ALO-02 and Embeda

LOL. A generic opioid extended release for $5? What commercial plan are you smoking?

Also when it comes to opioids the therapeutic windows get tighter with patients over time. The generics are inherently INaccurate by regulation. From generic manufacturer to generic manufacturer and from batch to different batch the molecular accuracy/potency are drastic. It's a fact. Many patients get more or less of the pain killer in every pill. Not so with branded drugs as a matter of law.

For approximately $10 more or less per month the patient will get 99.9% molecular accuracy/potency and the doctor has nearly covered his ass, liability wise, by just Rxing Embeda.

It's not rocket science folks, just plain common sense and good medicine.

 

You're preaching to the choir, but you know what patients do, dontcha? They get a script for generic immediate release and take a million pills a day. Sure the ER formulation is great but patients would rather pay less.

 

As a former King employee, all I can say is "Thank you Pfizer for taking this load of opioid shit off our hands!" We were not an opioid company, just puffed up to look like one when Pfizer unknowingly grabbed us, and laid us all off. Four years later, all we can say is Thank you! Thank you! Thank you! Here's hoping that AD-ER morphine, hydrocodone, hydromorphone, and an abuse deterrent form of Oxy-clean will bring you all the riches that you deserve! LOL

 

Many patients want the "million IR pills a day" because they don't need them or take them prn conning the doctor all the way to the bank. They sell those extra pills on the side.

The doctors look the other way or lie to themselves that their patients don't abuse the opioids. They can lie to themselves all they want, but when their State's Attorney General gets a hard on for going after these deluded doctors nailing them for pill milling and not Rxing the "apparently" safer, smarter choice of ER with abuse deterrent labeling by the FDA, they might get the message a little too late.

Doctors moan constantly about being sued, losing their licenses, or going to jail for some lame medicare mistake, yet they take their sweet ass time not switching their patients to ER abuse deterrent labeled opioids, especially when it's only a few more dollars out of the patients' pockets and no skin off the doctors' asses??????

You'd think the doctor might put his license and future over the possibility of a few drug dealers they call patients who might leave them if they get only RXed ER abuse deterrent opioids?!?!? Nope, they sit on their butts like it's business as usual, even when they see their colleagues sued or hauled off to jail.

The more I sell this drug the absolute more I am convinced most doctors are full of shit, in one way or another, about their "fear" of lawsuits and law enforcement. If I was an opioid prescribing doctor, I'd do everything I could to switch my patients over. Why they don't is almost laughable if the drugs weren't so dangerous when abused.

But hey, I'm just a koolaid drinker sucking on the ELT's teat. What the hell do I know?

 

I can see doctors preferring an AD opioid over a generic opioid only if the AD opoiid was shown to be "safer" than its counterpart. Otherwise, it's just a patient preference vs prescription cost issue. A pig in a poke as they say.

 

I recently had shoulder surgery that required a prescription pain med post surgery. Before rxing the drug the doctor HAD to go to the state website that had my pain med "history" listed to see how many scripts I had been prescribed, was I doctor shopping, etc. If there was anything suspicious there there would be no script given. It was post surgery so of course it was legit. If I was just looking for a script to fill to sell (or take) recreationally it would show up on the website. Tough in my state to get sued if you follow protocol. Not sure what they do in other states.

 

You are not a candidate for ER extended release opioids, so you're point is moot concerning Embeda.

As for the previous poster's "safer" point, WHEN THE FDA OFFICIALLY AND FORMALLY DEEMS THE OPIOID AS AN ABUSE DETERRENT FORMULATION, IT IS SAFER FOR THE DOCTOR'S LICENSE AND FOR THE PATIENTS WHO MAY HAVE A LOVED ONE OR ROOMATE WHO STEALS THEIR PILLS.

 

Good for you! Now that the vast majority of former King employees have rebounded, we can laugh about Pfizer's mis-adventure into opioid$.

There is hope for you too, Hospira!!!

 

Still laughing at you, Pfizer. Laughing all the way to the bank! Hope you find it funny too, Limpwack. Ahhh hahaha!!!

Sherlock

 

Maybe if Litwack apologized for the shifty way he ran the opioid program, like a jerk!, this site would not show so much hostility toward him.

 

No way. Don't tell him that, idiot. It's too much fun bitch slapping the man for fu__in up the opioid program. I say, give him and Donevan another program to fck up.

 

It's all smoke and mirrors. The street chemists will find a way to abuse this like everything else.
There is no such thing as a safe opioid in the hands of an abuser. Pfizer is scraping the bottom of the barrel on this one. Smoke and mirrors.

 

Is it true that Pfizer just received a deficiency letter from FDA that describes naloxone leakage and withdrawal as a problem?

 

This is nothing new. Nalbuphine, Trexan were around 30 years ago. The original Endo labs had some great narcotics.
Opioids are NOT for chronic pain. Never will be. For acute pain there is nothing like them, for long term pain, they are poison. Once tolerance develops, it's a quick move to habituation.
Abusers will find a way to ruin the usefulness of any good pain reliever. Too many of these losers in the world. Finally a use for the planet Mars and all the wasted money on space exploration. They'll probably find something there to smoke, snort, or inject.

 

No. Embeda has naltrexone, not naloxone. Huge difference.

Targiniq has naloxone. It is not a Pfizer product.


As for street chemists.....none so far have defeated Embeda. You tell us how to separate the naltrexone from the morphine??? It's virtually impossible. Imagine the cost of experimentation to accomplish this? Is that feasible for a backyard street chemist?

It's just so much cheaper to just lie to your doctor that Embeda doesn't work so you can get your crushable and snortable morphine generics back.

This is exactly why Embeda must be prescribed over the non abuse deterrent morphines.

 

They find ways of getting high with banana peels, glue, bath salts, you name it they find it.
Embeda will have as much habituation as any other opioid; its only a a matter of time.

 

You are smoking crack. You make no sense at all.

Habituation means what? We're talking abuse deterrence. Anyone can take more pills than prescribed or become "habituated", by that do you mean "build up tolerance"?

If so, then you're statement is useless. Care to generalize about nothing some more?

 

Old story, but there may be hope.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced top-line results today from a Phase 3 open-label long-term safety study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, non-cancer pain. The primary objective of the study was to evaluate the safety of ALO-02 administered for up to 12 months. The study showed that the adverse event profile was as expected based on similar long-term safety studies with other extended-release opioid formulations; the most common adverse events were nausea, constipation, vomiting and headache. The study supports the safety profile of this investigational analgesic.

ALO-02 uses technology designed to encourage use as intended. The technology may discourage common methods of tampering associated with prescription opioid misuse and abuse and consists of extended-release oxycodone pellets that surround a sequestered core of naltrexone. When used as directed, the naltrexone core remains sequestered and patients receive oxycodone in an extended release manner. When the pellets are crushed, the naltrexone is released and is designed to counteract the effects of oxycodone.

“These top-line data provide evidence of the long-term safety of ALO-02 in patients with moderate-to-severe non-cancer pain regardless of prior prescription opioid treatment,” said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc.

Study ALO-02-10-3001 included adult patients with moderate-to-severe chronic non-cancer pain lasting at least 3 months and requiring a continuous around-the-clock opioid analgesic for an extended period of time. Before enrolling in the study, subjects could be receiving a prescription opioid for the management of chronic pain or could be opioid-naïve. The primary objective of this single-arm, multicenter, safety study was to evaluate the long-term safety of ALO-02 administered once or twice daily for up to 12 months. The study enrolled 395 patients, the majority of whom – 77 percent – were opioid-experienced. The majority of patients had chronic lower back pain (61 percent) and 18 percent had pain from osteoarthritis. Patients enrolled in the study had pain for an average of nine years. A total of 193 (48.9%) patients received ALO-02 for approximately 6 months and 105 (26.6%) patients for approximately one year.

The most common treatment-emergent adverse events (>10%) while on ALO-02 were nausea, constipation, vomiting and headache. The most common serious adverse events were acute myocardial infarction, non-cardiac chest pain, pneumonia, convulsion, and kidney stones, each of which occurred in 2 patients. A total of 237 (60%) patients discontinued from the study over the one-year study period, with 19 percent of patients reporting adverse events as the primary reason for discontinuation. The adverse events that most commonly (>2%) lead to discontinuation were nausea and constipation. The discontinuation rate was within the expected range based on similar long-term safety studies with other extended-release opioid formulations.

 

Do you mean problems with ALO-02 induced opioid withdrawal???

 

Neither do you. You regurgitate the company line....all bullshit. Wait and see.