When creating new medications, researchers are increasingly turning to the possible use of internal, “own” regulators of the human body. Such compounds include the so-called regulatory peptides. Currently, peptides are one of the most studied classes of biologically active substances. In recent years, numerous data have been obtained, indicating the effect of regulatory peptides on various body systems, in particular the central nervous system. A specific feature of the peptides is their high efficiency at low dosages, the rapidity of the effect onset and the absence of adverse events. The listed properties of these substances allow us to consider endogenous peptide regulators and their analogues as a basis for creating next-generation drugs.
Semax is one of the first medicines of peptide nature made in Russia. This drug was developed on the basis of a fragment of adrenocorticotropic hormone – ACTH (4-10) in the Institute of Molecular Genetics of the Russian Academy of Sciences and at the Department of Human and Animal Physiology of the Faculty of Biology, Moscow State University.
In the mid-1960s, it was shown that ACTH fragments lacking hormonal activity can stimulate training and memory abilities in animals. However, the clinical use of these natural peptides was not possible, since their effects were short-term (the duration of the action did not exceed 30 minutes). The task the researchers faced was creating an analog of the ACTH fragment deprived of hormonal activity and having pronounced and long-lasting stimulating effect on the learning and memorization processes. Such a preparation was finally developed. Experiments involving animals have shown that the introduction of Semax in low doses stimulates learning process, weakens amnesia, normalizes the blood circulation of the brain and has an antihypoxic effect. At the same time the duration of the drug action was 60 times greater than that of natural ACTH fragments – up to 24 hours. In addition, it has been shown that all of the mentioned Semax effects persist with an intranasal route convenient for use in clinical and outpatient practice. Further studies involving volunteers and Semax clinical trials were carried out as well. In accordance with the order of the Ministry of Health and Medical Industry of the Russian Federation No. 294 as of December 20, 1994, Semax was registered in the Russian Federation and authorised for medical use and industrial release (marketing authorization No. 94/294/10).
Effects of Semax
Semax is a stimulant of mental activity. Testing the effectiveness of Semax prophylactic use to optimize the activity of operators engaged in intensive production was carried out with the participation of employees of the Permskaya GRES power plant operator services.
It was demonstrated that a one-time intramuscular introduction of Semax 1-2 hours prior to testing led to a significant decrease in the number of erroneous reactions of operators at the end of the working day. Repeated testing (the day after taking Semax) also showed a decrease in number of errors in the group of subjects taking Semax, compared with the control group. Subsequently, in addition to the studies described above, more than 300 healthy people used Semax to maintain and stimulate mental performance in challenging circumstances. It was concluded that Semax has a positive effect shown in prolonged stimulation of attention and operative memory in humans; the drug was further recommended for widespread use as a therapeutic and prophylactic agent stimulating mental performance.
However, the subsequent clinical trials of Semax showed that the possible scope of its use is much wider. The results of these studies were presented in detail at the IV Russian Congress “The Man and the Medicine”.
Semax vs strokes
Semax involved in treatment of strokes. The study of Semax’s effectiveness in the treatment of acute ischemic stroke was conducted at the Neurology Department of Moscow State Medical University (Academician of the Russian Academy of Sciences E. I. Gusev, Prof. V. I. Skvortsova). The drug was used in the treatment of 30 patients. Strong evidence of Semax’s positive action in the therapy of strokes and post-stroke states on a wide range of indications, including dynamics and completeness of recovery processes, has been obtained. Therapeutic effect of Semax in the treatment of patients with organic cerebral lesions. The studies conducted at the Institute of Neurology of the Russian Academy of Medical Sciences demonstrated the positive effect of Semax in the treatment of chronic progressive disease of the central nervous system, the Huntington’s chorea (initial stage, hyperkinetic form, intellectual-mnestic disorders of varying degrees of severity). The 10-days treatment course with Semax led to the improvement of the condition in more than 85% of patients: activity increased, headaches disappeared, sleep normalized, involuntary movements decreased, the parameters of auditory memory, attention, mood, performance improved. Tests of the therapeutic effect of the drug in the treatment of cerebro-vascular diseases (including the initial manifestations of cerebral circulatory insufficiency, dyscirculatory encephalopathy) also showed a positive effect of Semax. The most distinctly this was expressed in performance increasing, improving of cognitive abilities and hearing and speech memory, correcting sleep disorders, reducing the response time to simple and complex stimuli. The clinical trials of Semax were carried out at the Department of Neurosurgery of the Military Medical Academy studying its efficacy in the correction of post-traumatic (postoperative) cerebral cortex function impairments in neurosurgical patients. It was demonstrated that a 5-day course of treatment with Semax significantly improves the mnestic function in terms of short-term and long-term memory of different modalities in comparison with the control group of patients receiving only conventional treatment.
Semax vs Astheno-neurotic disorders
Therapeutic effect of Semax in treatment of astheno-neurotic disorders. The studies conducted at the Department of Psychiatry of the Military Medical Academy demonstrated the positive effect of Semax in the treatment of patients with astheno-neurotic syndrome and expressed vegetative dystonia, hypochondriac syndrome and vegetative crisis. It was shown that a 5–7-day course of treatment with Semax leads to a general activation of behavior and decrease in lethargy and fatigue. From the third to the fourth day of Semax therapy, the phenomena of emotional lability, irritability, mental tension decreased, the mood improved gradually, concentration of attention increased, memory and mental performance improved.
Semax vs anesthesia
The effectiveness of Semax in correcting mnestic functions after anesthesia. Studies carried out at the Department of Neurosurgery at the Military Medical Academy showed that Semax course therapy helped to restore mnestic functions faster after anesthesia with the use of calypsol in patients operated on for discogenic radiculitis, i. e. without brain pathology. At the same time, there was an improvement in the indices of immediate and delayed visual and verbal memory, attention. The data obtained indicate the prospect of using Semax in anesthesiology and surgery in the early postoperative period for the prevention and treatment of postanesthesia complications.
Semax vs migrane
Therapeutic effect of Semax in the treatment of migraines and facial pains associated with the trigeminal nerve pathology. Employees of the Research Institute of Traditional Methods of Treatment of the Ministry of Health of the Russian Federation demonstrated that Semax treatment helped to jugulate the pain syndrome in patients with certain forms of migraine headaches and trigeminal neuropathy. The most pronounced effects were observed when combined with reflexotherapy.
Based on the studies conducted, the clinicians recommend the following dosages of Semax:
- as a stimulant for mental performance – 0.2 mg (0.2 ml solution) intranasally once a day;
- treatment and rehabilitation of patients with asthenoneurotic symptoms and some organic damages of the brain – 2.5–5 mg per day intranasally for 5–10 days;
- treatment of migraines and neuropathy of the trigeminal nerve – 2.5–3 mg intranasally 3–5 times for1–2 weeks;
- treatment of acute ischemic stroke of moderate severity – 6 mg twice a day intranasally for a week; in case of the severe condition of patients – 9 mg twice a day intranasally for a week.
Contraindications and side effects
Pregnancy, lactation period, diseases of the endocrine system, acute psychotic states, disorders accompanied by anxiety. Side effects and complications associated with taking the drug in patients were not observed. There were no signs of a drug addiction or drug self-tapering following the chronic use of Semax.