PIQ- PHARMA has applied authorization a dossier of the Epilexide® Syrup 50 mg/ml, 250 ml drug

On December 28, 2021, the Russian company PIQ- PHARMA has applied to the Ministry of Health for Marketing authorization a dossier of the Epilexide® Syrup 50 mg/ml, 250 ml drug (ethosuximide) in accordance with the new regulatory requirements of the EAEU.

Ethosuximide is an anti-epileptic medication, also called an anticonvulsant. Ethosuximide is used alone or in combination with other medications to treat absence seizures (also called "petit mal" seizures) in adults and children.

In addition to the absence seizures, Ethosuximide is included in the treatment protocol for epileptic encephalopathy, which causes mental retardation.

Communities of doctors and parents of young patients have repeatedly signaled shortages of this drug, as foreign companies have stopped bringing the capsuleshaped drug to Russia, and no syrup has been registered in Russia.

Epilexide® syrup has passed the necessary tests, including a clinical study of bioequivalence to the reference drug Zarontin (Pfizer) and will allow the treatment of epilepsy in children from the age of 3. After obtaining the registration certificate, the drug will be produced at PIQ-PHARMA`s own manufacturing site in the Belgorod region. It is expected that the shipment of the drug to the pharmacy network will begin in mid-2023.

Epilexide® syrup will become part of the anti-epileptic portfolio of the Russian company PIQ-PHARMA, where there is already a generic gabapentine, as well as its own original antiepileptic Dibublon® (phenozanoic acid) for use in combined therapy of focal forms of epilepsy.

PIQ-PHARMA`s strategy is to ensure that original and generic antiepileptic drugs are continuously available to patients requiring constant seizure control.