Production of one of the world's most sought-after drugs for migraine therapy starts in Moscow
12 July 2023
The Russian pharmaceutical company NovaMedica has announced the production and market launch of the first large batch of the drug Relonova® intended for relief of migraine-associated headaches. The drug is based on the Rizatriptan molecule, which for the first time is fully localized in Russia, from development and manufacturing to introduction in the specialist prescription practice. Rizatriptan is one of the most sought-after molecules in the world for relief and alleviation of migraine symptoms.
Relonova® is designed for acute treatment of headaches caused by migraine attacks (with or without aura) in patients over 18 years of age. It can be used for a long history of migraine, when the effectiveness of other painkillers is significantly reduced.
Relonova® is manufactured at the capacities of the Technological Center NovaMedica Innotech (100% subsidiary of NovaMedica, portfolio company of RUSNANO) located in Technopolis Moscow. To date, the facility has produced more than 140 thousand packs of the new drug, which is released in the form of 10mg tablets. Relonova® was launched in the market on July 7 and will be available for purchase in pharmacies and for ordering as early as this month.
According to the IQVIA analytical agency, in 2022, the volume of the Russian market of drugs for the treatment of migraine amounted to about 2 billion rubles, which is 24% more than in the previous year.
Elena LITVINOVA, CEO of NovaMedica:
- We have been developing a portfolio of drugs for the treatment of diseases of the central nervous system since 2018. It covers those segments of the CNS field where the need for medicines in Russia is not fully met – vascular cognitive disorders, neuropathic pain, Alzheimer's disease, schizophrenia and bipolar disorders, migraine, sleep disorders and others. NovaMedica's own-development drugs are intended to meet precisely these requirements from the medical community and patients, and their local manufacturing will ensure stable supplies to the domestic market. With our work, we prove that Russian manufacturers are successfully fulfilling the objective of providing patients with modern and innovative drugs, despite the challenges posed by the external environment.
Zakhar LEIKIN, Medical Director of NovaMedica:
The burden of migraine as a chronic disease is not only due to the severity of attacks, but is largely determined by its impact on work capacity, social activity and family relationships. Migraine is the second most prevalent cause of adjustment problems and results in a more significant impairment of functional activity than all other neurological disorders[8]. An analysis of data from epidemiological studies done in recent years shows a steady increase in the number of cases of migraine in the population, especially among young people.
The efficacy of Rizatriptan 10mg in acute migraine treatment has been well demonstrated in a number of randomized, double-blind, placebo-controlled trials (RCTs). A meta-analysis of seven Phase III RCTs involving a total of 4,814 patients treated for at least one migraine episode showed that Rizatriptan 10mg was significantly (p<0.001) more effective than placebo in relieving pain within 2 hours after ingestion (18% and 37%, respectively), maintaining a pain-free status for 24 hours (7% and 25%, respectively), reducing the severity of nausea, photo- and phonophobia, as well as functional disability[5,6]. Rizatriptan has been shown to be highly effective in preventing migraine recurrence within 24 hours of taking the drug, without the need for repeated pain medications[7].
About the disease:
Migraine is one of the most common diseases affecting the quality of life and work capacity of the adult population. According to the WHO, 50-75% of people aged 18-65 in the world will have a headache within one year, and more than 30% of them reported migraine. Between 1.7% and 4% of the world's adults suffer from headaches lasting 15 or more days every month[3]. Adult women are afflicted 2.5-3 times more often than men. The frequency and intensity of migraine attacks reaches a maximum at the age of 35-45.[1,2]
At the same time, according to the 75th World Health Assembly (May 2022), disorders of the nervous system are the leading cause of disability-adjusted healthy life years (DALYs) lost and the second leading cause of death globally: 9 million people in the world die every year due to neurological disorders. Migraine (16.3%) is second only to stroke (42.2%) in terms of frequency of DALYs neurological factors[4].
In Russia, according to the results of population studies cited in the Clinical Guidelines of the Ministry of Health[1], the annual prevalence of migraine is 15.9%-20.8% among the adult population (aged 18 to 65).
Information on the Company:
NovaMedica is a Russian pharmaceutical company created in 2012, a portfolio company of RUSNANO JSC. NovaMedica’s strategy is aimed at search and localization in Russia of innovative pharmaceutical products and creation of new drugs under its own R&D program. NovaMedica actively builds and expands a portfolio of CNS products, which is formed by its own developments. The Company has most suitable infrastructure for commercialization and promotion of both its own and partners’ drugs. In 2022, the Company received a certificate of conformity to the GOST R ISO 9001-2015 standard for its quality management system regarding wholesale trade in drug products for human use, including storage and transportation.
In 2017, NovaMedica opened in Moscow the R&D Center NovaMedica Innotech (100% subsidiary of NovaMedica). The Center has state-of-the-art technological capacities, carries out research, development and manufacturing of innovative and effective drug products, including on a contractual basis. Innotech is GMP-compliant and has been issued a GMP certificate by the Russian Ministry of Industry and Trade. Production capacity of the R&D Center is up to 150 mln units per year (tablets, soft and hard gelatin capsules with various fillers: microtablets, pellets, granules, powders).
See more information at www.novamedica.com
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Sources
1. Clinical recommendations of the Russian Ministry of Health on Migraine, year of approval: 2021 https://cr.minzdrav.gov.ru/recomend/295_2
2. Osipova VV, Tabeeva GR. Primary headaches: diagnostics, clinical picture, therapy: Practical guidelines. M.: Medical Information Agency Publishing House LLC, 2014; 336 p.
3. Headache disorders: Website of the World Health Organization. https://www.who.int/ru/news-room/fact-sheets/detail/headache-disorders)
4. Draft Intersectoral Global Action Plan on Epilepsy and other Neurological Disorders 2022–2031. 75th World Health Assembly. A75/10 Add.4 April 27, 2022 ã. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_10Add4-ru.pdf
5. Láinez MJ. Rizatriptan in the treatment of migraine. Neuropsychiatr Dis Treat. 2006 Sep;2(3):247-59. doi: 10.2147/nedt.2006.2.3.247.
6. Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x
7. Wellington K, Plosker GL. Rizatriptan: an update of its use in the management of migraine. Drugs. 2002;62(10):1539-1574. doi:10.2165/00003495-200262100-00007
8. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators (2017). Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet (London, England), 390(10100), 1211–1259. https://doi.org/10.1016/S0140-6736(17)32154-2
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