Immediate Release OXY being REFORMULATED

http://www.biospace.com/news_story.aspx...

"Based on our recent pre-NDA communications with the FDA, we intend to submit a new drug application for POSIDUR in late 2012 or early 2013," stated James E. Brown, D.V.M., President and CEO of DURECT. "We are also pleased that Pfizer continues to move forward with their efforts to prepare for an FDA interaction later this year with respect to REMOXY and that Zogenix has commenced a Phase I clinical trial for Relday."

Update of Programs:

•REMOXY®(oxycodone) Extended-Release Capsules CII. Pfizer has efforts underway to resolve the issues raised in the REMOXY Complete Response Letter and stated in their earnings call on July 31, 2012 that they are analyzing preliminary results from two bioavailability studies and hoping to meet with the FDA in the fourth quarter. The issues raised in the Complete Response Letter relate primarily to manufacturing.

REMOXY,an investigational drug, is a unique long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT's ORADUR® technology, which is covered by issued patents and pending patent applications owned by us, REMOXY is designed to discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.

http://www.medpagetoday.com/ProductAlert/Pres...

The FDA has approved a short-acting opioid painkiller with abuse-deterrent properties, the drugmaker Pfizer announced Monday.

Oxecta, a new formulation of oxycodone, had previously been under development as Acurox, which included niacin to deter oral abuse. That version received a thumbs down from an FDA advisory panel in 2009.

The new drug uses "Aversion" technology, licensed from Acura Pharmaceuticals -- which is described as a "unique composition of commonly used pharmaceutical ingredients" -- to stop potential abusers from crushing, chewing, snorting, or injecting the opioid. It does not deter oral abuse.

But Pfizer noted in a statement that the potential to abuse the drug via these routes still exists and "there is no evidence that Oxecta has a reduced abuse liability compared to immediate-release oxycodone."

In an earlier interview, Gail Cawkwell, MD, vice president of medical affairs at Pfizer, told MedPage Today that the technology causes the drug to "break down into crumbled chunks instead of powder if crushed, and turns it "sudsy" if it is mixed with liquid and drawn into a syringe"

ITS GOING TO HAPPEN THE SAME WAY THAT PURDUE REPLACED THE "OC" WITH THE "OP". WE WILL BE GETTING THE NEW FORMULA AND NOT EVEN KNOW IT UNTIL .... BAM!!! SO IF YOU PRICK OR SNIFF THESE MEDS JUST A "HEADS UP" Y'ALL. CAUSE ITS GOING TO BURN LIKE A 'SUMBICH'...

FDA Okays New Abuse-Resistant Opioid
By Kristina Fiore, Staff Writer, MedPage Today
Published: June 20, 2011
The FDA has approved a short-acting opioid painkiller with abuse-deterrent properties, the drugmaker Pfizer announced Monday.

Oxecta, a new formulation of oxycodone, had previously been under development as Acurox, which included niacin to deter oral abuse. That version received a thumbs down from an FDA advisory panel in 2009.

The new drug uses "Aversion" technology, licensed from Acura Pharmaceuticals -- which is described as a "unique composition of commonly used pharmaceutical ingredients" -- to stop potential abusers from crushing, chewing, snorting, or injecting the opioid. It does not deter oral abuse.

But Pfizer noted in a statement that the potential to abuse the drug via these routes still exists and "there is no evidence that Oxecta has a reduced abuse liability compared to immediate-release oxycodone."

In an earlier interview, Gail Cawkwell, MD, vice president of medical affairs at Pfizer, told MedPage Today that the technology causes the drug to break down into crumbled chunks instead of powder if crushed, and turns it "sudsy" if it is mixed with liquid and drawn into a syringe.

Oxecta is indicated for acute and chronic moderate-to-severe pain and is contraindicated in patients with respiratory depression, paralytic ileus, bronchial asthma or hypercarbia, and in those with a hypersensitivity to the opioid.

Among the most common adverse reactions are nausea, constipation, vomiting, headache, itchiness, trouble sleeping, and dizziness, according to Pfizer.

The new formulation joins a handful of other abuse-deterrent opioids that are on the market or in development. Purdue Pharmaceuticals, maker of long-acting oxycodone (OxyContin), had a tamper-proof version of its drug approved last year.

Making drugs harder to abuse has been one key strategy for some companies in an attempt to control what the government has deemed an epidemic of prescription painkiller abuse.

Pfizer acquired Oxecta when it merged with King Pharmaceuticals last year, along with an abuse-deterrent formulation of long-acting oxycodone (Remoxy) which is up for FDA approval on June 23.

gay

I take my meds orally but I'm still never thrilled when they start adding stuff. Part of my disease affects my stomach and I never know how it will react to things. I don't need to be more nauseous.

CabbagePatchGirl wrote:

I take my meds orally but I'm still never thrilled when they start adding stuff. Part of my disease affects my stomach and I never know how it will react to things. I don't need to be more nauseous.

I hear you Patch! Can we get an AMEN. I had to switch everything around because of the OC/OP thing with Purdue. I too take my meds orally. But for those who don't and take it in the vein or the nose ... well they are going to be in for a RUDE and PAINFUL experience at some point.

PRNbasis wrote:

<quoted text>
I hear you Patch! Can we get an AMEN. I had to switch everything around because of the OC/OP thing with Purdue. I too take my meds orally. But for those who don't and take it in the vein or the nose ... well they are going to be in for a RUDE and PAINFUL experience at some point.

The people that snorted Opana had a rude and painful awakening because of the bioavailability issue. 10% oral vs 50% in the shnaz!! Now from what I understand, oxycodone has a higher BA orally than insufflated. So I think the sniffers will have a hard time with their addiction to the actual process of snorting, but the IV users are definitely F'd! You can only go down from 100% to 80ish!
I do feel for the people with stomach issues though. Good
luck all...

CPspine wrote:

<quoted text>
The people that snorted Opana had a rude and painful awakening because of the bioavailability issue. 10% oral vs 50% in the shnaz!! Now from what I understand, oxycodone has a higher BA orally than insufflated. So I think the sniffers will have a hard time with their addiction to the actual process of snorting, but the IV users are definitely F'd! You can only go down from 100% to 80ish!
I do feel for the people with stomach issues though. Good
luck all...

I cringe to think of how many will end up on heroin. When OC made its change over to OP there was a 37% drop in OxyContin scripts but rehabs and whatnot reported 47% increase in heroin use . Go figure. I pray pray pray it doesnt affect the efficacy. I had to switch to IR when OP came out. Now my tolerance is thru the roof.

I just need to say that i had been on methadone for over 8 years and yes im off of it as of last friday, and the switch from that to the reformulated oxycontin at 20mg is just fine and im taking it the way a person should. So people out there please stop doing stupid things with it and dont mess with people who have to take it for real pain...