King wins OK for morphine meant to thwart abuse

[AfterGlow]

* Drug meant to deter abuse of long-acting morphine

* Approved to treat moderate to severe pain

* Shares rise 2 percent in after-market trade (Adds analyst, FDA comments, updates shares)

By Ransdell Pierson

NEW YORK, Aug 13 (Reuters) - King Pharmaceuticals Inc (KG.N) on Thursday said U.S. regulators had approved Embeda, its pain medicine meant to help thwart abuse by those who crush or chew long-acting opioid drugs to get a euphoric but dangerous high, lifting company shares 2 percent.

The morphine-based drug was approved to treat moderate to severe pain when a continuous opioid painkiller is needed over an extended period. It will be available in either once- or twice-daily dosages.

Embeda contains extended-release morphine pellets wrapped around naltrexone hydrochloride, a drug that counteracts the effects of morphine, which is an opioid.

"If taken as directed, the morphine relieves pain while the sequestered naltrexone hydrochloride passes through the body with no intended clinical effect," King said in a release.

But if crushed or chewed, the naltrexone is released and absorbed with the morphine, King said, to some extent reversing morphine's effects.

"The clinical significance of the degree of this reduction has not been established," King cautioned in a release, and the company also noted that there is no evidence that the naltrexone in Embeda reduces the risk of abuse.

Although Embeda is the first U.S.-approved long acting opioid designed to counter such abuse, King cautioned it still carries risk.

"Because Embeda is an extended-release product, it should not be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine," King said.

The FDA, in a statement, said intravenous injection of crushed Embeda can cause serious injury or death due to a morphine overdose or blood blots.

Robert Hazlett, an analyst with BMO Capital Markets, predicted Embeda would garner peak annual sales of $400 million even though questions remained as to whether the drug was thoroughly tested.

Hazlett boosted his 2010 earnings forecast for King by 2 cents per share, to $1.22, saying Embeda will likely wrest sales away from the company's already marketed Avinza brand of morphine. The company has total annual sales of about $1.8 billion.

King acquired Embeda as part of its $1.6 billion deal for drugmaker Alpharma. King is counting on Embeda and a number of its other drugs now in development to help it become a leader in the field of abuse-resistant painkillers, which it hopes will offset slower sales of drugs such as its Altace blood pressure medicine.

The U.S. Food and Drug Administration in December declined to approve Remoxy, King's long-acting version of the potent oxycodone painkiller being developed in partnership with Pain Therapeutics Inc. (PTIE.O)

The companies last month said they may not resubmit their marketing application for Remoxy until the middle of next year.

Shares of King rose to $10.79 in after-hours trading, from their closing price of $10.59 Thursday on the New York Stock Exchange.

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[paranoid android]

If im correct this will never hit the market up here in canada right? I don't think they can add naltrexone or naloxone to any opiates/opioids in canada. Hence why we never had talwin NX here only talwin. Or i could be completely wrong on that.

In anycase since naltrexone is active orally isint there always the danger of sending someone who takes their meds for legit purposes into withdrawal? I wonder if this med will flop completely.

 

[Tchort]

That's right, p_a. You also don't have Lomotil for that reason (Diphenoxylate/Atropine). A drug cannot be added to a medication without a valid medicinal reason. Meaning, a drug company can't put a drug into a product to harm someone for using it improperly (as is the case of Lomotil).

You do have Suboxone up there though, right? I wonder why Suboxone is allowed, but not Talwin NX or Lomotil.

Anyway, I hope that these pills are easy to defeat. I remember reading about Embeda awhile back. Actually, I made a thread on the load of 'anti-abuse' opioid medications coming out soon:

They're going too far.

All for naught, as well. All for fucking naught.

It all started with Talwin; a few low-level healthcare workers came up with the T's & Blues combination, and shooting Pentazocine (which was unscheduled at the time) and Pyribenzamine (a.k.a. Tripellenamine, a common Rx cold/flu anti-Histamine of the day) spread across the country.

Then it started: Talwin NX. Pentazocine and Naloxone, combined in one pill. To stop intravenous abuse, they said. And it did: only, abuse never stopped, it just switched to oral and insufflation. A new combination was then discovered to be adequately euphoric to abuse: Talwin NX and Ritalin.

All was quiet for a couple decades, then Reckitt-Benckiser hit the lottery with their orphan drug Buprenorphine, owning the patents and branding rights for all of the Bupe products. The magic bullet that made this fortune and fame possible? Narcan. Add some, make money.

Suboxone; how a Big Pharma company reversed 80 years of American narcotics policy, the first bargaining chip at the peace table of the War On Doctors started in the '20s after the Supreme Court ruled on how to enforce the Harrison Act (by locking up doctors who prescribe narcotics addicts narcotics).

And how did they manage to take that giant step against the American Opiophobia? Put some Narcan in it.

Seriously. It worked for T's & Blues, remember? See, Pentazocine, Buprenorphine, both partial agonists, both have a long history of IV abuse and addiction, Naloxone cured the IV Talwin problem, we will prevent IV abuse of our Buprenorphine product from ever starting by putting the Narcan in first.

Sealed the deal; the FDA bought it. Only, no one ever thought to do bioassay tests on actual addicts, or run a trial on the drug use and abuse habits of sublingual Buprenorphine/Naloxone maintained patients (Come on, honestly, I know I'm not the only Suboxone patient who shot up his pills when everyone said the Naloxone would definitly cause precipitated withdrawals).

Doesn't matter though, Buprenorphine/Naloxone, the holy grail the drug warriors and drug czars of old were searching for, Suboxone, isn't half the myth they make it out to be.

But we forget the most important thing: it made Reckitt-Benckiser a mint. Europe had already accepted Buprenex, Subutex was just as readily jumped on without a hitch. Huge junk addict market in Europe to pry on, they didn't need the US and the rest of the world to make all that cash. But they did it anyway, Suboxone opened that door, and following suit parts of Asia followed us into Suboxone prescription maintenance (ask India and Bangladesh how well thats going now).

Anyway, thats the lead-up. Heres the point of the story:

Now that two working examples of narcotic/Narcan combination products are slick deal-makers in the American Big Pharma, Federal agency shakedown game, every other mom & pop pharmaceutical company is jumping on board with a Dope/Narcan product:

And they are getting approved! And funding! With excellent sales and profits projections!

The proof:

OXYTREK

While not Naloxone, it's still an antagonist, Naltrexone. Brought to us soon by Pain Therapeutics.

Oxycodone + Naltrexone in a pain relief pill.

Pain Therapeutics' oxycodone/naltrexone combination, OxyTrek. Factors driving the market rebound will include the premium pricing of these new therapies compared with current options, most of which will be available generically by the time the new drugs are launched.

"Improving on the significant side effects of analgesics is the near-term opportunity for drug developers, as it has been for many years, and a few companies will succeed in providing incremental improvements in safety or tolerability, despite the recent dramatic changes in the regulatory landscape," said Michelle Grady, therapeutic area director, Pain Management, at Decision Resources, Inc.

Meaning: "We're gonna make a ton of fucking money duping the government, the patients and the addicts"

The bells tolls already for OxyTrek:

Outcome Measures for this Clinical Trial

Primary Measures

The primary objective of this study is to evaluate the subjective effects of PTI-801 formulated with either 0.001 mg naltrexone or 0.0001 mg naltrexone compared to oxycodone alone in individuals with a history of opioid abuse.
Time Frame: At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose

Secondary Measures

Secondary objectives include determining the safety and physiological effects of single doses of PTI-801 compared to oxycodone following oral administration in individuals with a history of opioid abuse.

Straight from the studies mouth, my moneys on results from this abuse liability tests putting OxyTrek well below likability for plain Oxycodone, in those w/o a history of opioid abuse and those with a history of opioid abuse.

Less abusable, less desirable, cause they put the antagonist in it. See? Easy. $$$

http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00734461

Number 2:

EMBEDA

Morphine + an antagonist (which one is not known yet)

This is a juicy story.

Alpharma has asked the Food and Drug Administration to approve Embeda as a tamperproof medication for patients with moderate to severe chronic pain. The pills are formulated so that the euphoric effects of morphine are blocked when a patient crushes, dissolves or chews them. Patients often abuse pain pills by grinding them up to snort or inject.

Same old story, add antagonist, dope not so good to dope fiends, no addiction, better pain management results in old people, etc etc etc

BUT- in the same breathe that they ask for funding:

If Embeda is approved it would help offset lost sales of Alpharma's morphine drug Kadian, which is expected to lose patent protection in 2010. The drug was Alpharma's best-selling product last year with sales of $167.7 million.

Rival drugmaker King Pharmaceuticals Inc. (nyse: KG - news - people ) is trying to buy Alpharma for $37 per share, or about $1.6 billion. Sanderson said that if Friday's panel meeting goes poorly, King could drop that offer, which would sink shares of Alpharma. However, he said that outcome is unlikely unless the FDA panel "absolutely rejects" Alpharma's application, which is not expected.

Shares of Alpharma rose $1.81, or 6.3 percent, Wednesday to close at $30.66.

I don't think I need to add the Pharmaceutical/Industrial Complex commentary on that one. Same story as Suboxone, Talwin NX and soon OxyTrek: Make a mint with a new medication to brand and have exclusive patent rights to, get great publicity and approval from the gov't / medical authorities for making a less addictive, less abusable, abuse-resistant, etc product. Stock manipulation by slightly altering the best selling product, create a competitor for your own product, make more money on your products by making more money on your products- a brilliant plan.

So, thats it people. First a trickle, here comes the flood.

Combination Agonist + Antagonist opioid medications are the future, thanks to Big Pharma and the crooked insider-trading-esque laws we have regarding pharmaceutical branding, patents and distribution rights.

Don't worry though, as with every other "less addictive", "tamper-proof" pill they make, we will all still be able to abuse, shoot, snort, parachute, plug, smoke, and combine these new and yet to be developed pills and formulations.

After all, they're counting on it, all the way to the fucking bank.

http://www.bluelight.ru/vb/showthread.php?t=410997&highlight=big+thing+pain

 

[paranoid android]

Well fuck me we do have lomotil in canada. I was totally unaware of this and i have never seen a script for it in my life. Maybe your only allowed to add this stuff under certain conditions? We do have librax here which is sorta the same thing except it's a benzo mixed with a anti-cholinergic.You could make a case in point that the atropine in lomotil has some medical value but theres no arguing that talwin NX exists just to prevent abuse. Hycodan here also does not have a anti-cholinergic like it does in the US.

But then again you are right T-chort we do have suboxone here as well (atleast in the places it's available so far) and there is no arguing a valid medical reason for that. It's just there in a stupid attempt to prevent abuse.

If anyone has better knowledge about all of this canadian drug laws then PM me or something. I don't fucking want naltrexone in my MScontin .

 

[JahRed24x]

what so they are going to but naltrexone in extended release morphine pills? lol aren't morphine pills pretty low on the euphoric range anyways? I mean its oral BA is so shitty its practically worthless. screw morphine.. But yeah dude sooner or later they are going to find other chemicals that provide 'pain relief' with no euphoria at all.

 

[Dragynfyr]

^That's the holy grail project I'd like to be able to work on one day. A non-euphoric pain killer that cut's pain off at the source, instead of just chaning how we procieve it.. *sigh* it'll come..

Opiate's arn't goin anywhere even when we do find the grail though, don't worry =p lol



Something about this new pill combo just sounds really dangerous to me.. I see a lot of deaths comming if they released something like this..

 

[paranoid android]

I love morphine pills ive spent hours noddin in and out on them. I can see alot of people accidentally being thrown into withdrawal with these pills. The naltrexone is active orally so if the pill is crushed even abit wouldnt that release it?