(Businessweek.com) Alexza Pharma licenses e-cig like smoking cessation product
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From the other thread:
Down side I see is the "lockout" safety feature. Would take away the user prescribed dosage of our e-cigs. If that thing passes, we may lose our rights to "self medicate", and a doctor would tell us how much nicotine we can envibe. Major downside.
Down side I see is the "lockout" safety feature. Would take away the user prescribed dosage of our e-cigs. If that thing passes, we may lose our rights to "self medicate", and a doctor would tell us how much nicotine we can envibe. Major downside.
You knew this was eventually coming. And if this particular design doesn't fly or make it through clinical trials, another pharma/biotech company will come up with one that will.
The e-cig market has been wide open for something like this in the USA for 2 - 3 years now. Any current e-cig manufacturer with enough confidence, clinically, in their product could have done this. Even if they didn't "have" the money up-front, enough confidence and proper business strategy could have gotten them the needed venture capital.
The really bad thing about this for the current e-cig industry IMO is that, regardless if the eventually approved product matches up to e-cigs in vaper's eyes; it will give the FDA an APPROVED e-cig like entity with which to go to battle. They can then easily enforce an immediate ban on any UNAPPROVED e-cig design. If I was an e-cig manufacturer/supplier I would be looking , immediately, to counter this by getting my product up to speed and beating the Pharma competition to the punch via my own clinical trial. Otherwise, the game , as they say, may be up.
The e-cig market has been wide open for something like this in the USA for 2 - 3 years now. Any current e-cig manufacturer with enough confidence, clinically, in their product could have done this. Even if they didn't "have" the money up-front, enough confidence and proper business strategy could have gotten them the needed venture capital.
The really bad thing about this for the current e-cig industry IMO is that, regardless if the eventually approved product matches up to e-cigs in vaper's eyes; it will give the FDA an APPROVED e-cig like entity with which to go to battle. They can then easily enforce an immediate ban on any UNAPPROVED e-cig design. If I was an e-cig manufacturer/supplier I would be looking , immediately, to counter this by getting my product up to speed and beating the Pharma competition to the punch via my own clinical trial. Otherwise, the game , as they say, may be up.
Not really. If they decide to ONLY allow that device, then it would be up to the doctor to provide the device and the juice. The device is designed so that a doctor can program it to only be used so often. Thereby limiting intake of the drug. I have seen pill despensers that do the same thing for people who use their meds too often. Doesn't matter, if that device gets produced, they might consider our equipment illegal drug delivery devices, like if a company was selling syringes to the general public for illegal drug use.
Yes but you can easily make a vaporizer from a dremel tool:
YouTube - Dremel Tool Mod
The only way to stop this a total lockdown on juice.
YouTube - Dremel Tool Mod
The only way to stop this a total lockdown on juice.
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In-case you haven't seen it:-
Staccato System
Informa Healthcare - Drug Development and Industrial Pharmacy - 34(9):936 - Summary
Staccato System
Informa Healthcare - Drug Development and Industrial Pharmacy - 34(9):936 - Summary
Whew, nice looking device. That could be expensive!
This from WSJ:
This from WSJ:
A gradual reduction of nicotine, to deep lung, which means serious technology in there. Can't wait to see what our "Modders" can make of one of those. I have a feeling this may be a "factory loaded" device, one prescribed time-line of use 117µm. No reloading. No "juicing up". Warranty voided if dissembled! I can't see or don't understand the dosage, I saw something between 1µm and 3µm whatever that means. Aerosol purity 99%. Very interesting!!
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Ventured guess on prescription (yes or no) and cost (under $300 or over $300).
I would say Yes prescription, over $300 cost.
Modder's delight? YES
I would say Yes prescription, over $300 cost.
Modder's delight? YES
Looks like a jazzed up rescue inhaler to me. 
And I'm sorry, but that thing wouldn't even come close to imitating the hand to mouth habit of smoking that most of us deal with.
And I'm sorry, but that thing wouldn't even come close to imitating the hand to mouth habit of smoking that most of us deal with.
It's Pharma! Not for 'helping', in the large sense. This is the age of technology though. Gotta be worth investments! I've got the index listed, just to watch it.
It looks to me like this device is fundamentally different from the devices we are using because it uses a process that chemically changes the nicotine rather than a simple change in state from liquid to vapor.
However, even if they were marketing something that was functionally the same as an "electronic cigarette" like we use, as long as Judge Leon's decision is upheld manufacturers would be allowed to submit vaporizers for sale as a medical device if they want to market it as a treatment for a disease just like exercise equipment manufacturers can sell their devices to doctors and hospitals for therapeutic use OR sell them as consumer devices if they aren't marketed for use as a medical or therapeutic device.
Because many e-cig users aren't necessarily wanting to quit using tobacco products entirely but simply want to reduce or eliminate the hazards of combustion, the public health is best served by allowing businesses to sell smoke-free alternatives as modified risk tobacco products, but that does not mean that they can not ALSO be sold as medical devices for the treatment of a disease if a manufacturer provides clinical evidence of safety and efficacy for the intended medical or therapeutic use.
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Totally agreed, Thulium, this is tremendously sophisticated, many steps beyond the inhaler type devices. Premeasured diminishing doses of spray. Imagine the R&D price tag. Looking back, I think the sophistication of the cigarette industry was significantly underestimated for decades.
Once again equating smoking cessaion with nicotine cessation.
Big problem, because I don't want to quit nicotine.
Until they approve something that doesn't require complete nicotine cessation, they won't decrease smoking rates. The only people who will turn to this are the same people who use NRTs and they will still be on the same rollercoaster.
I quit 3 times for over 12 months - for each of my pregnancies. But I still went back to smoking. The answer for 21% of the population simply ISN'T nicotine cessation.
Big problem, because I don't want to quit nicotine.
Until they approve something that doesn't require complete nicotine cessation, they won't decrease smoking rates. The only people who will turn to this are the same people who use NRTs and they will still be on the same rollercoaster.
I quit 3 times for over 12 months - for each of my pregnancies. But I still went back to smoking. The answer for 21% of the population simply ISN'T nicotine cessation.
And, statistically speaking, the answer to 95% of opiate addicts disorder isn't opiate cessation(it just doesn't work for them). They just don't want to quit either. And, frankly, the policy in the USA with respect to their problem may start looking like a future policy towards nicotine.
My point is, I hope all vapers who are such ardent supporters of their right to having a harm reducing alternative to smoking(via continued PROVEN SAFE nicotine administration); are joining other addicts rights groups, such as SSDP, drugpolicy.org, LEAP.CC, etc..... as I have. No addict regardless of their chemical addiction, should be forced to quit(if they choose not to) if they are not harming or bothering anybody else. They should also have the right to the same harm reducing alternatives. Rights taken away from others today or in the past may foreshadow rights taken away from you in the future.
Just my
. Now back to the regularly scheduled thread.
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