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port rhombus
01-28-2011, 03:34 PM
I'm going to try to share info like this on both sites, but I probably don't have the time or energy to do so for long. I'm sad.

Anyway...

As you may know, Endo recently submitted a new crush-resistant Opana ER formulation (think: OP) for FDA review. Well, it looks like the FDA bought us some extra time before we [presumably] need to develop a new extraction technique.

From http://www.bloomberg.com/news/2011-0...ed-by-fda.html:

Endo Pharmaceuticals Holdings Inc. said U.S. regulators rejected a formulation of its painkiller Opana ER designed to prevent tampering and abuse.

No additional clinical studies are required and the Chadds Ford, Pennsylvania-based company has begun discussions with the Food and Drug Administration over its decision about the crush- resistant drug, Endo said today in a statement.

Makers of 24 extended-release pain pills were ordered by the FDA in February 2009 to help devise a plan to minimize the risks of the products while ensuring patients kept access to the medicines. Opana and Opana ER, the extended release version of the medication, generated $230.6 million in 2009 sales for Endo, about 16 percent of its revenue, according to data compiled by Bloomberg.

Endo expects to satisfy the FDA’s concerns and file its application by mid-2011 for the drug’s approval, Ivan Gergel, Endo’s executive vice president for research and development, said in the company’s statement. “We remain focused on bringing this new formulation of Opana ER to market for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”

Endo fell 73 cents, or 2 percent, to $35.11 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares gained 70 percent in the past 12 months.

hopefiend
01-28-2011, 04:20 PM
this was what i was worried about when the op's came out now every cII med here in the stated is gonna go the same route.

I also wonder what the reason for the rejection was? Mabye something that will make them reevaluate the OP's?

Thanat0s
01-28-2011, 05:26 PM
was this just an effort to extend patent protection???

i havent seen a thing in the media regarding the reappearance of 'the blues...'

why the impetus for change when the abuse liability has been so low?

or is there something weve been sheilded from by interested parties?

normus420
01-28-2011, 05:34 PM
was this just an effort to extend patent protection???

i havent seen a thing in the media regarding the reappearance of 'the blues...'

why the impetus for change when the abuse liability has been so low?

or is there something weve been sheilded from by interested parties?

hmm I wonder... Ive heard rumers of this new formula but nothing 100%. I think endo's doing it to extend the patent. Saying there anti abuse is just an excuse imo to make more money and keep the fda happy. What are blues by the way?

Thanat0s
01-28-2011, 05:37 PM
blues were the mythical opiate of 'drugstore cowboy...'
numorphan, which was oxymorphone, taken off the market in the mid 70s
only to return as opana.

ka11ink
01-28-2011, 05:42 PM
blues were the mythical opiate of 'drugstore cowboy...'
numorphan, which was oxymorphone, taken off the market in the mid 70s
only to return as opana.

Ahh I never realized that; saw the movie but was never sure what they were referring to. Figured it was morphine or hydromorphone.

normus420
01-28-2011, 05:47 PM
yea I was thinking numorphan but wasent sure Ive heard xannies and roxi 30's called blue's to.