staff Denis McDonough complained on Twitter. “Was that really an ad for junkies who can’t [poop]? America, I luv ya but I just can’t keep up,” TV host…

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Open Letter to Journalists and Editors About “Addicted Babies”

Open Letter to Journalists and Editors About “Addicted Babies”

Babies Cannot Be Born Addicted to Drugs “Babies Born Addicted,” “Addicted Babies,” “Babies with Addiction,” and similar headlines appear nearly daily in the media. This is because babies exhibit horrible withdrawal symptoms if they are born physically dependent on opioids, and it pulls at our heartstrings to see them suffer. But it misleads media consumers,…

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