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 veggie
Registered: 07/26/04
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 FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain 
#13764243 - 01/10/11 05:56 PM (2 years, 4 months ago) |
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FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain
January 10, 2011 - medscape.com
The US Food and Drug Administration (FDA) has approved an immediate-release transmucosal tablet formulation of fentanyl (Abstral; ProStraken, Inc) for the management of breakthrough cancer pain in patients aged 18 years and older who receive around-the-clock opioid therapy and are able to safely use high doses of additional opioid agents.
"This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain," said John Jenkins, MD, director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research, in an agency news release.
Common adverse events reported in a study of 311 opioid-tolerant patients with cancer included nausea, constipation, drowsiness, and headache. Serious adverse events, including death, have been reported with inappropriate use or improper dosing of other immediate-release transmucosal fentanyl formulations.
Because fentanyl is a schedule II opioid subject to abuse and misuse, the product was approved with a risk evaluation and mitigation strategy (REMS) that includes a restricted distribution program requiring registration of prescribers, pharmacies, and patients.
The program, which is to be shared by all makers of immediate-release transmucosal fentanyl products, emphasizes the need for clinician and pharmacist education and patient counseling regarding the attendant risks of therapy.
"This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs," added Dr. Jenkins. "When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS."
Previously approved oral formulations of fentanyl include transmucosal troches/lozenges, buccal tablets, and buccal films. Fentanyl is also available in patch and injection forms.
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 aiyobro
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: veggie]
#13764687 - 01/10/11 07:33 PM (2 years, 4 months ago) |
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more useless shit approved by the goverment
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DoseInTheWoods3420
LSD Connoisseur
Registered: 10/07/09
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: aiyobro]
#13764916 - 01/10/11 08:29 PM (2 years, 4 months ago) |
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instant release fent???
sounds like od's are going go up thru the roof
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You're either on the bus, or off the bus!
AIM= DoseInTheWoods
everything i say is complete and utter bulshit 
getting started on that abelton shit real soon. look out midwest
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badchad
Mad Scientist
Registered: 03/02/05
Posts: 9,136
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: aiyobro]
#13765118 - 01/10/11 09:05 PM (2 years, 4 months ago) |
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Quote:
aiyobro said:
more useless shit approved by the goverment
Hell yeah, screw those people with cancer pain. They deserve it.
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...the whole experience is (and is as) a profound piece of knowledge. It is an indellible experience; it is forever known. I have known myself in a way I doubt I would have ever occurred except as it did.
Smith, P. Bull. Menninger Clinic (1959) 23:20-27; p. 27.
...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.
Osmond, H. Annals, NY Acad Science (1957) 66:418-434; p.436
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aiyobro
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: badchad]
#13765195 - 01/10/11 09:16 PM (2 years, 4 months ago) |
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it doesnt say it cures cancer does it?
what does it cure honestly, it removes pain and promote comfertableness?(diarreah, heacache, nausea, possible death)
sounds like fucking poisen
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Raw
Muslim
Registered: 03/23/10
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: aiyobro]
#13765251 - 01/10/11 09:23 PM (2 years, 4 months ago) |
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Why not just provide 100% organic sativa sensi herb to people who have cancer for free?
fentanyl is scary stuff... it is not like they can function on that stuff anyway.
Quote:
aiyobro said:
it doesnt say it cures cancer does it?
what does it cure honestly, it removes pain and promote comfertableness?(diarreah, heacache, nausea, possible death)
sounds like fucking poisen
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benton
Psyborg
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: Raw]
#13765476 - 01/10/11 09:57 PM (2 years, 4 months ago) |
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Give me a break. Leave it to a stoner to try to compare the pain relieving qualities of marijuana to fucking fentanyl. Jesus, these people don't get the occasional migrane or tummy ache, they are living in constant, horrendous pain. Some people actually use the medecine for its intended purpose.
On a sidenote, hope I can get my hands on these. 
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idunno
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: veggie]
#13765478 - 01/10/11 09:58 PM (2 years, 4 months ago) |
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My ? is how much faster do the Patients need really? They have fent suckers, patches, Ir oxy now they basicly have IR (SNORTABLE)fent? Trans mucal? Either in the eye,or nose-right- SO now we have childrens snortable Fentanyl - And they thought oxy was killing kids-
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benton
Psyborg
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: idunno]
#13765562 - 01/10/11 10:14 PM (2 years, 4 months ago) |
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How is it children's all of the sudden? It says approved for 18+
Secondly where does it say thats its snortable. Transmucoal implies mucous membranes of the mouth/cheek or somewhere in the digestional tract. These are not going to be roxicodones, definitely a gel type preperation.
It makes sense. There are life-time opiate users with 20+ year tolerances who use strictly fentanyl by this point and are sick of sucking on fucking lolipops and putting on patches and want a known, instant dose of the drug.
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Cognitive_Shift
@shroomery.org
Registered: 12/11/07
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: DoseInTheWoods3420]
#13766522 - 01/11/11 01:03 AM (2 years, 4 months ago) |
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Quote:
DoseInTheWoods3420 said:
instant release fent???
sounds like od's are going go up thru the roof
Not if taken as prescribed.
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Cognitive_Shift
@shroomery.org
Registered: 12/11/07
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: Raw]
#13766528 - 01/11/11 01:05 AM (2 years, 4 months ago) |
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Quote:
Raw said:
fentanyl is scary stuff... it is not like they can function on that stuff anyway.
I agree cannabis should be prescribed for pain resulting from cancer, but if fentanyl helps breakthrough pain why not give it to them? You think they can function in that pain with out narcotics?
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aiyobro
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: Cognitive_Shift]
#13766703 - 01/11/11 01:46 AM (2 years, 4 months ago) |
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Education and Recovery Based Sentencing
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Jordan2Dope
Marijuana Man
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: aiyobro]
#13767995 - 01/11/11 12:20 PM (2 years, 4 months ago) |
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This shit is NOT useless....
If not for the patches...my sister wouldn't be able to live a normal life.
Weed can only do so much for pain...lol.
You can function fine on it...if you have true pain.
People who seek a high with this stuff...will surely get it.
I dunno what my sister would do without this....she was born with her spine outside of her back. Spina Bifida.
Edited by Jordan2Dope (01/11/11 12:21 PM)
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SpawnRun
Morchella esculenta
Registered: 11/12/10
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: Jordan2Dope]
#13768171 - 01/11/11 01:08 PM (2 years, 4 months ago) |
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SPina Bifida is nasty, a close friend has it. I have degenerative disc disease, 2 herniated discs, and one pinched nerve so I can speak about pain. I sometimes have pain so bad that I've sat in a room, with a gun in my mouth, praying for relief. Some people really do need strong painkillers. Period.
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Quote from Allan Rockefeller:
Dictyophora indusiata;
According to a 2001 publication in the International Journal of Medicinal Mushrooms, the smell of the fresh fungus can trigger spontaneous orgasms in human females. In the trial involving 16 women, 6 had orgasms while smelling the fruit body, and the other ten, who received smaller doses, experienced physiological changes such as increased heart rate.
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benton
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: SpawnRun]
#13768428 - 01/11/11 01:55 PM (2 years, 4 months ago) |
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Wow spawn thats terrible man, best of luck to you.
And thanks for these anecdotes, nothing gets me more frustrated than stupid hippies coming in here being like noooo mannn all you need is the herbbb mann and maybe rub a little oatmeal on it and see a shaman broo.
Obviously these people have never experienced the pain that fentanyl is designed for. Just because people abuse prescription drugs doesn't mean that's their only purpose.
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Knewnews
Thinking XXX but only AA
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: benton]
#13768665 - 01/11/11 02:30 PM (2 years, 4 months ago) |
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i don't think people on here are ignorant of severe debilitating pain, they are just looking from the outside in from the view of a recreational drug user.
therefore they see the inevitable abuse as more topic worthy then the small percentage of people who will use these because they need them.
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Raw
Muslim
Registered: 03/23/10
Posts: 1,419
Loc: USA West Coast
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: Knewnews]
#13771196 - 01/11/11 09:59 PM (2 years, 4 months ago) |
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If someone is in that much pain I hope it helps em out.
Quote:
Knewnews said:
i don't think people on here are ignorant of severe debilitating pain, they are just looking from the outside in from the view of a recreational drug user.
therefore they see the inevitable abuse as more topic worthy then the small percentage of people who will use these because they need them.
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Sandoz
Ridin that wave
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Re: FDA Approves Fentanyl Transmucosal Tablets for Cancer Pain [Re: Raw]
#13771833 - 01/11/11 11:52 PM (2 years, 4 months ago) |
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FDA send me a perscription for them and i will guniea pig for you. Try it on someone healthy and ill do in the name of science...
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