Anonymous ID: 257256 March 21, 2018, 5:11 p.m. No.749100   🗄️.is 🔗kun   >>9106

Following sauce leads to evidence that FDA may be protecting Teva's and Schumer's market of oxycondone and in doing so, leading to ongoing abuse and death of thousands of Americans a year.

 

 

Teva and Chuck Schumer' association from Previous Bread found here:

 

https:// 8ch.net/qresearch/res/720188.html#720721

https:// 8ch.net/qresearch/res/717120.html#718464

https:// 8ch.net/qresearch/res/720188.html#720330

 

It should be recognized that the FDA under President Obama's administration has gained an extensive back log of medications being approved and the average time of approval climbed significantly. Sauce in Senator Cotton's following letter. Was this a purposeful way of providing protection for already approved medications?

 

http:// www.cotton.senate.gov/files/documents/FDALetter.pdf

 

If one has been following the NDA's and ANDA's of smaller drug companies trying to get into the market, the increasing back log of medications seeking approval has been very obvious.

 

One such company I followed that was trying to break into the market to target and prevent oxycodone addiction is Intellipharmaceutics with a drug they labeled Rexista.

 

How does it function? See here:

 

"Our RexistaTM (abuse deterrent oxycodone hydrochloride extended release tablets) NDA product candidate is intended as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. The RexistaTM long-acting formulation of oxycodone is intended to present a significant barrier to tampering when subjected to various forms of physical and chemical manipulation, and is designed to make the product unlikable and discourage or make it more difficult to manipulate for the purpose of abuse or misuse. It is also designed to prevent dose dumping when inadvertently co-administered with alcohol. Dose dumping is the rapid release of an active ingredient from a controlled-release drug into the blood stream that can result in increased toxicity, side effects, and a loss of efficacy. Dose dumping can result by consuming the drug through crushing, taking with alcohol, extracting with other beverages, vaporizing or injecting. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting and snorting. Our RexistaTM formulation is difficult to abuse through the application of heat or an open flame, making it difficult to inhale the active ingredient from burning. If approved, RexistaTM may be the only abuse-deterrent oxycodone product with properties that may provide early warning of drug abuse if the product is manipulated or abused. The formulation contains a blue dye that is emitted once the tablet is tampered with or crushed, and may act as a deterrent to a user who attempts to abuse it orally or via the intra-nasal route. The Company previously announced the results of a food effect study which showed that RexistaTM can be administered with or without a meal (i.e., no food effect), providing another point of differentiation from currently marketed oral oxycodone extended release products."

 

Teva (Schumer) is a competitor of IPCI's (Intellipharmaceutics) Rexista as noted here:

 

"Teva (NYSE: TEVA), one of the behemoths, big, big player in the generics space and the new drug space. They are competitors from the point of view or the fact that they are working in the abuse deterrent area as well,"

Oxycodone does approximately "$2.5 to $3 billion dollar sales in the US"

 

IPCI has created "Rexista" they are trying to get approved by FDA, Rexista is an opiod PROVEN to be equivalent as effect as generic oxycodone but has properties to also prevent abuse:

 

https:// investingnews.com/daily/life-science-investing/pharmaceutical-investing/intellipharmaceuticals-abuse-deterrent-technologies/

 

part 1

Anonymous ID: 257256 March 21, 2018, 5:11 p.m. No.749106   🗄️.is 🔗kun

>>749100

 

Part 2

 

And advisory committee was tasked with evaluating Rexista to see if it could be fast tracked through the FDA. The outcome was as follows:

 

"The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 22 to 1 in finding that the Company’s New Drug Application (“NDA”) for Rexista™ abuse-deterrent oxycodone hydrochloride extended release tablets should not be approved at this time. The committees also voted 19 to 4 that the Company has not demonstrated that Rexista™ has properties that can be expected to deter abuse by the intravenous route of administration and 23 to 0 that there are not sufficient data for Rexista™ to support inclusion of language regarding abuse-deterrent properties in the product label for the intravenous route of administration."

 

https:// globenewswire.com/news-release/2017/07/27/1063131/0/en/Intellipharmaceutics-Provides-Update-on-FDA-Advisory-Committees-Meeting-for-Rexista-oxycodone-hydrochloride-extended-release-an-Abuse-Deterrent-Opioid-Analgesic-for-the-Treatment-o.html

 

What doesn't fit with this narrative that there is no evidence of positive effect, is a) you can't inject intavenously a medication that has formed a gel when crushed or heated, and b) the following:

 

"At the 30th US Psychiatric and Mental Health Congress Thomas Kosten, MD, a psychiatrist with Baylor College of Medicine, explained that there is evidence that tamper-resistant and abuse-resistant formulations of opioids decrease the abuse of that specific drug, but that payers aren’t as willing to cover these formulations because they cost substantially more."

https:// youtu.be/en09tNvVDDA?t=110

 

Even more surprising, another competitor Endo Pharmaceuticals was asked to remove it's extended release oxymorphone.

 

"And this summer, the agency made an unusual move and asked Endo Pharmaceuticals Inc. to take its extended release oxymorphone, Opana ER, off the market — a request the company later complied with."

 

https:// www.biopharmadive.com/news/intellipharmaceutics-fda-rejection-rexista-crl/505744/

 

Which would lead one to believe doing so gave Teva a larger share of the oxycodone market.

Anonymous ID: 257256 March 21, 2018, 5:39 p.m. No.749321   🗄️.is 🔗kun

>>749203

 

My post on Sean Penn's association with multiple bad acting countries at significant times and with top end officials (Chaves, Castro, King pin- El Chapo, Iraq's top minister, etc..) was lost off of notables… maybe it wasn't enough?

 

But I question if it wasn't malicious.