The perfect analgesic?
The world's first safe analgesic has passed preclinical tests
The world's first analgesic without side effects has successfully passed the stage of preclinical trials. The innovative drug was created within the framework of the federal target program "Pharma 2020" by a scientific group, which included specialists from IPHET SB RAS, TSU and the E.D. Goldberg Research Institute of Pharmacology and Regenerative Medicine of the TNMC. The industrial partners of the project are enterprises from the TSU innovation belt: Sibtermochim LLC and Chemical Technologies Research Center. The basis for the analgesic, which has no analogues, was an altered molecule of the powerful explosive CL-20.
– CL-20, or hexanitrogexaazaizovurcitan, is well known as the strongest high–energy substance, and only since 2003 it has been tried for medical purposes, - says Alexander Vorozhtsov, Vice-rector for Scientific and Innovative Activities of TSU, Chief Researcher of IPHET SB RAS, Professor Alexander Vorozhtsov.
– With the help of computer modeling, a new molecule with the alleged activity of an analgesic was created. A new first-in-class substance was obtained by the method of directed synthesis. Preclinical studies have confirmed its unique medicinal properties.
Three-year studies of the properties of a new drug, called thiovurcin, were carried out by specialists of the E.D. Goldberg Research Institute on mice, rats, rabbits, guinea pigs and fruit flies. The results showed that thiovurcin surpasses many well-known analgesics in strength and duration of exposure and can effectively relieve pain of any etiology. Along with the effectiveness, pharmacologists studied the degree of damaging toxic effects in animals to predict the development of side effects in humans.
– According to the results of preclinical studies, no properties have been identified that could hinder further research of this analgesic in clinical trials, – adds a leading researcher at the E.D. Goldberg Research Institute, TNIMC, professor Svetlana Krylova. – The data obtained indicate that thiovurcin does not cause the effects characteristic of opioid analgesics – there is no negative effect on the gastrointestinal tract, central nervous system (does not cause the development of euphoria and sedative effect), does not depress the respiratory center and the hematopoietic system. The most important thing is that even after taking an analgesic for a long time in the experiment, there is no development of drug dependence and withdrawal syndrome.
Along with this, the effect of thiovurcin on the immune system and reproductive function of animals after taking it, which lasted from two weeks to three months, was studied. Genotoxic and mutagenic effects leading to DNA damage were not detected. The data obtained indicate the safety of its use by men and women planning childbearing.
Now the developers have to go through the last and most expensive stage – clinical trials of the drug. The cost of research that gives an objective picture starts from half a billion rubles. That is why a considerable part of new pharmacological developments simply does not reach the pharmacy. Currently, research organizations – the creators of thiovurcin – are negotiating with several pharmaceutical companies, including abroad, and are looking for an investor who will be ready to finance clinical trials.
According to the developers, the innovative drug may help solve the global problem facing the whole world, especially the United States – an opioid crisis caused by the use of synthesized analgesics. Their consumers are primarily people with chronic pain, forced for several months or even constantly to take powerful painkillers that cause severe dependence, and in case of overdose can lead to death.
– The US authorities are allocating a billion dollars to create an analgesic that will be very effective, but at the same time safe for people, in Russia this substance has already been synthesized by us. Moreover, a ready–made dosage form has been created - capsules. Several patents have been obtained for the development," notes Alexander Vorozhtsov. – I am sure that in the foreseeable future we will be able to find a serious investor to support clinical trials and registration of an analgesic, and then Russia, firstly, will be able to more effectively solve the problems of patients who suffer from chronic pain, and secondly, with the help of thiovurcin, will secure an advantage in the global pharmaceutical market.
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