TWO TYPES OF TRANSDERMAL PATCHES WILL BE USED
1- MIXED PATCHES (VLT + 6-MH)
The role of mixed patches is to strengthen a physiological secretion of 2 hormones, Valentonine and 6-methoxy-Harmalan, insufficient. They must therefore be applied at the same time as the nocturnal pineal secretion of the 2 hormones, which lasts 8 hours; that is, between 10pm and 6am, at least. The patches can be kept longer, but to wake up properly, the patch must be removed so that the 6-MH levels in the body become prevalent relative to the VLT.
In subjects for whom the secretions of the 2 pineal hormones were high enough to be accurately measured, we were able to show that the amounts of VLT and 6-MH delivered by the pineal gland during the night are identical. The galenic formulation of the mixed patches has therefore been developed to enable them to deliver to the body, during the period of application of the patches, identical amounts of the 2 pineal hormones. The dose administered is set according to the area of application of the patch. It corresponds to 1 microgram of each hormone per cm2 of patch.
– Low dosage: 1 patch of 10 cm2 (10 micrograms of each hormone) applied at bedtime and removed in the morning after awakening, after 8 hours of application, at least, for the treatment of sleep disorders and nervous breakdowns.
– High dosage: patches of 20 to 60 cm2 (20 to 60 micrograms of each hormone) applied at bedtime and removed in the morning after awake, after at least 8 hours of application, for the treatment of Parkinson’s and Alzheimer’s neurodegenerative diseases.
2- SIMPLE PATCHES (VLT)
They will be used in the treatment of psychotic disorders, due to excessive secretion of pineal hormones.
The simple patches will be applied at bedtime and removed around noon, after 14 hours of application.
The purpose of the transdermal administration of Valentonine is to reduce the excess of 6-MH over the VLT by up to 12 hours. From noon, indeed, the amount of 6-MH in the body will be compatible with normal mental functions, without hallucinations.
In the fourth quarter of 2019, the pharmaceutical Laboratories, to which we will have granted licenses to develop the patents for the patches, will request a Temporary Use Authorisation (TUA), in order to immediately make these treatments available to patients.
A TUA (Temporary Use Authorisation) is granted in very specific cases, for discoveries that provide solutions to diseases considered serious, and for which no suitable treatment exists. Neurodegenerative diseases are included therein.
The French National Medicinal and Health Product Safety Agency (ANSM) specifies that “Temporary Use Authorisations (TUA) are granted by ANSM under the following conditions:
– the patented medicinal products are intended to treat, to prevent or to diagnose serious or rare diseases;
– no suitable treatment exists;
– their efficacy and their safety are presumed in the state of scientific knowledge.”
Alzheimer’s and Parkinson’s neurodegenerative diseases, for which no suitable treatments exist, fall within this scope. This is borne out by the fact that, in the case of Alzheimer’s disease, the French Health Authority (HAS) has just acknowledged the absence of effective medicinal products. In fact, it has just recommended cutting back on the reimbursement of 4 available medicinal products (Ebixa® and generics, Aricept®, Réminyl® and generics, Exelon® and generics), which are widely prescribed against Alzheimer’s disease, and whose benefits are deemed insufficient. There is thus a therapeutic vacuum for the treatment of Alzheimer’s disease. Essentially the same applies for Parkinson’s disease. Of course, this TUA will also apply to treatments of other neurological disorders, which result from our discovery: sleep disorders, nervous breakdowns, and psychotic disorders.