Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl

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In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a “danger” to public health. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids.

The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator. These “unique features” make the medicine well-suited for the military and therefore was a priority for the Pentagon, a point that factored heavily into the decision, according to FDA Commissioner Scott Gottlieb.

Although an FDA advisory committee last month recommended approval, the agency was urged by critics not to endorse the drug because it is 10 times more powerful than fentanyl, a highly addictive opioid. Among those who those who opposed approval were four U.S. senators and the FDA advisory panel chair, who could not attend the meeting, but took the rare step of later writing a letter to the agency.

The objections included complaints that Dsuvia has no unique medical benefits and might be easily diverted by medical personnel, despite a risk mitigation plan the manufacturer, AcelRx Pharmaceuticals, must maintain. There was also criticism the FDA failed to convene the Drug Safety and Risk Management Advisory Committee, not just the Anesthetic and Analgesic Drug Products Advisory Committee. Last year, the FDA refused to approve the medicine over concerns about usage directions and a need for additional safety data.

Came across this and thought i'd share it here. I really dislike opiates and their derivatives. They're highly addictive and turn you into a nodding zombie. I know too many people who've gotten addicted to different ones.

Fentanyl has been a fairly big problem here over the last few years a lot of people have overdosed and died. Even a few friends of friends and such. As far as i've read the number of deaths have finally started to decline since it first started getting bad. I worry this will just lead to yet another round of addictions, overdoses and deaths. Especially with such a convenient dosing method.

I guess for everyone be careful and if you have kids and such keep an eye out for this new worry soon.

a reply to: dug88

Sufentanil (Dsuvia) is 500 times more powerful than morphine. It sounds scary to my non-medically trained ears. Hopefully it will not become available on the black market because people who don't know it is 500 times stronger will die.

a reply to: dug88

The part that I find most interesting is that the Pentagon wanted it to be expedited. Why exactly would the military want such a powerful drug be produced ? Its a powerful painkiller, that in itself could be its own conspiracy.

originally posted by: LightSpeedDriver
a reply to: dug88

Sufentanil (Dsuvia) is 500 times more powerful than morphine. It sounds scary to my non-medically trained ears. Hopefully it will not become available on the black market because people who don't know it is 500 times stronger will die.

Fr

Currently sufentanil is the strongest opioid painkiller available for use in humans. Although stronger narcotic pain medications do exist, all medications stronger than sufentanil are approved for veterinary use only.

One step below animal drugs.

I remember looking up sufentinil a while ago when I was looking up fentinyl I didn't realize dsuvia was the same...all those synthetic opiates are scary...there really doesn't seem to be a need for something so strong.

all political parties are bought and paid by the Pharmaceutical industry, and continue to silence traditional indigenous plant/herb based medicines and treatments because it will destroy their empire

a reply to: LightSpeedDriver

I'm not saying its fair that people die from overdoses using these drugs. The question that comes to my mind though is how much assumed risk is on the individual in terms of choosing to do it or not.

From my understanding, all it takes is one dose and your out possibly for good. I've also got a good understanding of how addiction works, but still in my mind I dont fully understand. Myself, I have never used opioid of any kind because of the long term effects.

Have I sat in my house my whole life being a prude ? No I haven't, I've done more than my share and thank God my only addictions I have are minor compared to the burden others have.

a reply to: threeeyesopen

Only thing I can think of is field medic usage, if I was mortally wounded I'd want something rather strong to subside the pain without having a fellow soldier put a bullet in me to end my misery. That's just a thought, I am probably wrong. Never used an opiate so I'm pretty dumb about it all but I do know people who partake and it's sad really.. it's all they want or they are in the worse moods ever.

a reply to: MarlbBlack

That has been my initial thought as well, for medics and such but then why the rush ? Catch my drift ?

I knew a guy, although not very well, but I lived with him and he was addicted to the stuff. I saw him go up and down, overdoses, it was terrible and I thought what a terrible existence to have. Not to be mean but that's not living life, it's being dead.

If I was shot up and left dying, then this sounds like the kind of field pain relief you would be screaming for.

a reply to: Cobaltic1978

I dont doubt its effectiveness and I dont doubt I'd be screaming for something too. I just question the rush on getting it in use thats all.

Some people need heavy drugs to live without being in constant, agonizing pain.
I don't see the problem.

having a drug this strong, which can be lethal to human in the micro-gram dosage range, available as a sublingual tablet is VERY dangerous. I hope that this does not make it to the general public, and stays in military specialized usage.......diversion is a huge problem with health care professionals in general these days, so it will make it out on the black market.....it always does.

a reply to: dug88

Yet we continue to place our trust in government to run our lives...

a reply to: dug88

Maybe if the military has this drug we won't need to guard the opium crop against the Taliban in Afghanistan anymore.

Why else are we over there anyway? To keep out the Chinese? c'mon. This whole opiate epidemic began when we went over there. Just like the smuggling from the golden triangle during Vietnam. CIA claims they only sell to Russia and Kazakhstan.

Thanks for calling myself and others nodding zombies. Opiates have a very important role in treatment of pain, the constant belittling and looks of disgust and distrust by pharmacy techs and online comments about addicts get very, very old. I've been on them for almost 11 years now and not by choice. It's the only thing that gives me any semblance of life. Thanks to the current hysteria the rules regarding medical use have become so insanely ridiculous that people are now having to suffer needlessly by inadequate dosing and denial of treatment.

Yay, another drug that nobody can prescribe anyway. The military does fine with morphine. It's very effective and has a long track record to prove it. I fail to see why these pharma companies bother trying to formulate new pain medications. Must have been an accident.

a reply to: toms54

The CIA imported coc aine to the USA for years and probably still do out of public view. What's a few opioids (synthetic or otherwise) between citizens?

The war on drugs is a joke. If anything, things have only gotten worse.

To the poster above me, yes opiates are needed and definitely have their place. In a clinical setting. But, let's be honest, this will end up getting to the streets eventually. Then it's time for body bags. Addicts can't help themselves when something new comes along.

500 times more powerful than heroine, good grief.

Oh, it will be on the black market no doubt about it if its that powerful


Not that I want to bring conspiracy into this, but damn, maybe they want to add to the deaths

originally posted by: threeeyesopen
a reply to: Cobaltic1978

I dont doubt its effectiveness and I dont doubt I'd be screaming for something too. I just question the rush on getting it in use thats all.

You don't have to really think about it.

Either it is being bought and made public in order to get the population talking, or it's going to be required very soon.

originally posted by: toms54
a reply to: dug88

Maybe if the military has this drug we won't need to guard the opium crop against the Taliban in Afghanistan anymore.

Why else are we over there anyway? To keep out the Chinese? c'mon. This whole opiate epidemic began when we went over there. Just like the smuggling from the golden triangle during Vietnam. CIA claims they only sell to Russia and Kazakhstan.

Except where would the poppies come from needed to synthesize all the synthetic opiates? Oxycotin and percocets are still made from poppies at least. Though I think the poppies they use for Oxys come from Australia. They have special ones that only produce thebaine and not morphine or codeine.

Opium Poppies produce morphine, thebaine, codeine, papaverine, noscapine and oripavine among others naturally. These are where the opiate derivatives come from.

This is unbelievably potent stuff. 1-2 micrograms per kg lean body weight (or about 72 micrograms maximum for a 160-lb, slightly overweight guy like myself) is considered a starter dose:

Sufenta

Most medications are measured in milligrams. For comparison sake, Lysergic acid diethylamide (Elesse Dee), one of the most potent psychoactive substances known (and moreover, a relatively non-toxic one, with no known overdose) also has an effective low dose of about 75mcg.

Dsuvia/Sufentanil has the potential to kill many. Especially once the Mexican cartels learn how to bootleg it! It's only a matter of time.