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Dr. Nabarun Dasgupta Profile picture
@nabarund
May 22 • 21 tweets • 10 min read Twitter logo Read on Twitter
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…
Nalmefene (Selincro) 18mg tablets are used in Europe to reduce heavy alcohol drinking, with EU-wide approval in 2013. But it is not approved in EU for reversing opioid overdose.
ema.europa.eu/en/medicines/h… ImageImage
In 2022, Purdue Pharma began selling it as an in-hospital drug for overdose reversal. Interestingly, "postoperative administration at the recommended doses did not prevent the analgesic response to subsequently administered opioids."
dailymed.nlm.nih.gov/dailymed/drugI…
Purdue's nalmefene has 2 dosing regimens -- in opioid-dependent patients you are supposed to do a tester shot to see if there isn't withdrawal in 2mins. The new nasal spray seems to do away with this.
nalmefenehcl.com/dosing-adminis… Image
As hedge against generic competition, the developers of Narcan Nasal swapped out naloxone for nalmefene in the sprayer. Got millions in gov't funding @BARDA. Then, they cashed out to Indivior (Suboxone maker) for $145M in Nov 2022.
indivior.com/en/media/press…
fiercepharma.com/drug-delivery/…
In FAERS data, nalmefene was ALWAYS administer *after* naloxone. It was a second line drug. Big Question: Why did these patients get nalmefene? Poor response to naloxone? Novelty? Other reason? No FDA Ad Com so we don't have answers.
fis.fda.gov/sense/app/9523… ImageImage
Do we really need another opioid antagonist? Let's look at the science. Start here with @HillPharmD @TheSUDPharmD @clairezagorski

ncbi.nlm.nih.gov/pmc/articles/P…
The purported need arises because fentanyl is sequestered in body fat, and can leech out after naloxone wears off. I get the pharmacology, but is this an issue in IRL?
Bell & Bennett report no change in number of naloxone doses during fentanyl era in Pittsburgh
journals.sagepub.com/doi/abs/10.108…
Anesthesiologists use naloxone to reverse fentanyl every day. These skilled doctors aren't buying into fentanyl hysteria, nor demanding pharma to "innovate" #nalmefene nasal spray for kids. @LeoBeletsky @ZachWritesStuff @RyanMarino @clarkfreifeld et al.
ncbi.nlm.nih.gov/pmc/articles/P…
Over 210,934 overdose reversals by EMS thru April 30, 2023, the average number of naloxone doses was 1.0 (yeah, one point zero). So EMS aren't the ones demanding nalmefene.
nemsis.org/opioid-overdos… Image
Marketing strategy for $IDVVY #nalmefene:
Use the school-to-prison pipeline

Last month CEO promised investors a QUARTER BILLION DOLLARS in sales in 1st yr. How? Sell to schools. cops. prisons.

Not harm reduction who have most reach. Not medical providers. Not insurance.
Market forces would suggest that nalmefene nasal spray will be AT LEAST as expensive as Narcan Nasal Spray, $50. With the hype, expect it to be higher. Meanwhile, a few million would cover the entire US with cheap generic naloxone.
I met Opiant's lobbyists. For months in advance of the sale, they have been lobbying (successfully) to change state standing orders to include "all opioid antagonists" instead of "naloxone"
Other pharma are lining up to make nalmefene implants and market it for "pathological gambling." Clearly there is more going on than a simple OD antidote.
prnewswire.com/news-releases/…
ajp.psychiatryonline.org/doi/abs/10.117…
Nalmefene nasal was developed in scientific secrecy. It is yesterday's response to a drug market that has moved on. It was *not* tested on fentanyl-xylazine. But there's evidence of activity in other brain receptors not involved in respiratory depression. nature.com/articles/13008… Image
Why are folks skeptical? Because it starts quicker, and lasts waaaaaaaaay longer and higher than naloxone. @HillPharmD dropped this at the nHRC conf last year. What is long withdrawal like in opioid-dependent patients? Image
For transparency, I'm an uncompensated Board member of @RemedyAllianceFTP that makes bulk low cost naloxone available for harm reduction programs. We will provide ANY form of opioid antagonist to our people if it has a proven record of safety in the community, and is affordable.
The new product is called #Opvee and granted to $OPNT, but now owned by $IDVY.

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More from @nabarund

Dr. Nabarun Dasgupta Profile picture
Apr 12
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
Dr. Nabarun Dasgupta Profile picture
Feb 15
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
Dr. Nabarun Dasgupta Profile picture
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
Dr. Nabarun Dasgupta Profile picture
Sep 21, 2022
“There are a lot of abandoned people who were on pain medications, who cannot get access to adequate pain management anymore, and are therefore, increasingly, turning to the street. We hear those stories every day.”

time.com/6214811/overdo…
Thanks to @ibdgirl76 @LelenaPeacock and others who have shared with me many stories about abandoned CPP. This article from @TaraLaw27 is a solid starting point to recentering folks in pain who can’t get the help they deserve.
To be clear, overdose deaths now mostly involve unregulated street drugs. Those who are dying are heterogenous: people who were on Rx opioids for years, people who never got a single script, suicides from lack of pain ctrl, and occasional users w/o tolerance.
Read 4 tweets
Dr. Nabarun Dasgupta Profile picture
Oct 1, 2021
To initiate over-the-counter status for prescription drugs, FDA prioritized *anti-flatulent drugs* and *ingrown toenails* over life-saving antidote naloxone. I daresay preventing 93,000 overdose deaths should have been first. 🧵 with Maya & @ejwheeler9
accessdata.fda.gov/scripts/cder/o…
@ejwheeler9 We have an incredible opportunity. A generic pharma is willing to make a harm reduction-only naloxone. They have filed for the new NDC. If we have an injectable naloxone that can only be accessed by syringe exchange programs, why do we need the antiquated Rx requirement?
@ejwheeler9 Would you pay $2 to save a life? With political will, we could have $2 OTC naloxone by Thanksgiving. There is a 45 day public comment period. This would be restricted to harm reduction programs, the ones that form the backbone of overdose prevention.

fda.gov/drugs/over-cou…
Read 15 tweets
Dr. Nabarun Dasgupta Profile picture
Sep 16, 2021
Finally attention to xylazine. But these reports miss the point because they aren’t actually talking to people who use drugs.

Xylazine in dope is intentional. PWUD like it because it holds of withdrawal. Yet it may cause fatal iron depletion.

cdc.gov/mmwr/volumes/7…
There appears to be some mu opioid agonism, or similar pathway that prevents withdrawal without causing an opioid high. (Tho usually mixed with fentanyl.
People in Greesboro tell us that it is cheaper b/c you can dose 2x/day instead of every 4h with fent. But it causes a deep 20-40 sedation, which most PWUD don’t like. @WeezieBeale
Read 11 tweets

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