R-Pharm: Ardaleva (odelepran)

Ardaleva (odelepran) is a pan-antagonist of opioid receptors. Exclusive rights to research and commercialization of odelepran in Russia and a number of other countries were acquired by the R-Pharm group of companies in 2012.

2022: Registration in Russia

On R-Pharm June 28, 2022, the Group of Companies announced the registration on the territory of Russia its own drug Ardaleva (odelepran) for the treatment of patients with. alcohol addiction The issued Ministry of Health RUSSIAN FEDERATION registration certificate is valid until December 2025. The R-Pharm company announced this on June 28, 2022.

The marketing authorization was issued on the basis of the results of the international clinical program and a double-blind randomized phase III trial with the participation of more than 600 patients.

Unlike the closest analogues, odelepran affects not one group of opioid receptors, but all groups, possessing a special receptor binding profile - it acts on the motivational system and reduces the reinforcing effects of alcohol, and also reduces the feeling of euphoria, thereby reducing the desire to consume alcohol-containing products. The drug is designed for use in the treatment of the main stages of alcoholism, including at the stage of the first abuse and the formation of addiction.

The data obtained on the efficacy of therapy in women suffering from alcoholism and on the good tolerability profile of the drug in general, including indications of liver function, are very important. This facilitates its use in patients at risk. We expect that the availability of this therapy for the largest circle of patients will make it possible to turn the tide in society with alcohol abuse, "said Mikhail Samsonov, medical director of R-Pharm.

The production of the pharmaceutical substance and the final dosage form of odelepran is organized at the facilities of the R-Pharm group of companies in the Yaroslavl region.