Dr. Nabarun Dasgupta Profile picture
Sep 11, 2020 9 tweets 5 min read Read on X
It's been 10 years since #OxyContin was re-engineered to make it hard to crush. But #publichealth benefits are still unclear. Here is a brief video of the epidemiology challenges.

vimeo.com/456967594

As guest speaker at FDA Advisory Committee

#RxEpi
#pharmacoepidemiology Image
A *product-centric* worldview, holds that abuse deterrence is primarily the property of the drug, and that that is the PRIMARY thing that changed with the reformulation, especially in the immediate aftermath.
A *person-centric* view holds that abuse deterrence is not merely a property of the drug, but rather an interaction between engineering and society, between physiochemical properties and point-of-prescribing medical decisions.
We must consider if abuse deterrence is inherent property of the drug itself, or if its intended effect lies in an interaction w/social context. If we accept it is more than a biochemical property, label language becomes more challenging, albeit w/potential to be more accurate.
Quote above from my comment on the Australian studies of OxyContin
thelancet.com/journals/lanps…
You can watch the conclusion of the Ad Com this afternoon
collaboration.fda.gov/dsarmaadpacsep…

Slides and 1000+ pages of scientific review from FDA and Purdue are here:
fda.gov/advisory-commi…
Props to our illustrator @brittainpeck
Interactive map on ADF prescribing here by @chris_delcher @_GYOh_ @yanningwang & others at @UK_COP

pharmacy.uky.edu/research-0/res…

Full paper here pubmed.ncbi.nlm.nih.gov/32686223/ Image
Apologies for leaving @JohnRxBrown off the credits list! Didn’t realize you were on Tw. John conducted the analyses and surveys I presented along with Trish Freeman @UK_COP.

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More from @nabarund

Jun 7
Let's bring some science into all this talk about #medetomidine. 🧵

TLDR: Expect unexpected sedation.

We predicted it would soon emerge in illicit supply, and @US_FDA agreed, and so we have this grant to investigate its pharmacology, etc. @nanopharmNC

fda.gov/science-resear…
We first observed #medetomidine in NC in a sample collected in October 2022, in Raleigh. Combined with xylazine, and traces of fentanyl and meth. @LunaJBear
streetsafe.supply/results/p/3004…
If you've seen me present in the last year, #medetomidine has been sitting on our team's Watch List (slide 52) for awhile now.
cdr.lib.unc.edu/concern/schola…
Read 24 tweets
Sep 9, 2023
1 🚨Attention please: Turns out #xylazine is a kappa opioid. This validates experience from frontline folks and PWUD. Fresh science from collaborators @nanopharmNC @MadiganLBedard @zenbrainest
Pre-print:
Public health 🧵 below
#TwitteRx #harmreductionbiorxiv.org/content/10.110…
Check out @nanopharmNC's explainer on the lab science. I'll breakdown the #publichealth implications.
@nanopharmNC Basic pharmacology. Mu is the opioid receptor in the brain we usually talk about when we say “opioid” – but there are others. Kappa is less popular, but still very much an opioid receptor. HOWEVER, it’s NOT canonically linked to opioid euphoria.

sites.tufts.edu/opioidpeptides…
Image
Read 18 tweets
May 22, 2023
Let's talk #nalmefene for OD reversal, an old generic drug in new expensive clothes. FDA approved Rx-only nasal spray today. Will this help prevent overdose deaths in the fentanyl-xylazine-strongbenzo era?

🧵👇

fda.gov/news-events/pr…
Nalmefene was developed in the 1980s by erstwhile Key Pharma in Miami, with help from scientists at @UVA
europepmc.org/article/med/39…
It was marketed as an injectable by Baxter Pharma as Revex for alcohol dependence, initially approved in April 1995 and "discontinued on May 21, 2008, for business reasons."

federalregister.gov/documents/2017…
Read 21 tweets
Apr 12, 2023
Based on our lab data, I reckon #xylazine shows up in the drug supply 5 specific ways:
🧵👇
1. Veterinary diversion is rare, niche, and localized to interconnected Caribbean communities:

Philly


Puerto Rico
link.springer.com/article/10.118…
2. Most commonly... Fentanyl and #xylazine in combo, about 3:1.

We don't see xylazine-related synthesis impurities but do see fentanyl impurities, so our hypothesis is that xyl is being added intentionally in pure form.
Example from Lexington NC: streetsafe.supply/results/p/3003…
Read 14 tweets
Feb 15, 2023
Y'all ready for this? 🍿👊
#NarcanAdCom about to pop off
Use this # to follow today's updates

CONCEPT
The culmination of 2 decades of advocacy to make naloxone OTC

REALITY
2 decades of advocacy erased by overdose crisis profiteers $EBS

Right out the gate, FDA frames this as a solution for saving kids from overdose. Guess that’s why there are so many pediatric anesthesiologists on the AdCom
In the review of the history FDA forgets to credit the people (like Dan Bigg) who invented the intervention
Read 53 tweets
Sep 23, 2022
🚨 Something huge happened today. 🚨

@US_FDA @DrCaliff_FDA listened to harm reduction programs and made it infinitely easier to purchase #naloxone in bulk. With 100,000+ overdose deaths each year, we need BIG solutions.

w/@RemedyAlliance @ejwheeler9 @coreysdavis
🧵 1/26
@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis The FDA Guidance provides clear federal support for bulk purchase and distribution of naloxone to meet one of the biggest public health challenges of our times.

Full text via link below, but let's break it down.


2/26
@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis This is a watershed moment. Along with low-cost naloxone available through @RemedyAlliance and state standing orders, this Guidance establishes a trifecta of innovations that will help rapidly scale up naloxone distribution.
3/26
Read 33 tweets

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