The Russian pharmaceutical company Nizhpharm has expanded its neurological drug portfolio with the launch of Anxilera (etifoxine), an anxiolytic with a dual mechanism of action, now available in Russia. The medication, intended for patients with varying severity of anxiety and related psychosomatic disorders, has completed all registration procedures and officially entered the Russian market, as the press service of Nizhpharma told GxP News.
The State Register of Medicines lists MSN Organics Private Limited as the manufacturer of the pharmaceutical substance. The prescription anxiolytic will be available in two formulations: No. 24 for initiating therapy and No. 60 for course treatment.
Etifoxine is a benzoxazin that does not belong to the benzodiazepine family, but that has anxiolytic properties (reduces anxiety). It was developed by French company Biocodex. Data on etifoxine as a potential psychotropic compound first emerged in the 1970s. From 1995 to 2007, more than 11.3 million patients received therapy with etifoxine, which is now used in over 40 countries. In Russia, Biocodex registered the drug under the trade name Stresam.
Nizhpharm noted that etifoxine has been extensively studied in neurotic disorders through placebo-controlled and comparative trials, and the company stressed that they plan to further expand the evidence base of the drug. A multicenter observational study involving 300 patients with anxiety and somatic symptoms is scheduled to begin in 2025, aiming to assess the drug’s effectiveness and tolerability compared to other anti-anxiety medications.
According to the World Health Organization, more than 300 million people worldwide are living with an anxiety disorder. Referring to monitoring data from the Institute of Psychology of the Russian Academy of Sciences, Nizhpharm stated that as of December 2024, 26 million Russians exhibited symptoms of anxiety, though the actual number may be higher.