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The correspondent’s words that favipiravir was considered insoluble until now look strange: the substances in which it dissolves are known to everyone. For example, in the WHO recommendations on combating counterfeit drugs it says about spectrophotometric studies of favipiravir solution in hydrochloric acid. So the task facing the Saransk pharmacologists, in fact, obviously was to find a solvent that would not adversely affect the properties of the drug and the patient’s body.
But in which countries of the world they worked on the creation of an injectable form of favipiravir remains unknown. In the same WHO recommendations, there is a disclaimer: “does not imply the proven effectiveness of favipiravir in the treatment of COVID-19, and also does not recommend its therapeutic use.” And this is no coincidence: after the outbreak of the epidemic, a number of studies were carried out in different countries, and none of them proved the effectiveness of the drug. In July 2020, “Pharmaceutical Bulletin” wrote:
“Japanese researchers have completed a clinical trial of favipiravir that fails to conclude that it is effective against COVID-19. The drug has been used in more than 20 clinical studies around the world. <…>
Patients who received the drug at the beginning of the study showed more pronounced improvement in the condition compared to those who took the dose later. However, these results did not reach statistical significance, said Dr. Yohei Doi, who leads the study at Fujita Health University.
In August 2021 in European Journal of Clinical Microbiology & Infectious Diseases An article by Turkish researchers comparing the results of 12 clinical trials of favipiravir has been published. In it made this conclusion:
“Our meta-analysis found no significant difference between favipiravir treatment and comparators (that is, already registered drugs that are used for the same purposes) in terms of mortality and the need for mechanical ventilation. There is no significant difference in mortality rates and mechanical ventilation requirements between favipiravir treatment and standard treatment in patients with moderate to severe COVID-19. ”
More recently, in November 2021, a Canadian company Appili Therapeutics, incoming a consortium of manufacturers of favipiravir (known in the West under the patented names “Avigan” and “Rikonus”), reported about the results of their research:
“A phase 3 clinical trial of oral Avigan® / Reeqonus ™ for mild to moderate COVID-19 was not statistically significant for the primary endpoint of time to sustained clinical recovery. Additional analysis of the study data is under way. The clinical study, conducted at 38 research centers in the United States, Mexico and Brazil, enrolled 1,231 patients with mild to moderate severity of COVID-19.
“While we are disappointed with the initial trial results, we remain firmly convinced that safe and effective oral antiviral drugs are urgently needed for patients battling COVID-19. We want to thank all the patients who participated in the study and we hope that the information from our trial will help guide research and development towards finding new potential treatment options for COVID-19, ”said Dr. Armand Balboni, Chief Executive Officer by Appili Therapeutics “.
As he wrote The Insider, favipiravir, positioned as a domestic drug (patented names “Avifavir”, “Areplivir” and “Coronavir”), in reality represents a generic of a Japanese drug purchased by Russian companies in China at extremely low prices. Among these companies is Promomed, whose head took part in the news of the week.
In addition, favipiravir is highly toxic; it is prohibited for children, pregnant women, lactating women, and people with severe liver or kidney failure. Due to the high likelihood of a negative effect on the fetus, people taking the drug are recommended to pay special attention to contraception for several months. Also, when researching in Japan, it was identifiedthat the use of the drug can lead to motor disorders in patients: restless legs syndrome, as well as an increased risk of falls. Experts believe this may be due to the drug’s effects on the central nervous system.
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