Generic Opana-people Speak Up (Page 7)
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They are saying that the new opana works as well as the old. There are so many peoples statements that I have read saying the new don't work as well but yet Endo states their research don't prove that. All people who have a real medical problem that causes pain and takes new opana and it doesn' work as well as the old needs to speak up. One person can't change anything. People who are being treated awful by medical doctors and pain clinics because they have pain also need to speak up.

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REPORT

Endo didn't win their law suit for now. Impax has already started sending out the generic opana to the reps for the pharmacies. Your pharmacy may have to order it because it is so new. CVS can't order it yet but others can. Please don't abuse it or if you know anyone who has tell them not to so people who need it for health problem pain don't lose their meds again. Endo is just waiting to show it will be abused again and cause deaths. Thank you and good luck and hope your pain eases up.

FYI:
January 04, 2013
Impax Launches Generic Opana ER Tablets

Impax announced the launch of Oxymorphone HCl Extended-Release Tablets, the generic version of Endo's Opana ER. Opana ER is indicated for moderate to severe pain when the use of a continuous, around-the-clock opioid is required for an extended period of time; not for "as-needed" use.

Oxymorphone, an opioid agonist, is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses. Specific central nervous system (CNS) opiate receptors and endogenous compounds with morphine-like activity have been identified throughout the brain and spinal cord and are likely to play a role in the expression and perception of analgesic effects.

Impax is commencing shipment of Oxymorphone HCl Extended-Release Tablets through Global Pharmaceuticals in 5mg, 7.5mg, 10mg, 15mg, 20mg, 30mg, and 40mg in 30-, 100-, and 1000-count bottles.

For more information call or visit impaxlabs.com.

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Generic Er has been launched by Impax Jan. 4, 2013. Check out their web site. Call them, they will tell you.

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I don't know how hard Activis had to fight to product generic opana 7.5 & 15 after you read the notice I found Endo sent out. Also, did you know now that Endo has now made 7.5 & 15mg ER's available in the new abuse free? Let the doctors decide if their patient needs the old or new. Everyone's doctors should decide what meds we take anyway, that's why they spend all that money and time going to college. They get paid good. Anyway, does anyone know how that works with doctors when they write a script for a patient, do they get any money for writing that from the drug companies? The doctors are suppose to know us as patients and know what helps us. They know our records. We are suppose to trust them. I would rather ask them than someone I don't know and don't know me or my health issues.

I found this from Endo. Just last Feb. 2011 they sent or posted this. They weren't worried about opana being not safe back then. How long do you think they were working on the new abuse free opana? In Dec. 2011 it was approved and it was available March 2012 with the old formula getting ready for the patent to expire, but yet just months before that they give up 7.5 and 15mg and giving another drug company rights to make generic of those two and Endo focusing on the strengths that was most used. They state that in this letter. If all drug companies can do this when their patents are getting ready to expire they are going to do it with all drugs to make more money, not just pain medicines, it will be all meds that people most need for heart, blood pressure, anti depresses etc.

FYI
February 2011
Re:
Discontinuation
7.5 mg and 15 mg OPANA® ER (oxymorphone H Cl) Extended-Release Tablets CII

Dear Valued Customer:

Please be advised that Endo Pharmaceuticals will discontinue the sale and distribution of two
strengths of Opana ER (oxymorphone HCl) Extended-Rellease Tablets CII. Endo estimates these
two strengths will no longer be on retail shelves on or about May 01, 2011.

63481-0522-70
5

63481-0553-70
5
Due to increased demand for Opana ER, Endo is streamlining operations to focus on the most
commonly prescribed dosages, enabling us to serve the needs of our customers while continuing to a
supply a wide range of dose strengths. Opana® ER dose strengths of 5 mg, 10 mg, 20 mg, 30 mg
and 40 mg will continue to be available at your local pharmacy. Your patients can call 1-888­
222-9845 to locate the nearest pharmacy stocking their prescribed strength of Opana ER.
Please see the enclosed full Prescribing Information including boxed warning for Opana® ER.
We thank you for your continued support of Endo Pharmaceuticals Inc. If you have any questions
please consult with your local Endo Pharmaceuticals Sales Representative or contact the Endo
Pharmaceuticals Customer Service at 1-800-462-ENDO (3 636).

Sincerely,
Product
Opana® ER (oxymorphone HCl) Extend-Release Tablets CII
15
Opana® ER (oxymorphone HCl) Extend-Release Tablets CII
Description
7.5 mg
15 mg
Packaging
100 ct. Bottles
100 ct. Bottles
A. Demir Bingol
Senior Director, Oral Pain Solutions
February 2011
Re:
Discontinuation
7.5 mg and 15 mg OPANA® ER (oxymorphone H Cl) Extended-Release Tablets CII

Dear Valued Customer:

Please be advised that Endo Pharmaceuticals will discontinue the sale and distribution of two
strengths of Opana® ER (oxymorphone HCl) Extended-Rellease Tablets CII. Endo estimates these
two strengths will no longer be on retail shelves on or about May 01, 2011.

63481-0522-70
5

63481-0553-70
5
Due to increased demand for Opana ER, Endo is streamlining operations to focus on the most
commonly prescribed dosages, enabling us to serve the needs of our customers while continuing to a
supply a wide range of dose strengths. Opana® ER dose strengths of 5 mg, 10 mg, 20 mg, 30 mg
and 40 mg will continue to be available at your local pharmacy. Your patients can call 1-888­
222-9845 to locate the nearest pharmacy stocking their prescribed strength of Opana ER.
Please see the enclosed full Prescribing Information including boxed warning for Opana® ER.

We thank you for your continued support of Endo Pharmaceuticals Inc. If you have any questions
please consult with your local Endo Pharmaceuticals Sales Representative or contact the Endo
Pharmaceuticals Customer Service at 1-800-462-ENDO (3 636).

Sincerely,

Product

Opana® ER (oxymorphone HCl) Extend-Release Tablets CII

Opana® ER (oxymorphone HCl) Extend-Release Tablets CII
Description
7.5 mg
15 mg

Packaging
100 ct. Bottles
100 ct. Bottles

A. Demir Bingol
Senior Director, Oral Pain Solutions

Merry Christmas and have a safe New Year!-Silver

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This is just a page of news about Endo & Opana for the past couple of years.
FYI
Content about Oxymorphone
June 12, 2012
HDMA names 2012 DIANA recipients
The Healthcare Distribution Management Association on Tuesday honored 10 pharmaceutical and consumer product manufacturers through the presentation of its annual Distribution Management Awards for Notable Achievements in Healthcare, or DIANA. The winners were announced Monday evening at the Association’s 2012 Business and Leadership Conference in San Antonio, Texas.
January 9, 2012
Endo addresses possible short-term supply of Opana ER, other drugs
Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.
December 12, 2011
FDA approves crush-resistant painkiller by Endo

The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.
August 9, 2011
Endo sales, profits climb in Q2
Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.
June 24, 2011
FDA accepts Endo's resubmission for Opana ER
The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.
January 10, 2011
Endo receives complete response letter for crush-resistant Opana ER
The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.
November 1, 2010
Generics lift Endo’s 3Q
Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted....
October 6, 2010
Watson, Endo settle Opana ER patent suit
Watson Pharmaceuticals has settled a patent lawsuit with Endo Pharmaceuticals concerning an Endo prescription painkiller,...
September 21, 2010
FDA grants priority review for crush-resistant, long-acting oxymorphone

The Food and Drug Administration has granted priority review to an opioid painkiller designed to...
August 8, 2010
Endo to acquire Penwest for $168 million

Endo Pharmaceuticals will acquire Penwest Pharmaceuticals for $168 million, Penwest said Monday....
November 1, 2010
Generics lift Endo’s 3Q
Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted....
October 6, 2010
Watson, Endo settle Opana ER patent suit
Watson Pharmaceuticals has settled a patent lawsuit with Endo Pharmaceuticals concerning an Endo prescription painkiller,...
September 21, 2010
FDA grants priority review for crush-resistant, long-acting oxymorphone
The Food and Drug Administration has granted priority review to an opioid painkiller designed to...
August 8, 2010
Endo to acquire Penwest for $168 million
Endo Pharmaceuticals will acquire Penwest Pharmaceuticals for $168 million, Penwest said Monday....

June 7, 2010
Endo, Penwest grant Opana ER license to Impax
will grant Impax Labs a special license to sell a...
May 16, 2010
Impax receives tentative approval for generic Opana ER
The Food and Drug Administration has given tentative approval to an Impax Labs drug for...
March 8, 2010
Watson seeks approval for generic Opana
Watson Pharmaceuticals has filed a regulatory approval application for a generic version of a painkiller...
February 22, 2010
Endo reports 2009 profits
Endo Money, Money,Money,Money,Money,Money
Endo Pharmaceuticals saw profits of $334.3 million in 2009, a 9% increase over 2008’s $305.7...

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I think Impax has the right to manufacture generic OpanaER in all sizes starting January 1, 2013. I don't know if they will though with all of this crap from Endo. I don't know if they want to release a product that could be banned a few months later. Actavis had to fight tooth and nail just to be allowed to manufacture generic OpanaER in 7.5mg and 15mg. I wonder when Actavis will be allowed to make all sizes.

The preliminary FDA response seems like good news for those of us who want the generic....

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Sorry forget to add the news piece.

Endo Health Solutions Launches 7.5mg and 15mg strengths of Reformulated, Designed to be Crush-Resistant, OPANA ER


New strengths complete full line of offerings for OPANA ER with INTAC® technology designed to be crush-resistant

CHADDS FORD, Pa., Dec. 11, 2012 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that its subsidiary, Endo Pharmaceuticals Inc., has launched 7.5mg and 15mg strengths of its reformulated, designed to be crush-resistant, OPANA® ER (oxymorphone HCl) product. Now commercially available, the 7.5mg and 15mg options complete the launch of all approved strengths of the reformulated version of OPANA ER with INTAC® technology. The product is now available in seven dosage strengths: 5, 7.5, 10, 15, 20, 30 and 40mg.

"Considering that a substantial amount of abuse and misuse of opioid products is performed by manipulating the tablet through crushing and powdering, we are excited to offer patients and healthcare professionals a full line of strength options of the reformulated, designed to be crush-resistant, OPANA® ER," stated Julie McHugh, chief operating officer, Endo Health Solutions. "Now healthcare professionals and patients have seven strength options for extended release oxymorphone (HCl) in a version designed to be crush-resistant. We see this line completion as an important step forward for responsible pain management."

With the launch of 7.5mg and 15mg OPANA ER designed to be crush-resistant, Endo filed a false advertising suit against Actavis calling for the company to cease and desist promoting its non-crush-resistant extended release oxymorphone HCl product as A-B rated, or bio-equivalent, to the reformulated OPANA ER. The lawsuit was filed earlier today, Tuesday, December 11, 2012.

As Endo reported in November, surveillance data collected by national independent sources through the third quarter of 2012 suggest that the introduction of reformulated OPANA ER designed to be crush-resistant in February reduced abuse rates of the product when compared to the non-crush-resistant version that Endo discontinued in May. Additionally, rates of abuse for the non-crush-resistant 7.5mg and 15mg oxymorphone HCl tablets marketed by Actavis appear to have increased more than 122 percent since Endo launched its reformulated OPANA ER version.

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Just read Endo came out with the new Opana's in 7.5 & 15mg that the generic are already out. This is fine, the doctor knows if their patients may be abusing their meds. It should be up to them which to give them the new or old. Now if the FDA could see that they should approve generic old opana be approved of the 20mg and up and let the doctors decide makes more sense. Not fair to keep the generics from coming out in Jan. 2013.

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Endo didn't like losing money over their new abuse free Opana. Why can't the FDA see that? Like I have said, all the new rules doctors are required to jump through hoops in order to give their patients pain meds. If they are doing their jobs, there is a lot of control now on pain meds. Let the real chronic pain patients have the generic's. People need to sue the FDA if they hold up generic meds. If the FDA stops generic opana from being available, they will open a door for all of the other meds from being approved because the drug companies will wait till the last minute and stop their brand from being made into generic. This isn't about just one drug being approved for generic, it will affect all future generic meds.

The opioid painkiller is the Chadds Ford, Pennsylvania- based company’s second-biggest product. On Nov. 5, Endo fell the most in almost four years after quarterly sales declined for the first time since 2006 and the company ended a study of a bladder cancer drug.

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I just saw this today. People also need to tell the FDA that the new ones don't work as well. Endo, from everything I read and I have read a lot about this, they really are in it for the money. Of course they will not admit to this but why wait till the old was about to expire before bring out the new? Oxy had already came out with abuse free. You can't tell me the companies didn't know how to make their pain meds the same way until till the patent was ready to expire.


FTC: Brand Drug Redesigns Can Be Antitrust Violations
Drugmakers modifying their products exclusively to avoid generic competition are engaging in illegal exclusionary conduct, the FTC says.

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Endo will not listen. If Endo truly cared about patients, then they would not have released the new reformulated OpanaER. Many many pain patients have complained. Endo did not listen. That is why their sales and profits are down. The new reformulated OpanaER is causing them to lose millions of dollars.

That is why all of their press releases talk about increased profit in 2013. They are expecting to win the lawsuit. They want to use the law to create a monopoly on OpanaER. Why else would they sue the FDA? Why else would the just release reformulated OpanaER in 7.5 mg and 15 mg ( the current sizes of the generic ER version)?

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People who believe the old Opana worked better than the new should write to Endo telling them so. Please druggies stay away. We who have pain from bad accidents and cancer have been hurt enough by people who use it for fun. Doctors and health employees treat patients awful if they find out you are taking a strong pain medicine. FDA will be judging if the new works as well as the old. Everyone with health issues needs to contact FDA and Endo and tell them.the new doesn't work as well. The new doesn't give pain relief as soon and it doesn't last as long. If you don't voice your concern's now then say good bye to something that helped you be able to have a life. Go to work, spend time with your family, etc. because you will not feel good. The pain will keep you at home.

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Generic Opana approved but could change May 2013

FDA Rejects Endo’s Deadline On Opana ER Petition; Impax Product May Become New RLD

By Brenda Sandburg / “The Pink Sheet†DAILY Dec. 3, 2012
Word Count: 1199 / Article # 14121203008
Executive Summary

Endo files suit against FDA seeking preliminary injunction to require FDA to say whether Endo’s withdrawal of non-crush resistant Opana ER was for safety reasons; FDA contends it has until May 10, 2013 to make this decision.

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This states that If they have to name one opioid as “most dangerousâ€, then it would be methadone because of its relatively short duration of analgesic effect and long biological half life.
Which Opioid is the Worst Opioid?

by admin | Posted in: Clinical, Pharmacy and tagged Clinical, FDA, Opana, Opioid, pharmacy, Phil Walls, prescription drugs, Workers' Compensation

by Phil Walls, R.Ph., Chief Clinical and Compliance Officer

MSNBC recently published an article entitled “Rural America finds new killer in drug Opana®â€. The article indicates that “Opana is the hot new prescription drug of abuse, sometimes with tragic consequences.†It has been pointed out in numerous articles and presentations that deaths associated with prescription drug abuse now outnumber those from heroin and cocaine combined. This is all too true in rural America, and attention is being focused on Opana. Opana contains the ingredient oxymorphone. Opana ER replaced OxyContin® as the choice for abuse for one simple reason – Purdue Pharma, which manufactures OxyContin, released a re-formulated OxyContin last year which makes it more difficult to chew or crush than the original version. This re-formulation was a direct result of the FDA’s Risk Evaluation and Mitigation Strategy. Chewing or crushing is what enables the drug abuser to experience the euphoria associated with ingesting or injecting a high dose of an opioid. The good news, if there is any in an article of this nature, is that REMS also applies to Opana ER. As a result, the old version of Opana ER is no longer being produced as of late last year. In fact, the only Opana product available from the myMatrixx mail service pharmacy is the new version which is similar to the re-formulated OxyContin in that it is difficult to chew or crush. So what happens if both OxyContin and Opana ER have been re-formulated?

Several consequences may result: 1) the sales of Oxycontin and Opana ER should decrease if they no longer provide a convenient source of high dose opioid for intentional abuse, 2) the drug abuser may seek out heroin or other illicit substances, 2) the drug abuser may find alternatives to their prescription drug of choice, or 3) the drug abuser may find ways to bypass the new formulations of OxyContin or Opana ER. Unfortunately the internet has turned into a resource for drug abusers that fall into the latter category.

I heard Opana described as much more dangerous than OxyContin recently (largely I believe because of the article referenced by MSNBC), and that made me question whether or not one opioid may be more dangerous than another. In my opinion, here are my conclusions on this question:

All opioids are dangerous.

The euphoria created by opioids is dose dependent, which means that an addict may get “high†from an injection of heroin or from intentionally consuming large quantities of an over the counter opioid such as dextromethorphan. Yes, I just said over-the counter opioid.

It is true that one opioid may be more “potent†than another. However, dose (or the amount consumed which is dependent on access) is more important that potency when it comes to abuse.

The real danger in terms of side effects such as respiratory depression and death lies in drug characteristics other than potency. This includes the long biological half-life (the amount of time it takes for the body to eliminate half of the drug) of a drug like methadone, or the ability to by-pass a drug’s “extended-release†formulation. The latter has included crushing or chewing drugs like OxyContin or Opana ER (although the new formulations make this more difficult) or the intentional misuse of Duragesic® or fentanyl patches. The latter I have heard described as “fentanyl tea†in which the patch is “brewed†as in the making of a cup of tea. I am also aware of emergency room incidents in which the abuser has severe burns caused by the application of a hot iron to the patch in order to cause rapid release of the fentanyl.

With all that said, I repeat, all opioids are dangerous. I wish there was a simple solution where I could recommend that certain opioids should simply be blocked from your formulary. However, there are steps that can be taken to minimize risk:

Monitor early use of opioids through our ARM program,
Consider the use of step-therapy in the approval of opioids,
Adopt patient-provider agreements (aka, narcotics contracts) as policy for the use of any opioid,
Monitor the daily morphine equivalent dose through our myRisk Predictorâ„¢.

If I have to name one opioid as “most dangerousâ€, then it would be methadone because of its relatively short duration of analgesic effect and long biological half life. This combination makes it very easy for a patient or drug abuser to inadvertently suffer an overdose and possibly death.

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Read what Endo states what they think will happen with Opana in 2013-14.
*double-digit prescription growth in products like Voltaren Gel and the reformulated OPANA ER which will drive growth in our branded pharmaceutical businesses.
Endo Health Solutions' CEO Discusses Q3 2012 Results - Earnings Call Transcript
November 5, 2012 | about: ENDP

Looking ahead, new products, devices and services will be one key to our future success. Today our R&D pipeline is poised to deliver important new products beginning in 2013, including select launches of high-value generics during the next two years. Were investing in new medical devices and practice management services both on our own and in collaboration with other companies. You should begin to see the fruits of those labors starting in 2013 and 2014.

We have multiple opportunities for significant organic growth within our diversified businesses. And as I stated at last months analyst meeting, we expect to enhance our growth by continuing to invest in our current commercial portfolio, delivering an expanded value proposition with new products and services through our pipeline and through business development.

We expect Qualitest to deliver year-over-year double-digit sales growth through 2013. This will be supported by increasing our production capacity by 15% annually over the next year, three years to support its growth. We expect to see a return to double-digit prescription growth in products like Voltaren Gel and the reformulated OPANA ER which will drive growth in our branded pharmaceutical businesses.

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