Parents of children with epilepsy are asked to provide them with domestic medicine

Parents of children with epilepsy have created a petition in which they ask the state to provide the country with a sufficient amount of domestic drugs with the active ingredient ethosuximide. European analogues were in short supply two years ago – foreign manufacturers were not interested in the Russian market due to state price regulation. The PIK-Pharma company promised to release the Russian drug in mid-2023, but, as Kommersant was told in the Ministry of Industry and Trade, the introduction of the drug into civilian circulation was postponed to the third quarter. The authors of the petition fear that the volume of production of the Russian drug will only cover the needs of the children of Moscow. The Ministry of Health assured that 15 thousand packages of unregistered ethosuximide in capsules will appear in the near future.

A petition on the Change.org platform was prepared by parents of children with absence epilepsy. This is one of the varieties of the disease, which is characterized by the absence of convulsive muscle contractions during an attack. The authors of the appeal ask the country’s leadership to increase the production of the Russian antiepileptic drug Epileksid with the active ingredient ethosuximide.

The shortage of vital European-made anticonvulsants with this active ingredient arose a long time ago: back in September 2021, parents complained about the disappearance of Suxilep from Mibe from pharmacies. As Kommersant told, from January to November 2021, sales of this drug did not exceed 12 million rubles. (24 thousand packages). Experts believe that low profitability of production has led to problems with availability. Since the drug is in the register of essential drugs (VED), the state sets the maximum selling price for it. The maximum maximum registered price for a package of ethosuximide from Mibe was 2222 rubles, and from the Moscow Pharmaceutical Factory – 835 rubles. The last 28,900 packs of ethosuximide went into circulation in February 2020, according to RNC Pharma. In November 2021, the government of the Russian Federation initiated the import into the country of 5,000 packages of a drug with ethosuximide Petnidan, not registered in Russia, from the German Desitin Arzneimittel.

In January 2022, the Russian “PIK-Pharma” began the procedure for registering the drug “Epilexide” in the form of a syrup. It, unlike the drug in capsules, is not included in the list of vital and essential drugs. The company said that ethosuximide would be produced from a substance imported from the Netherlands. PIK-Pharma planned to start deliveries in mid-2023, but the Russian generic is still unavailable.

The author of the petition, the mother of a child with epilepsy from Sochi, Elena Martynova, says that the clinic advised her not to wait for the medicine this year. At the local health department, the woman was warned that the drug was not yet available, and that the volumes that would appear before the end of the year would be enough “only for children in Moscow and partly in the Moscow region.” “When I received information that the drug would not go to the regions, I created this petition. I understand that this year my child will no longer have the drug, but if it is possible to increase the production of this drug, then it would be logical to provide all children with it,” says Ms. Martynova. She explains that the drug based on ethosuximide guarantees 100% suppression of absence seizures. Analogues often do not give the desired effect, so parents are trying to find the original on the gray market. However, it is expensive – a package costs 9 thousand rubles, two or three of them are needed per month, depending on the dosage. In addition, the drug must be used for years and cannot be abruptly withdrawn – and gray markets with their supply are unreliable. “Our family does not have the opportunity to look for the drug on the gray market, so in six months we have introduced and withdrawn two analogues. One had a severe allergic reaction that was incompatible with the use, the other did not work,” continues Elena Martynova. “Now we are trying to give our daughter a third drug. For a long time, it is not recommended for girls, as it affects the possibility of conceiving and bearing a child in the future. But we don’t have a choice.” In the petition, Ms. Martynova wrote that tens of thousands of children were left without the necessary treatment, and called for “act right now.” Over 500 people joined her campaign in two days.

PIK-Pharma did not respond to Kommersant’s request. The Ministry of Industry and Trade reported that the remains of ethosuximide in capsules “in the subjects of drug circulation account for at least 30% of total sales in packages in 2022.” The agency added that the Moscow Pharmaceutical Factory and PIK-Pharma planned to release medicines into civilian circulation in the third quarter of 2023.

The Ministry of Health stated that in 2022, 12,088 packages of ethosuximide were introduced into civilian circulation. In addition, a permit was issued for the “temporary circulation” of a batch of a medicinal product not registered in the Russian Federation containing ethosuximide in the form of 250 mg capsules. 15,000 such packages have been imported into Russia, and their distribution “will be carried out proportionally in accordance with the declared needs of the constituent entities of the Russian Federation.” The Ministry of Health added that, together with the Ministry of Industry and Trade, they are working on increasing the production of another drug with the active ingredient ethosuximide and reducing the time it takes for it to enter the Russian market by the Moscow Pharmaceutical Factory. According to Pharmimex JSC, the production of Suximide in the Russian Federation is scheduled for the second half of 2023.

Natalia Kostarnova