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powerful-narcotic-painkiller-up-for-fda-approval(Moxduo)

phenethylo J

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The Food and Drug Administration is trying to decide whether to approve a powerful new prescription painkiller that's designed to relieve severe pain quickly, and with fewer side effects than other opioids.

The number of babies born with neonatal abstinence syndrome is rising in Tennessee, and lawmakers want to try a punitive approach.

While some pain experts say the medicine could provide a valuable alternative for some patients in intense pain, the drug (called Moxduo) is also prompting concern that it could exacerbate the epidemic of abuse of prescription painkillers and overdoses.An FDA advisory committee is holding a daylong hearing Tuesday to decide whether to recommend that the agency approve the drug.

Moxduo for the first time combines morphine and oxycodone in one capsule. It's designed to provide quick relief to patients suffering severe pain from accidents or surgeries, such as knee replacements, back surgeries or cancer operations, says Ed Rudnic, COO of QRxPharma, the company that makes Moxduo.

The drug allows patients to take lower doses of the two narcotics than they'd need if they took either of the medicines alone, Rudnic says.

"We believe that we've achieved some benefit in reducing the risk of some of the respiratory complications of these strong opioids," he says.

Suppressed breathing and other respiratory complications are the most serious risks of these drugs — the main reason people die from taking too much.

Some pain experts think the idea behind Moxduo is a good one. A lot of patients can't take enough morphine or oxycodone to ease their discomfort because of the risk to breathing and other side effects, such as nausea, vomiting, dizziness and severe itchiness.

Patients who could theoretically benefit from such a pill are "normal people like you and me," says Dr. Joseph Audette of Harvard Medical School. "And then suddenly we get in a terrible accident or have surgery and ... we need something. And the typical agents are used, and suddenly all these terrible side effects come up."

But Audette is not convinced the company has yet proved that Moxduo has fewer side effects.

"They haven't really done the hard work of absolutely showing ... in humans with real pain problems that synergy is making a big difference," Audette says, "compared to just using the agents that we [already] have available."
And some experts worry that Moxduo will come with its own problems.

Hydrocodone, sold as Vicodin and other brand names, may face tighter restrictions on prescribing and use.
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Drug overdose deaths have more than tripled in the U.S. since 1990. Opioid painkillers like OxyContin are the cause of three-quarters of those deaths.


"I have serious concerns about this product," says Andrew Kolodny, an addiction specialist at Phoenix House. He also leads the Physicians for Responsible Opioid Prescribing, which is fighting for tighter control of prescription painkillers.

Millions of people are addicted to these legal narcotics already, Kolodny says, with thousands dying from overdoses each year. Moxduo, he worries, would only make that worse.

"This is pure morphine and pure oxycodone," he says. "This is a product that is very easy to misuse, very easy to crush and snort or crush and inject. So it's significantly more dangerous than the products that it would be competing with," Kolodny. He cites Vicodin and Percocet as competing drugs that contain multiple other ingredients (in addition to a narcotic) that make them more difficult to abuse in those ways.

Patients in severe pain already have plenty of options, he says, and a marketing push to prescribe Moxduo could spell trouble.

"If they get this product put on the market and are able to have a sales force going in and out of doctors' offices encouraging prescribing with the marketing claim that this is somehow a safer product ... I believe that's likely to exacerbate an already severe public health crisis," Kolodny tells Shots.

For his part, Rudnic argues that the manufacturer already has good evidence that Moxduo is a safer painkiller with fewer side effects. And he disputes the claims that Moxduo is easier to abuse.

"I understand abuse and I understand the anguish that some of these people have that have lost a loved one to a drug overdose," says Rudnic. "I lost a brother to a drug overdose in 2002 and it was really tough."

Rudnic promises his company will set up a system to quickly spot any signs that Moxduo is being misused. QRxPharma is also developing a version of the drug, Rudnic says, that would make it harder to abuse.

http://www.npr.org/blogs/health/2014/04/22/302889772/powerful-narcotic-painkiller-up-
 
What the hell? These guys actually got a patent approved just for putting morphine and oxycodone together in a pill?

Everybody's going to want to get their hands on these if they're actually allowed on the market. The 12/8 mg morphine/oxycodone IR pill sounds pretty fantastic. %)
 
These guys actually got a patent approved just for putting morphine and oxycodone together in a pill?

+1 what a joke.. what a fucking joke.. if they are really debating weather the prevention or allowance of this "new" drug will have any effect on the amount of people that use opiates then this shows just how far outta touch they are.. idiots.
 
How can you patent two drugs which are already off patent?
And even the ER versions of both are off patent?

I can imagine combining two would help. Plus it's less easy to abuse than Oxy IR because nasal morphine isn't very good.

Andrew Kolodny should kill himself. He has zero compassion for anyone besides his own ego (and wallet). His PROP group against pain pills should be called CROCK, for crock of shit.
 
I would absolutely love to run some of the bad boys through a wheel filter and inject them. Almost drooling at the thought.

Here's the irony, while I don't really think their logic holds up on a medical level, these would be perfect for IV use. Oxy gives a great high IV, but has a relatively weak ''rush.'' Morphine has a great rush, but the excessive histamine release of higher doses means you spend that rush itchy to the point of pain. Shooting an appropriate dose of one of these would give enough combined opiate for a killer high (with a nice balance between the stimmy oxy feeling and the more sedate morphine), and a decent rush without enough morphine to make you tear your hair out trying to scratch your scalp for the first minute or two.

Funnily enough, a combination of oral morphine and oxycodone (10mg and 20mg respectively) was my first ever strong (ie: not codeine) opiate experience.
 
^I had a different effect.. also if you want a real rush there are far better places to find it than straight opiates.
 
^I had a different effect.. also if you want a real rush there are far better places to find it than straight opiates.

I don't handle stimulants too well these days, if that's what you're referring to. Or are you talking about something else?

Besides, the rush was never my main focus (which is why I had no problems shooting oxy for the majority of my IV career), but it certainly is an added bonus.
 
I'm gonna start working on my patents for random combinations of funscription drugs. My first peice will be 15 mg d-amp, 10mg diazepam, and 30mg hydrocodone for your health; to make one healthy, promote good health.
 
I'm gonna start working on my patents for random combinations of funscription drugs. My first peice will be 15 mg d-amp, 10mg diazepam, and 30mg hydrocodone for your health; to make one healthy, promote good health.
dr. hcl's SUPAR PAIN RELIEF

12 mg diacetylmorphine
75 mg diphenhydramine
45 mg methamphetamine
3200 mg acetaminophen
(all administered intravenously)

ZzzzzzzzzzzzzzzzzzQuil

100 mg diphenhydramine
20 mg doxylamine
3 ml ethanol
2 mg diazepam
(oral)

side effects may include: respiratory failure, heart attack, stroke, being knocked flat on your ass for eight and a half hours, withdrawing from meth and heroin at the same time, and sudden relief of allergy symptoms.

edit: for anyone dumb enough to wonder, the contents of this post have no relation to reality. Please don't ask me for anything.
 
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Evergreening will never never get old....


I'm sure all that abuse-proofing polymer matrix shit had a noticeable effect on profits (lost to various cartels).
The Big Boys gotta keep up somehow.
 
I'm gonna start working on my patents for random combinations of funscription drugs. My first peice will be 15 mg d-amp, 10mg diazepam, and 30mg hydrocodone for your health; to make one healthy, promote good health.

exactly what i was thinking!
yeh these would be pretty perfect for IV use like matey said above. gotta admit I'm surprised they can get a patent for just mixing drugs together that net been done b4.
 
Wouldn't mind trying one of those morphine and OXY.
To bad, it's an interesting concept for taking both drugs together. I wish they would spend more time tuning the way two drugs effect each other because i swear my buprenorphine is effected when i take my vyvanse.

This is a radio interview about the above topic.
Not sure if this link was different than your blog link, just sharing..
http://www.npr.org/blogs/health/201...-vote-against-approving-new-opioid-painkiller
 
I rather my doc perscribe me morphine and oxycodone individually to control each individual drug's effects better to my own personal need. Not to mention this is clearly a money grab. Why not use two non patented drugs and make money off them again?
 
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