CBD-based Trunerox OK’d as add-on Dravet treatment

The INVIMA in Colombia also approved drug for seizures in LGS

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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The National Institute of Drug and Food Surveillance (INVIMA) of Colombia has approved Trunerox as an add-on treatment for seizures in people with Dravet syndrome and Lennox-Gastaut syndrome (LGS).

Trunerox, which was developed by the Canadian biopharmaceutical Avicanna, is a proprietary oral formulation of 10% cannabidiol (CBD), the most common nonpsychoactive cannabinoid compound in the cannabis plant. CBD is able to mimic natural compounds by acting on brain receptors, which may cause seizures when they’re faulty.

Avicanna develops, manufactures, and commercializes plant-derived cannabinoid-based products. Trunerox is its first approved medication.

“The approval of our first pharmaceutical product is an exceptionally significant milestone and a major step toward our long-term vision as a biopharmaceutical company with the aim to serve patients with unmet medical needs,” Aras Azadian, CEO of Avicanna, said in a company press release.

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What is Trunerox?

Dravet syndrome is marked by treatment-resistant seizures that usually start in the first year of life. Other symptoms soon follow, including changes in behavior and developmental delays, along with features of autism spectrum disorder. Like Dravet syndrome, LGS is marked by recurring seizures.

According to Avicanna, Trunerox’s approval followed a verification that it complied with all legal, technical, and pharmacological requirements in Colombia. Trunerox’s manufacturing is conducted at Altea Farmacéutica in Bogota, following good manufacturing practice (cGMP) standards, which are set to ensure that batches of a medicine are produced with a consistent high quality. The CBD used in the medication is manufactured at Avicanna’s majority-owned subsidiary, Santa Marta Golden Hemp SAS.

The first formulation of cannabidiol to be approved for Dravet syndrome and LGS was GW Pharmaceuticals’ Epidiolex. The therapy is approved in the U.S. for patients ages 1 or older with these conditions. In Europe and Scotland, it’s approved under the brand name Epidyolex to treat seizures in patients with Dravet or LGS ages 2 or older in conjunction with clobazam, an antiepileptic medication.