Are you kidding me???

[StuckinLA]

This is NOT going to replace e-cigarettes. It may replace the Nicotrol Inhaler, though.

E-cigarettes are NOT an alternative for nicotine addiction treatments like gums and patches, they are an alternative for cigarettes like snus or Orbs. Do not forget that!!

Intended use matters, like Elaine said. If this product is seeking FDA approval as an NRT, then it is NOT intended to be a smokeless tobacco product like e-cigarettes. Its ultimate goal will have to be to wean the user off of nicotine, not be a long-term source of nicotine.

This thing to e-cigarettes is like comparing insulin to sugar-free ice cream for diabetics. One treats a disease, the other is a reduced harm alternative for people with the disease. Very different intended uses!

That is true and intelligent people can see that but remember we're dealing with the FDA here and big pharma, so even a perceived threat like ecig’s has to be crushed.

 

[loden813]

Hummm...may need to place a VERY LARGE order soon....

 

[N2rock]

That is true and intelligent people can see that but remember we're dealing with the FDA here and big pharma, so even a perceived threat like ecig’s has to be crushed.

agreed. Big Pharma has tons of money to dump into lobbyist. If big pharma sees e-cigs as a threat to their bottom line, they will flex their muscle.

 

[fallon74]

I wouldn't carry that thing around I'll stick to my PV.

 

[ckc]

This might not even make it to the first gate.Another drug for the Staccato has FDA approval problems.

Alexza Pharm: FDA Doesn't Approve AZ-004 - TheStreet

 

[rothenbj]

This is NOT going to replace e-cigarettes. It may replace the Nicotrol Inhaler, though.

E-cigarettes are NOT an alternative for nicotine addiction treatments like gums and patches, they are an alternative for cigarettes like snus or Orbs. Do not forget that!!

Intended use matters, like Elaine said. If this product is seeking FDA approval as an NRT, then it is NOT intended to be a smokeless tobacco product like e-cigarettes. Its ultimate goal will have to be to wean the user off of nicotine, not be a long-term source of nicotine.

Kristin, that fine line starts getting crossed by BP when they move forward with their plan to get NRT approved for long term use as a reduced harm product. What is NRT then? Has it to then just become another tobacco product that should be sold behind the counter where the kiddies can't get to it?

 

[otrpu]

Without a vapor, I would expect it to be less effective than a PV. JMHO

Cheers,
otrpu

 

[kristin]

Kristin, that fine line starts getting crossed by BP when they move forward with their plan to get NRT approved for long term use as a reduced harm product. What is NRT then? Has it to then just become another tobacco product that should be sold behind the counter where the kiddies can't get to it?

I look forward to it - makes the anti stance against smokeless tobacco products (orbs, strips, snus) and flavored tobacco replacement products pretty lame, doesn't it!

 

[Oliver]

In the US, under the current medical paradigm, I suspect you're right.

Elsewhere, the UK for instance, I see this taking off pretty damned quick. In the UK the MHRA has already consulted on long-term maintainence NRT.

That said, I also agree that e-cigarettes and long-term NRT satisfy quite different sets of tobacco-consumers' demands. It will be quite interesting to see what vapers make of the new devices (and this is likely to be the first of many) that become available - remember, there are quite a few current vapers for whom e-cigs do not provide full relief.

This is NOT going to replace e-cigarettes. It may replace the Nicotrol Inhaler, though.

E-cigarettes are NOT an alternative for nicotine addiction treatments like gums and patches, they are an alternative for cigarettes like snus or Orbs. Do not forget that!!

Intended use matters, like Elaine said. If this product is seeking FDA approval as an NRT, then it is NOT intended to be a smokeless tobacco product like e-cigarettes. Its ultimate goal will have to be to wean the user off of nicotine, not be a long-term source of nicotine.

This thing to e-cigarettes is like comparing insulin to sugar-free ice cream for diabetics. One treats a disease, the other is a reduced harm alternative for people with the disease. Very different intended uses!

 

[deusXmchna]

Now it makes sense.
I was perusing my firms patent server (it's commercial, much slicker than the uspto site)
last night, and found quite a few applications and/or granted patents by Alexza Pharmaceuticals

 

[Bill Godshall]

If/when the FDA approves this product as a drug device to treat nicotine dependance, I suspect it will cost ten, twenty or thirty times the price of e-cigarettes.

The goal of these documents appears to be to encourage more investors to buy the company's stock.

But as Kristin and Elaine stated, as long as NJOY continues its litigation against the FDA (and now with TW's lawsuit), it appears almost certain that the FDA won't be able to regulate e-cigarettes as drug devices (unless the manufacturer makes a therapeutic claim).

 

[mirinuh]

The discussion about the cost of an FDA-approved NRT is a crucial one in this whole dynamic. 90% to 95% of all FDA-approved NRT's are paid for by third parties- health plans, programs- often from funds that have been allocated to these plans and programs via the US states' attorneys general Master Settlement Agreement. Additionally, OTC NRT is FSA-eligible. That's why the stakes remain so high for pharma companies- there is a pool of money waiting for them. Without getting too technical, the Alexa technology being discussed here is flawed for a number of reasons.

 

[AlbertaClipper]

Without getting too technical, the Alexa technology being discussed here is flawed for a number of reasons.

Aside from them not being a familiar PV, what would those reasons be?

 

[mirinuh]

The Alexa technology vaporizes the active ingredient at very high temperatures versus the way a PV vaporizes an expedient/carrier- PG, VG- at much lower temperatures. This has been an issue in other clinical studies. But, the advantage that this technology does have over the PV- from the perspective of the FDA- is that it can and does deliver a measurable dose of nicotine each and every time, albeit at very high temps and at a very high cost.

Also, since they are going down the pharma path, they are years away from approval. The licensee- Cypress- has been recently acquired by private equity interests and it remains to be seen if they will have an appetite for the long journey of commercializing this technology and this particular product as an FDA-approved NRT- given the very real threat of the disruptive and trans-formative technology of the PV. Still, it could be fast-tracked . . . but given the issues that the Alexa technology has encountered in other clinical trials for other medicants, this may not be the best technology to fast track from an FDA perspective.

 

[Oliver]

Very interesting, Mirinuh - thanks for that.

Quick question: what is the decision-making process vis a vis fast-tracking approval? Who makes it, and on what basis?

 

[mirinuh]

The FSPTCA directs the FDA to fast-track safer, less harmful products on both the tobacco side and also on the pharma and NRT side. It leaves it up to the discretion of the FDA how they accomplish that. Given everything else that the law directs the FDA to do, very few observers are hopeful that this is or will be a priority for them. Star Scientific has applied for fast tracking with some of their tobacco tablets and it remains to be seen if they will be accorded that treatment. Star made the application on the tobacco side as a reduced harm product. My understanding is that they have two applications in and they were the first to apply to the FDA under the FSPTCA.

 

[kristin]

Measurable dose SHOULD only be relevant in a drug treatment, right? I can't imagine that smokeless tobacco or cigarettes deliver the exact same dose every time.

Since this product is trying to be a treatment, it needs measurable dose. Since e-cigarettes are trying to be a smoking alternative, it shouldn't.

 

[mirinuh]

Measurable, repeatable dose should not be an issue with traditional tobacco products. But, it's hard to tell what will happen to nontraditional tobacco products.

 

[AlbertaClipper]

You have some great insights, mirinuh...thanks! I'm not so worried about that thing now.