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Seriously, what?????????????
It will not matter because taking both IR and ER opioids on an empty stomach makes any and all food issues a non-event.
You're missing an important link...
The best solution is:
"to take on an empty stomach one hr before a meal or two hrs after a meal"
Exactly what the FDA approved for the +60 Oxymorphone drugs including both IR and ER drugs.
I have posted this many times with links.
No "Food Specifics" are used.
I do not understand why this so hard.
Sprinkling on food due to patient's swallowing problem = okay
Sprinkling on food to resolve drug's kinetic problem= not okay
Very, very simple.
I guess that's one theory.
Applesauce specifically aids the absorption of certain foods after a "Fat meal" and exactly why the FDA Margaret Hamburg had approved the use for SequestoX in 2014/2015.
Califf's FDA did a 180 in Jul 2016 and rejected AppleSauce being a "Food Specific" solution
Huh?
Specific Food "Applesauce" violates Califf's rules .
Unrelated issues, and incorrect.
Sorry but you have missed the entire issue regarding Embeda and Troxyca approval.
"Food Specific" applesauce was used in the FDA Pamphlet for both ER Embeda and ER Troxyca capsules for some "mysterious swallowing" issue. No other opioid capsule has such a pamphlet instruction. The FDA CRL SequestOx because of a "Food Specific" solution.
Please provide a link to this other company being issued a second CRL in the same field as Elite.
The CRL focuses on the abuse-deterrent properties of REMOXY ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter.
Knight's Naked Shorts
If you own this stock or any penny stock, you need to read this whole series. Whether you believe in naked shorting or deny it exists, you need to read this whole series. And if you already despise the market maker "Knight Capital", or if you already think the SEC is painfully disinterested and feckless, then DO NOT READ THIS SERIES OR ELSE YOUR HEAD WILL EXPLODE.
Penny Stock Chronicles by David Dayen in The Intercept. Very interesting reading.
https://theintercept.com/series/penny-stock-chronicles/
Not here for that.
what positive points have you brought up?
What would it look like?
http://marketwire-yahoopartner.tumblr.com/post/144246839598/intellipharmaceuticals-internationals-cfo-domenic
DISCLOSURE:
Intellipharmaceuticals International Inc. paid Streetwise Reports to produce and distribute this interview. Domenic Della Penna had final approval of the content and is wholly responsible for the validity of the statements.
makes me really think we are on the verge of some big catalysts.
Why would the FDA give IPCI the ability to proceed without a phase III test if the concerns you raise are legit?
Why would they wave the application fee?
It seems pretty unreasonable to believe the FDA would lead the company down the path it has if the concerns you raise are so obvious.
The overwhelming need for something to help on the terrible opioid abuse front is certainly causing the FDA to prioritize such drugs. Do you really think Rexista has no value in deterring abuse? Really?
Has anyone else raised this concern about Rexista or is this your own pet beef? And if it is only you, doesn't that seem a bit odd? Given the seriousness of the issue (people dying is pretty serious), you would think you would not be the only person in the world to raise this concern.
Yes, I am saying that.
WeeZuhl, blue dye or color is inactive ingredient, so why are you arguing? Are you arguing blue dye is a medical active ingredient, so it needs safety testing?
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.
Sorry Man I was trying to save you.
why don't you give us a quick review of each situation and how it applies to IPCI? Aso, you avoided some of the other questions I asked.
And, if indeed they are aware of that risk, might they have determined that their was a greater risk from dying from an overdose than dying from the blue dye?
Why are you trying so hard? If you don't like the drug, contact the company and the FDA.
I doubt that.
A "pro wrestler" taking 65 extra strength Vicodin a day?!!!
So if what you say is true, why would the FDA allow this drug to get this far without deep sixing it already?
A lot of wrong.
The whole septic argument seems ridiculous. If you are septic you will be in the hospital. If you are going to die it will be from the bacterial infection not a blue dye. Also no doctor is going to prescribe this medication to alleviate the pain / fever caused by a septic infection. You will be fed by a nutrient IV and you wont be swallowing or drinking anything. Your pain med would probably be administered thru the IV and not a ADF. I'm NOT A DOCTOR but this seems pretty basic.
I'm not hinting it, I'm saying it.
your hinting like the blue stained inner lining will just "dose dump" toxic amounts of pre-stained lining when someone becomes septic. that doesn't happen.
Yes, yes, yes! No, no, no.
your illustrations do not account for the staining factor. this is not an insoluble molecule it will be staining the entire inner wall all along. even to the sides of the individual cells before it even gets to the blood system. now you have started with less than what is considered a safe amount ingested being further diluted by the fact it will never reach the circulatory system due its staining effect. so lets assume a person does have a perforated inner wall in the intestine.
fabius, you are correct
WZ,
just try to abandon - for a moment - your phisician perspective; and just look at the share price perspective.
Even assuming that there could be some issues coming out from the FDA with regards to the blue dye, from now to that moment you still have plenty of catalyst which could push IPCI share price very high.
So, unless the potential IPCI partner has your same assessment, I think you better invest some money in IPCI from now until Christmas.
Lucky for us...
There isn't 1 single person who even remotely believes/thinks the tiny amount of FDA approved blue dye levels in 2 pills of Rexista per day is going to turn anyone into blue smurfs and die as you've repetitively falsely alleged!
thanks for the question samsa
isnt that making an assumption the dye stays liquid and in the stomach? my thought is, it wont act as in your theroy. that was a direct liquid (dye)placed into an already at risk patient. allowing the dye to permeate. if a person takes the pill and it disolves naturally and releases the dye into the stomach. at that point the dye should just stain the stomach wall or duodenum. then if that becomes setic and permeates, there is no dye left to go itno the body it should already be absorbed staining the stomach and intestinal walls, correct? your assumption is the dye would stay a dye and liquid which had an immediate source of entry. so what am I missing?
QUESTION: Why add the blue dye?
Weez, no one claimed it was crush proof. It deter, not prevent.
QUESTION: Why add the blue dye?
But the Dye result should definitely reveal something to abusers trying to ignore the fact their nose and mouth have turned blue.
QUESTION: Why add the blue dye?
The dye will likely work much like track marks do on heroin users. Most heroin users go to great lengths to hide track marks. Many start to injecting between toes and other obscure areas to hide it. No real way to hide the dye s they may move on to other easier drugs to abuse.
Samsa I also appreciate your thoughtful responses
because blue dye was known to have an effect on people with certain aliments when a blue feeding tube was used on them
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.
James P. Maloney, M.D.
Medical College of Wisconsin, Milwaukee, WI 53226
Ann C. Halbower, M.D.
Brian F. Fouty, M.D.
Karen A. Fagan, M.D.
Vivek Balasubramaniam, M.D.
Adrian W. Pike, Ph.D.
Paul V. Fennessey, Ph.D.
University of Colorado, Denver, CO 80262
Marc Moss, M.D.
Emory University, Atlanta, GA 30322
ahasja, I appreciate your thoughtful responses
Our RexistaTM XR formulation contains a blue dye that is emitted once the tablet is tampered with or crushed. The blue dye will stain mucous membranes and skin if the product is manipulated and comes in contact with moisture. This stigmatizing blue dye is intended to act as a visible deterrent against inappropriate use if abused orally or via the intra-nasal route.
Okay, 1 vote for Rexista isn't crush-proof
WeeZuhl, if someone grinds the pill with a goal of snorting or chewing it, it releases a blue dye that stains the entry point. That's the reason.
looks like the Keystone Cops are at it again
hondobud you nailed it
What is the reason to add a dye?
Sometimes one doctor can make all the difference...
Did you know that the process to change hydrocodone from Schedule 3 to Schedule 2 was started based on a letter from one doctor?
Did you see that one doctor blew the whistle on Flint lead crisis, despite being repeatedly told she was wrong, with many accusing her of having nefarious motives?
http://www.freep.com/story/news/local/michigan/2015/10/10/hanna-attisha-profile/73600120/
But then Hanna-Attisha, a pediatrician for many of Flint’s poorest families whose training and experience has focused on environmental toxins and health disparities, shook her head.
“But then I’m tearful because how could this have happened in 2015 when all these regulations are in place (to ensure clean water)? For a population that has every burden in the world already, this is the last thing they needed,” she said.
In retrospect, Hanna-Attisha served as the canary in the coal mine in this latest public health crisis — the doctor who spotted a problem and wouldn’t let it go until others paid attention, said Dr. Eden Wells, the state’s chief medical executive.
“She was a doc on the front lines who knows to pick up the phone ... rattle some cages and say ‘Hey, come here, we’ve got a problem,’ ” Wells said.
FDA encourages participation from all public stakeholders in its decision-making processes. Every advisory committee meeting includes an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing (21 CFR 14.25(a)).
Still waiting for that link....
Anybody find any previous examples of blue dye used for "stigmatizing" a drug abuser?
FIRST TIME EVER = NEW USE
http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/
Petition Review Process
When evaluating the safety of a new color additive or a new use for a listed color additive, FDA considers such factors as probable consumption or exposure from its use, cumulative effect in the diet, evaluation by experts qualified by scientific training and experience, and the availability of analytical methods for determining its purity and acceptable levels of impurities.
Any interested person may petition FDA for the use of a new color additive or to amend the listing of a color additive for a new use. The petitioner for a new color additive must provide information on the following:
•Identity of the proposed color additive
•Physical, chemical, and biological properties
•Chemical specifications
•Manufacturing process description
•Stability data
•Intended uses and restrictions
•Labeling
•Tolerances and limitations
•Analytical methods for enforcing chemical specifications
•Analytical methods for determination of the color additive in products
•Identification and determination of any substance formed in or on products because of the use of the color additive
•Safety studies
•Estimate of probable exposure
•Proposed regulation
•Proposed exemption from batch certification
•An environmental assessment or claim for categorical exclusion
The petitioner must submit data demonstrating the safety and suitability of the new color additive or new use. FDA will then evaluate the data in the petition, public comments to the petition, and other relevant data in FDA's files.
Upon approval of the petition, FDA will issue a new listing regulation or alter an existing regulation for the new color additive or new use. The process for submitting petitions is described in detail in 21 CFR parts 70 and 71, which describe the format, the administrative requirements, and the information and data required. The data that are appropriate for support of a color additive petition will vary depending on whether the petition is for a new color additive or for a new use for a listed color additive, the level and type of use of the proposed color additive, and the amount of color additive and its impurities that may enter body tissues. The petition process also is described on the agency's Web site.
There you have it...
Answered that The blue dye is GRAS and they do not comment publicly on their formula for obvious reasons.
Generally recognized as safe (GRAS) is an American Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.
I can tell you're trying...
the FDA didnt reject the other drug because it created the side effect of flushing but saying by eating food it took away the desired effect therefore it was no longer a deterrent. so to do an accurate comparison, IPCI wants to turn lips or fingers blue if you crush the pill as a deterrent. as long as eating food doesn't take away that effect it still works.
Details of the Complete Response Letter (CRL)
In addition, we had proposed in the REMOXY NDA a label claim against abuse by chewing. Our proposal was based on clinical results of an oral human abuse potential study that met all four co-primary endpoints with statistical significance and that also met several, but not all, secondary endpoints. The CRL asks us to submit a revised proposed label to indicate results of this study do not support a label claim against abuse by chewing.
I apologize for assuming facts not in evidence...
No the link says nothing about legitimate users. The link says it doesn't work as stated because eating cancels out the effect.
Last year an FDA advisory committee gave a thumbs-down to a version that also contained niacin as a means of preventing oral abuse.
Niacin, which can induce a chemical flush, was added as an extra disincentive, but critics said the flushing, could be easily defeated by taking an aspirin or even just food with the drug. Also there was concern that niacin could cause flush even among people who took the medicine as directed.
You're right, it is different.
So basically as long as someone ate food with the pills it didn't work. Its not exactly the same as the blue dye you keep bringing up.
Searching the patent shows its FD&C Blue #1 Aluminum Lake - Which is approved for use in drugs. So a little different I'd say
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.
James P. Maloney, M.D.
Medical College of Wisconsin, Milwaukee, WI 53226
Ann C. Halbower, M.D.
Brian F. Fouty, M.D.
Karen A. Fagan, M.D.
Vivek Balasubramaniam, M.D.
Adrian W. Pike, Ph.D.
Paul V. Fennessey, Ph.D.
University of Colorado, Denver, CO 80262
Marc Moss, M.D.
Emory University, Atlanta, GA 30322
Rexista’s Blue Dye Will Never Get Past AdComm
No Advantage + Possible Side Effects --> Hindenburg
http://www.fiercebiotech.com/biotech/19-1-vote-fda-panel-rejects-acurox
In 19-1 vote, FDA panel rejects Acurox
“What I'm hearing from the committee is that it's probably not appropriate to put the niacin in this product because it does not have a definitive advantage, and it has associated side effects," said Jeffrey Kirsch, chairman of the Anesthetic and Life Support Drugs Advisory Committee, which voted on the drug.
PTIE's Remoxy CRL was all about ADF label.
Man, those guys really know how to PR a CRL. Practice makes perfect. As I previously predicted, no new NDA approval without ADF label. More important, it turns out Pfizer was correct to give back Remoxy to Pain & Durect in order to focus on Embeda and ALO-2. Pfizer knows that the antagonist ADF technology just plain works better. ELTP 2 bead antagonist ADF is best yet. Unlike Pfizer's anatagonist ADF, ELTP 2 bead ADF is modular across the entire spectrum of opioid agonists and time-release characteristics.
https://globenewswire.com/news-release/2016/09/26/874482/0/en/Complete-Response-Letter-for-REMOXY.html
The CRL focuses on the abuse-deterrent properties of REMOXY ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter.
Pain Therapeutics is evaluating the CRL and plan further discussions with the FDA. The CRL specifies additional actions that are needed in order to obtain approval of REMOXY ER with label claims against three routes of abuse (i.e., injection, inhalation and snorting). These actions may take approximately a year to conduct and may cost approximately $5MM, pending discussions with the FDA and outside clinical/regulatory consultants.
Details of the Complete Response Letter (CRL)
The CRL focuses on the actions and studies that are needed in order to obtain approval of REMOXY ER with label claims on three routes of abuse (i.e., injection, inhalation and snorting). In conducting the following studies, we will generally compare REMOXY ER vs. one or more commercially available oxycodone ER drug product:
To support a potential drug label claim against abuse by injection: Repeat an injectability/syringeability study using thin films of drug, smaller volumes of solvents, additional mixed solvents and alternative extraction methods and syringe filter.
To support a potential drug label claim against abuse by inhalation: Repeat a volatilization study using the same thickness for each drug to increase surface area.
To support a potential drug label claim against abuse by snorting: Conduct an intranasal abuse potential study in human volunteers (i.e., not the animal data we had submitted) with drug applied directly inside the human nasal cavity.
In addition, we had proposed in the REMOXY NDA a label claim against abuse by chewing. Our proposal was based on clinical results of an oral human abuse potential study that met all four co-primary endpoints with statistical significance and that also met several, but not all, secondary endpoints. The CRL asks us to submit a revised proposed label to indicate results of this study do not support a label claim against abuse by chewing.
lol @ "smurfs"