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2 New Fentanyl Products On The Horizon

Tchort

Tchort

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Exhibit A

Fentanyl Mouth Patch Approved

07/17/2009

The Examiner

Cancer patients have a new option for dulling spikes in pain.

The U.S. Food and Drug Administration has approved the Onsolis oral patch for managing breakthrough pain. The agency defines breakthrough pain as "severe flares of pain ."

Onsolis is supplied as a patch that attaches to the inner cheek. Its use has only been studied in adults who have already taken narcotic medications to reduce pain.

To receive Onsolis, patients must register with the FOCUS--Full Ongoing Commitment to User Safety--program, which is aimed at preventing abuse and diversion of the patch.

Biodelivery Sciences International will market Onsolis, which is made by Aveva Drug Delivery Systems.
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http://www.examiner.com/x-15966-Nor...iner~y2009m7d17-Fentanyl-mouth-patch-approved

Exhibit B

Nycomed’s Intranasal Fentanyl Drug Gains European Approval for Breakthrough Cancer Pain

07/24/2009

Genengnews.com

The European Commission granted Nycomed marketing authorization for its cancer pain drug, Instanyl®. This intranasal fentanyl spray is indicated for managing breakthrough pain in adult patients who are already receiving maintenance opioid therapy for chronic pain. Nycomed plans to launch the product this year.

“Instanyl has a fast onset, a short duration, is well tolerated, and is easy to use, allowing the patients effective control of the pain episodes with minor adverse effects,” notes Stein Kaasa, M.D., Ph.D., from Trondheim University Hospital in Norway, who was involved in conducting clinical trials with Instanyl. Dr. Kaasa is also chairman of the Research Network of the European Association for Palliative Care.

Nycomed reports that this is the first intranasal fentanyl product sanctioned in Europe. In March Orexo’s obtained approval for its sublingual fentanyl treatment for breakthrough cancer pain, Abstral, from regulatory authorities in France and Spain. Abstral has also received a positive recommendation for approval by the EMEA. It is currently distributed in Sweden, the U.K., and Germany.

In the U.S., the FDA recently approved BioDelivery Sciences’ breakthrough cancer pain product, Onsolis. This is the first product to utilize the company’s bioerodible mucoadhesive drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa. Onsolis is expected to be available early in the fourth quarter.
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http://www.genengnews.com/news/bnitem.aspx?name=58834800
 
Great, two new ways for people to OD off fentanyl!! I hope these are rarely prescribed to those in extreme pain because when they hit the streets it can turn into disaster.
 
An intranasally administered pharmaceutical? I really would have thought that would have been shot down by the social stigma that snorting drugs makes them worse for you. Interesting, to say the least.
 
8-12 said:
An intranasally administered pharmaceutical? I really would have thought that would have been shot down by the social stigma that snorting drugs makes them worse for you. Interesting, to say the least.
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Stadol was used for years(and years and years) and it was a opiate nasal spray(that was the shizznit ;)).
 
Wait so this isn't a new analogue/form of Fentanyl right?

It's just a new ROA?


and wow...ya, I can see an OD very possible with snortable Fent lol wow...ya very easy to see
 
Why would an OD be more possible?

Fentanyl isn't a dangerous drug when it's accurately measured. The danger from fentanyl comes from the patch form or the fake heroin form. The patch gives you milligrams at a time in a gel of unknown density, and the fake heroin gives you inconsistently mixed powder with hot spots of fentanyl.

I'm going off the first statistic I saw, but the therapeutic index for fentanyl is 270 and for morphine it's only 70.

Being able to snort tiny, measured bursts of the drug with a nasal spray device is probably the SAFEST way to ingest it and it's probably safer than morphine according to the data.
 
Coolio said:
Why would an OD be more possible?

Fentanyl isn't a dangerous drug when it's accurately measured. The danger from fentanyl comes from the patch form or the fake heroin form. The patch gives you milligrams at a time in a gel of unknown density, and the fake heroin gives you inconsistently mixed powder with hot spots of fentanyl.

I'm going off the first statistic I saw, but the therapeutic index for fentanyl is 270 and for morphine it's only 70.

Being able to snort tiny, measured bursts of the drug with a nasal spray device is probably the SAFEST way to ingest it and it's probably safer than morphine according to the data.
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I said it's very possible for an OD because of my experience with it.

I't never felt the same as poppin a few vicodin or Norco, or even railing Oxy.

Sometimes I felt it fast, others times it seemed I had a high tolerance, or else I wasn't ingesting as much as I thought.

Just like you said about the gel.

So maybe someone feels they didn't take enough to get high, so they squeeze a few more spurts up their nose and bam, OD.

Also, how easy would that be? bam bam bam, 3 sprays in 3 seconds, whereas chasing it on tinfoil at least you have to take a breath before you hit again.

Who knows, maybe it's way safer ROA
 
No, you're not seeming to understand. You would have to take more like 270 sprays to overdose, if 1 is enough to have analgesic effect, based on the "therapeutic index" concept.

Apparently that's for rats, based on their ED50 and LD50, whereas monkeys' LD50 is 0.03mg/kg ... only 300 micrograms will kill the average 10kg rhesus monkey.
 
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Wait, so your saying that the ROA is changing how much is needed to get high?

So this new fangled nose spray requires less than other methods to achieve the desired affects?

I'm sorry, I didn't read anything technical or advanced about it, if thats where your getting at.


Or are you saying that the gel is so hard to accurately measure out even doses, that people don't get high off say 2 smoked hits on tinfoil ROA, and then that next hit is like 20 times more potent than the last, and so they OD. ?

And then the Fent instead of Heroin kills because people think it's Heroin, shoot up waaay too much, or snort, whichever ROA, and thats how that type kills?
 
I think that is basically what I am saying, based on initial research. The fact that there's no known LD50 for humans with fentanyl, rats have a high LD50 and monkeys has a very very tiny LD50 measure in micrograms, makes it hard to guess at.
 
Strap on a patch to ur inner cheek while a sublingual fentanyl pill sits easy under yo tongue while you spray a fat dose of Instanyl up yo nose! = Total nod meltdown or OD. be safe with that shit for sure, i wonder how much the dosage is per spray?
 
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I'm at a loss as to why Fentanyl is the only opioid that continues to be sold in Mad Hatter crazy products.

Actiq, Duragesic/Durogesic, Instanyl, Onsolis. Lollipops, patches full of gel, nasal spray, cheek patch.
 
Theres suppose to be a hydromorphone nasal spray coming out too at some point. Opiate nasal sprays would be awesome
 
It's dangerous due to it's active dosages. I believe the therapeutic index does not take that into account, rather it just considers the LD50 and ED50. So saying it's safe based on that does not make sense.

I'm at a loss as to why Fentanyl is the only opioid that continues to be sold in Mad Hatter crazy products.

Actiq, Duragesic/Durogesic, Instanyl, Onsolis. Lollipops, patches full of gel, nasal spray, cheek patch.
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Yeah, don't forget Fentora. I bet it's just easy to make a very profitable.


I'm not interested in the oral patch, but the nasal spray sounds interesting. What doses will it come in? How easy will it be to shoot? What about evaporating it into a powder? What about using it to lace heroin?
 
phrozen said:
It's dangerous due to it's active dosages. I believe the therapeutic index does not take that into account, rather it just considers the LD50 and ED50. So saying it's safe based on that does not make sense.
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What the hell does the active dose have to do with anything though? It's not like with this you'd be measuring out little bits of gel or getting heroin with fentanyl in it, not knowing how potent it was.

As long as users are using it the way that it's intended, and given it's very fast onset, it'd be super easy to take a few 'hits' wait 5 minutes, see how you're doing, maybe take another one, etc.

For someone with no tolerance at all, it would be a big problem, but someone with a tolerance ought to have no problem, at least if they are okay taking it slow and slowly redosing, since the difference between 2 and 3 snorts won't be as huge as it would be for someone with no tolerance. When I was a newb, 5mg of vicodin would get me good. 10 would have me great, 15 would have me a little queasy.

Shortly after, I was able to take 40mg to start, and if it wasn't strong enough, I could add another 10-15 and though it's 3 more full doses, comparatively, it's not so bad.
 
But thats assuming your average person is competant when it comes to following written directions- which is a big 'If'. Thousands of people die from misunderstanding tablet dosing with Methadone, Oxycodone, etc. And that's as clear cut as "Take 1 tablet every 4-6 hours".
 
I would think that with the intranasal spray there is going to be a greater risk of abuse. Even though they are trusted and tolerant to opiates ..they prolly never had one kick in so quick. With the spray there is a much more high chance of someone to feel a high from it and then start abusing it.
 
Definitely. Speed of onset has a big impact on the recreational potential of a substance.

I wonder if there are studies done using former addicts with Fentanyl products? Such studies have been done with Buprenorphine and various other opioids over time.
 
Hammilton said:
What the hell does the active dose have to do with anything though?
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I was talking about fentanyl itself, while keeping illicit fentanyl in the back of my mind. Sure in a pharmaceutical preparation at the right dose it's safe, but they were discussing its therapeutic index, saying fentanyl isn't as dangerous as everyone makes it out to be because of that.

Taking tchort's post about mistakes in mind, I wonder what OD rates are for fentanyl pharmaceuticals vs other opiate pharms.
 
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