Apologies for my delay in response to your questions.
At present, if the Intellicig NDD was to claim to "cure nicotine addiction" it would be classified as a medicine and would be under regulation of the MHRA. The Intellicig NDD is not intended to cure nicotine addiction.
Weaning down from a higher level of nicotine to a lower level of nicotine using an e-cig may be achieved by two methods 1) decrease the concentration of nicotine used in the vaporiser 2) decrease the number of inhalations from the device. One currently marketed NRT recommends the latter as only one strength of the nicotine is available for the device.
I cannot say for certain what the MHRA will or will not licence, however it has become apparent in recent reports from the MHRA that an application for a product as a "harm reduction" therapy may well be granted MA.
In fact to the best of my knowledge at least one product has been granted MA on the basis of both harm reduction therapy and also as a nicotine step down product.
As the report released by Intellicig last week was concerning the Cmax of Intellicig NDD relative to that of a tobacco containing cigarette many of your questions cannot be answered from it. Further studies will be necessary to determine the efficacy of the product as both an NRT and harm reduction therapy.
I appreciate that every smoker is different and that there are many beliefs regarding nicotine addiction. Applications to the MHRA may only be based on established scientific evidence. There is scientific evidence to suggest that a treatment that shows similarities to cigarette smoking would be more productive as an NRT than those currently available on the market.
Certainly there are learnt traits associated with smoking due to synaptic plasticity however reduction of nicotine at the correct rate is thought to give adequate time for receptor desensitisation and so if nicotine is slowly reduced the body should, in theory, receive the same feeling of relief and positive reinforcement throughout therapy on a nicotine reduction basis. To put simply, the body should adapt quickly to a reduction in nicotine so much that the body cannot tell that the nicotine dose is slowly being decreased. This therapy is only successful if the nicotine reduction occurs at a slow enough rate so that the mind does not crave nicotine.
Again, due to learnt traits from synaptic plasticity once a abstaining smoker smokes a cigarette again, the behaviour and feelings return and it is likely that the treatment would need to start again. This is similar to the thinking on alcohol addiction, in that it only takes one drink to destroy years of therapy.
Indeed you theory of two types of smoker does seem to hold fast in scientific literature. Published papers have distinguished between a smoker who smokes for positive reinforcement (after a meal etc.) and a smoker who smokes to alleviate nicotine withdrawal symptoms. The latter being more highly addicted to nicotine. It is thought that the smoker who smokes for positive reinforcement may easily abstain from smoking without any difficulty.
Finally to the best of my knowledge NRT does refer to Nicotine Replacement Therapy, certainly with the MHRA, however I am not overly familiar with the FDA.
I hope that I have answered your questions, should you wish for more information please do not hesitate to contact me at
davidl@intellicig.com
Kind Regards
David Lawson
One thing that the currently approved NRTs have in common (at least in the U.S.) is that they come with directions on how to wean down and off nicotine. Was that the plan for Intellicig, too?
If the company goal is NOT to cure the "nicotine addiction" then will you be able to get product approval from your government as a medication?
If the end goal is to cure "nicotine addiction", the question would be whether there is any kind of advantage to starting with a higher nicotine replacement level that more closely replicates nicotine levels from smoking.
It is my personal belief that there are people medically dependent on nicotine. For those folks, it doesn't matter how closely you replicate initial dosages and how slowly you reduce dosages. The cognitive and emotional symptoms increase at a rate that corresponds to the reduction in nicotine dosage--getting worse over time as the dosage is reduced. Once the nicotine is all gone, so is their capacity to remember things and to pay attention.
They begin smoking again in self-defense, and feel normal again within a few hours. Each time I resumed smoking after a period of nicotine abstinence, I felt an intense feeling of relief. Like taking a big drink of water when your throat is parched.
People who don't need nicotine for normal brain function seem to be able to throw away their pack of cigarettes and get on with their lives, suffering little more than some cravings.
I have another theory that would need to be tested. That is that those nicotine users who report getting a "kick" from using it are those who actually can take it or leave it without becoming dysfunctional. Those who require nicotine don't experience the "nicotine high" talked about by others.
It might be parallel to the pain medication oxycontin. Some people "abuse" it to get a feeling of intense euphoria. All oxycontin does for people who are in excruciating pain is to provide relief from the pain. There is no euphoria.
It would seem to me that the advantage of more closely replicating the Cmax from smoking is if the product is intended to be used as a permanent replacement for smoking. That close replication would make the product more acceptable as an alternative.
