The Ministry of Health plans to add tapentadol to the list of narcotic drugs. The drug is used for analgesia in acute and chronic pain syndromes. It is proposed to establish a quota for the production, storage, import and export of tapentadol.

The Ministry of Health has prepared a draft government decree on the inclusion of a substance with the INN tapentadol in the list of narcotic drugs. The document has been published on the portal of legal acts for public discussion (regulation.gov.ru/p/147816).

Tapentadol belongs to the pharmacotherapeutic group of analgesic narcotic drugs, in terms of clinical efficacy it is close to such opioids as morphine (mu-opioid receptor antagonist).

According to GRLS data, two drugs with INN tapentadol are registered in Russia: Palexia and Palexia Retard by Grunenthal. The latter is included in the List of Vital and Essential Drugs.

The draft resolution proposes to establish a new state quota for the production, storage, import and export of tapentadol. It will amount to 1100000 grams.

The decree will come into force 180 days after the day of its official publication.