FDA accepts application for fentanyl sublingual spray

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Insys Therapeutics, a developer of pharmaceutical products, has received the US Food and Drug Administration's (FDA) acceptance for Fentanyl SL Spray new drug application (NDA).

Insys uses proprietary technologies for the development of product candidates that address the clinical shortcomings of existing commercial products.

Insys CEO Michael Babich said they are excited to have the FDA accept their filing, and they look forward to building a commercial infrastructure to launch this product for patients suffering from breakthrough cancer pain.

"The proprietary sublingual delivery system will provide us an opportunity to deliver pain relief to cancer patients who suffer from excruciating acute pain episodes that overcome the analgesia of chronic opioid medications," Babich said.
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source @ http://drugdelivery.pharmaceutical-...da-accepts-insys-fentanyl-sl-spray-nda-120511
 
I'm assuming you can snort that as well.

Why is fentanyl such a big target for the pharmaceutical industry? And all they do is just change the roa. Duragesic, Instanyl, Actiq, Fentora, etc. Never mind, I guess it's just the ease of creating them and profit.
 
^I'd have to agree. I feel like fentanyl is the most potent opioid they can use with any margin of safety...so they're milking that one as much as they can.
 
/Rant on:

phrozen said:
Why is fentanyl such a big target for the pharmaceutical industry? And all they do is just change the roa. Duragesic, Instanyl, Actiq, Fentora, etc. Never mind, I guess it's just the ease of creating them and profit.
Click to expand...
^This. It seems like there's a trend in the pharmaceutical industry to take an existing product that the patent has/is about to expire, make a minor tweak (e.g. such as making it XR, isolating the active isomer, changing the method of administration or adding another active ingredient etc.), and patent it as a new name brand drug. Thus, there can be no generic equivalent or competition, and they can charge a ridiculous amount for it.

This practice seems like a blatant ploy to increase profits to me, but I don't even fault the pharmaceutical industry here. Corporations exist solely to make money, and this is an easy way to do so. That's why in theory it's up to the government to regulate business. The FDA shouldn't just rubber stamp this price gouging crap. But, what do you expect when the regulatory agency has practically been handed over to the industry it's supposed to police? I think the FDA should make drug makers show that their product is actually an improvement over existing options in order to be granted approval (there could be an exception to this if they don't make their product proprietary, and generics are immediately available).

Also, doctors have some of the blame here too. It seems as if they just blindly switch over to the "latest and greatest" pill merely because some pharm rep gave them some new pens and a trip to the Bahamas. Doctors supposedly have a great understanding of what drug to use and why when treating an illness. for example, how can they justify using patented eszopiclone instead of generic zopiclone when they know it's no different? They should be more cognizant of the harm they are causing society by stoking rampant inflation in the medical field. Rising health care costs are putting our government on a financially unsustainable path, and medical costs are a real hardshipin many people's lives. This disregard for cost does not help, and it hurts the credibility of their profession IMO.

/Rant off.
 
I'd love to get my hands on some of this stuff. I wonder if there will be any kind of anti abuse method for this preparation. I think it would be pretty easy to IV this stuff. Hope I get my hands on it, but of course around where I live it's pretty hard to get fent, everybody wants their oxycodone. I really don't get it, I've seen some people dope sick as hell off oxy, and they won't ake anything else. Some people are so ignorant.
 
stirfry said:
/Rant on:

^This. It seems like there's a trend in the pharmaceutical industry to take an existing product that the patent has/is about to expire, make a minor tweak (e.g. such as making it XR, isolating the active isomer, changing the method of administration or adding another active ingredient etc.), and patent it as a new name brand drug. Thus, there can be no generic equivalent or competition, and they can charge a ridiculous amount for it.

This practice seems like a blatant ploy to increase profits to me, but I don't even fault the pharmaceutical industry here. Corporations exist solely to make money, and this is an easy way to do so. That's why in theory it's up to the government to regulate business. The FDA shouldn't just rubber stamp this price gouging crap. But, what do you expect when the regulatory agency has practically been handed over to the industry it's supposed to police? I think the FDA should make drug makers show that their product is actually an improvement over existing options in order to be granted approval (there could be an exception to this if they don't make their product proprietary, and generics are immediately available).
/Rant off.
Click to expand...

Yes, the trend to slightly modify existing medicines or their methods of administration is definitely on. But it has been for quite some time really, we are just getting much better at it now. After all, morphine can be extracted from opium, heroin is just a slight modification of morphine, and the hypodermic needle just another route of administration. Combining different drugs is basically the same.

The question for drug companies is this: where do you start looking for new chemical preparations to bring to market? Generally speaking, they look at existing chemical preparations, or other chemical preparations that there is some scientific basis for believing it will have the desired therapeutic effect without intolerable side effects. This common starting point is why we have classes of closely related drugs like all the families of antibiotics, so many benzos and routes of administration, anti-inflammatories that are chemically similar, etc.

As far as the varying routes of administration or other tweaks go, some drug companies specialize in just making a new delivery devices and delivering just about any drug possible with it (Alexza is doing trials with inhalable fentanyl and has inhalable alprazolam and nicotine products in the works). There are fewer barriers to getting small tweaks to existing drugs approved by the FDA than something totally new and alien.

I'm not one to defend the FDA, but they do have an approval process that must be followed. First the drug companies run clinical trials of their therapy and report on these trials to the FDA. Once they have convinced the FDA that these trials have completed successfully they can file a new drug application (NDA).

The FDA will reply to this NDA with either a date for approval to be completed by (a Prescription Drug User Fee Act (PDUFA) date) or a Complete Response Letter (CRL). PDUFA date = drug may be approved soon, CRL = Go to jail. Go directly to jail. Do not pass go, do not collect $200 ;) But just like Monopoly the company can reply to the CRL and try and get a PDUFA date.

The drug company will prepare for the PDUFA date with a business plan that assumes approval while their fate hangs in the balance, or addresses the issues the FDA brought up in any meetings or other correspondence. The FDA can basically ask anything of the drug company or delay approval, demand more clinical trials or other data, or otherwise make marketing this new chemical preparation difficult at any point in time.

It definitely seems like some drug companies are much better than others in working with the FDA to get past any problems and get approval for their new drug or medical device. Is there collusion? Possibly. Or maybe some companies are just better at working with the FDA than others due to having more or better resources for communicating with the FDA and thoroughly replying to the FDA's questions and otherwise addressing the FDA's concerns.

When a PDUFA date arrives the FDA has to approve the chemical preparation, or can issue a CRL and demand more (clinical trials, data, research, changes, etc) from the drug company before the FDA will approve it. This can go on for many, many years and costs drug companies lots of money all along the way. Lots of small drug companies basically blow up when their drug gets a CRL instead of approval, not that it's a bad thing. But this is how the process works in a nutshell. Lots of drugs don't ever get approved. I can talk details if you want, I am into speculative biotech stocks and have made and lost lots of money on drug approvals and CRLs. How much influence a drug company has on the FDA is debatable.

The way intellectual property work now in the USA is total crap. But I'd recommend taking a closer look at what happens with the FDA nowadays, at least half of all drugs that even get PDUFA dates get rejected.
 
TearItDown said:
And yet, marijuana is still illegal.
Click to expand...

My thoughts exactly. And a nice big fuck you to the FDA, DEA, FBI etc. Oh and an oversized FUCK YOU to Michael Babich, you cocksmoking capitalist whore, youre the biggest, most worthless piece of shit there is. Go suck on a couple of your brandy new gel patches, cunt. :D
 
thinctwo said:
Yes, the trend to slightly modify existing medicines or their methods of administration is definitely on. But it has been for quite some time really, we are just getting much better at it now. After all, morphine can be extracted from opium, heroin is just a slight modification of morphine, and the hypodermic needle just another route of administration. Combining different drugs is basically the same.

The question for drug companies is this: where do you start looking for new chemical preparations to bring to market? Generally speaking, they look at existing chemical preparations, or other chemical preparations that there is some scientific basis for believing it will have the desired therapeutic effect without intolerable side effects. This common starting point is why we have classes of closely related drugs like all the families of antibiotics, so many benzos and routes of administration, anti-inflammatories that are chemically similar, etc.

As far as the varying routes of administration or other tweaks go, some drug companies specialize in just making a new delivery devices and delivering just about any drug possible with it (Alexza is doing trials with inhalable fentanyl and has inhalable alprazolam and nicotine products in the works). There are fewer barriers to getting small tweaks to existing drugs approved by the FDA than something totally new and alien.

I'm not one to defend the FDA, but they do have an approval process that must be followed. First the drug companies run clinical trials of their therapy and report on these trials to the FDA. Once they have convinced the FDA that these trials have completed successfully they can file a new drug application (NDA).

The FDA will reply to this NDA with either a date for approval to be completed by (a Prescription Drug User Fee Act (PDUFA) date) or a Complete Response Letter (CRL). PDUFA date = drug may be approved soon, CRL = Go to jail. Go directly to jail. Do not pass go, do not collect $200 ;) But just like Monopoly the company can reply to the CRL and try and get a PDUFA date.

The drug company will prepare for the PDUFA date with a business plan that assumes approval while their fate hangs in the balance, or addresses the issues the FDA brought up in any meetings or other correspondence. The FDA can basically ask anything of the drug company or delay approval, demand more clinical trials or other data, or otherwise make marketing this new chemical preparation difficult at any point in time.

It definitely seems like some drug companies are much better than others in working with the FDA to get past any problems and get approval for their new drug or medical device. Is there collusion? Possibly. Or maybe some companies are just better at working with the FDA than others due to having more or better resources for communicating with the FDA and thoroughly replying to the FDA's questions and otherwise addressing the FDA's concerns.

When a PDUFA date arrives the FDA has to approve the chemical preparation, or can issue a CRL and demand more (clinical trials, data, research, changes, etc) from the drug company before the FDA will approve it. This can go on for many, many years and costs drug companies lots of money all along the way. Lots of small drug companies basically blow up when their drug gets a CRL instead of approval, not that it's a bad thing. But this is how the process works in a nutshell. Lots of drugs don't ever get approved. I can talk details if you want, I am into speculative biotech stocks and have made and lost lots of money on drug approvals and CRLs. How much influence a drug company has on the FDA is debatable.

The way intellectual property work now in the USA is total crap. But I'd recommend taking a closer look at what happens with the FDA nowadays, at least half of all drugs that even get PDUFA dates get rejected.
Click to expand...
Just wanted to say thanks for posting that. :)
 
None of you guys will ever see this stuff. It will only be used in hospitals for terminally ill patients.
 
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