TWO TYPES OF TRANSDERMAL PATCHES
ARE IN PREPARATION
1- Combined (VLT + 6MH) Patches,
applied at bedtime and removed when waking in the morning, for the treatment of neurological disorders due to insufficient secretions of the 3 pineal hormones:
– at low dosage: delivering, over a period of about 8 hours, 50 micrograms of 6-MH and 200 micrograms of VLT, for the treatment of sleep disorders and nervous breakdowns.
– at high dosage: delivering, over a period of about 8 hours, 100 micrograms of 6-MH and 400 micrograms of VLT, for the treatment of Parkinson’s and Alzheimer’s neurodegenerative diseases.
2- VLT Patches,
applied in the morning, between 8:00 and 12:00, for the treatment of psychoses due to excessive secretions of the 3 pineal hormones. These patches should release in the body doses of 5 micrograms of Valentonin per hour and per kg of body weight.
In the fourth quarter of 2017, 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.