Alexza Pharma licenses e-cig like smoking cessation product

[markarich159]

Possible the first to market an approved form of e-cig like product in the USA. Check out the article:

Alexza Pharma licenses smoking cessation product - BusinessWeek

and here's the system:

Staccato System

 

[LowThudd]

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.

 

[kylewinther]

no, that seems like the nicorette inhaler. That thing taste like crap, and all you do is inhale, nothing gets exhaled like electronic cigarettes. This is simply in inhaled nicotine deliver device. I dont see a battery like e-cigs. h

 

[Shotline]

I don't like the looks of this.

 

[LowThudd]

no, that seems like the nicorette inhaler. That thing taste like crap, and all you do is inhale, nothing gets exhaled like electronic cigarettes. This is simply in inhaled nicotine deliver device. I dont see a battery like e-cigs. h

It does use an electric heater element from the description. Staccato System

 

[markarich159]

no, that seems like the nicorette inhaler. That thing taste like crap, and all you do is inhale, nothing gets exhaled like electronic cigarettes. This is simply in inhaled nicotine deliver device. I dont see a battery like e-cigs. h

That's what I thought at first but it's not. It works quite like an e-cig watch the animation:

Staccato Animation

 

[trying]

They said early stage trials by late 2011.

Which probably means available to the public 2013/2014 and that is if there are no problems.

 

[LowThudd]

They said early stage trials by late 2011.

Which probably means available to the public 2013/2014 and that is if there are no problems.

Heres hoping. Honestly, I think it is a great drug delivery tool, I just wish they haden't made it out to be a viable smoking cessation aid. Really throws a wrench in the workings of our hobby(it is that, isn't it?)

 

[markarich159]

from other thread:

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.

 

[BuzzKill]

The main problem is that it looks like a sanitary napkin ! not real good IMO !

 

[markarich159]

They said early stage trials by late 2011.

Which probably means available to the public 2013/2014 and that is if there are no problems.

It depends on where they are in the process. The average time to take a new drug entity (from the drawing board) to market is 8 to 12 years. However, it appears they may already have passed through the initial pre-clinical phases & possible the the initial phase of human clinical trials. The start of Phase 2 would still be considered an "early stage" trial, in that case 2013-2014 may be right on. I would think if they are starting from Phase I in 2011 , you'd be looking at more like 2016-2018. But it really all depends on the drug. A new cardiac arrythmia drug is going to take much more intensive(thus longer) clinical trial time. Also, the FDA allows some drugs to be fast-tracked depending on clinical situation and required post marketing surveillance.

 

[LowThudd]

It depends on where they are in the process. The average time to take a new drug entity (from the drawing board) to market is 8 to 12 years. However, it appears they may already have passed through the initial pre-clinical phases & possible the the initial phase of human clinical trials. The start of Phase 2 would still be considered an "early stage" trial, in that case 2013-2014 may be right on. I would think if they are starting from Phase I in 2011 , you'd be looking at more like 2016-2018. But it really all depends on the drug. A new cardiac arrythmia drug is going to take much more intensive(thus longer) clinical trial time. Also, the FDA allows some drugs to be fast-tracked depending on clinical situation and required post marketing surveillance.

The fact that it is designed to despense pre-existing drugs may cause it to come about earlier than you would normally expect.

 

[xg4bx]

"aimed at smoking cessation"

The video says "drug" though, it doesn't say nicotine. It doesn't say nicotine anywhere on the site. I guess it could vape Chantix.

"In vivopharmacokinetic studies in an animal model conducted with a commercially available migraine drug show that the Staccatosystem results in more rapid absorption than subcutaneous injection or oral administration."

"Approved drugs for the treatment of many acute and intermittent conditions, such as antipsychotics to treat agitation, triptans to treat migraine headaches and benzodiazepines to treat anxiety, are typically delivered either in tablets or by injection. Traditional inhalation technologies are also being developed to treat these conditions."

Imo THIS is clearly a drug delivery system, e-cigs are tobacco alternatives. Personally I see a difference.

 

[D4rk50ul]

Doesn't look threatening to me, but don't be surprised when the real deal comes along. If I was to place a bet right now it would be that the FDA's "friends" end up making an identical product that is somehow different enough to be "Approved". They are banning and stuff to delay long enough to make the cash on this groundbreaking and lifesaving technology. If they can stall out the industry in the US just long enough, they can come in with major capital and overtake it.

 

[markarich159]

The fact that it is designed to despense pre-existing drugs may cause it to come about earlier than you would normally expect.

That's a possibilty, conversely, since it is a total "novel" delivery system, it may take even longer. Until some more hard data comes to light about what this actually is and where they are in product development; it's really anybody's guess. I would hope, for the ecig industry's sake, that it stays in clinical trials for as long as possible.

 

[LowThudd]

That's a possibilty, conversely, since it is a total "novel" delivery system, it may take even longer. Until some more hard data comes to light about what this actually is and where they are in product development; it's really anybody's guess. I would hope, for the ecig industry's sake, that it stays in clinical trials for as long as possible.

Yup.........