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Zynerba's cannabis drug reduces seizures in children, but adverse effects seen

Zynerba Pharmaceuticals Inc. said its cannabis-based epilepsy medicine Zygel helped reduce seizure episodes in children and adolescents, but results from a mid-stage study also showed that patients experienced adverse events related to the treatment.

Zynerba studied Zygel, a pharmaceutically manufactured cannabidiol gel that is administered over the skin, in a phase 2 trial dubbed Believe 1. The study enrolled 48 patients between ages three and 16 with developmental and epileptic encephalopathy, or DEE — a group of rare conditions including Dravet syndrome in which seizures are often triggered by hot temperatures or fever, and Lennox-Gastaut syndrome, a severe form of the disease characterized by multiple and concurrent seizure types.

The only cannabis-based medication approved in the U.S. for the treatment of Dravet syndrome and Lennox-Gastaut syndrome is a liquid oral formulation sold by GW Pharmaceuticals PLC as Epidiolex.

While 48 patients were enrolled, the company studied the medicine's effect in 33 subjects with either focal impaired awareness — also known as partial seizures — or convulsive seizures, which affect the whole body. These patients experienced a 44% to 58% monthly median reductions in seizures two months from the start of the treatment, and the benefit was sustained at the six-month mark.

Some patients were excluded from the evaluation because the company could not categorize their seizure types, though Zynerba said further analyses are warranted in these subjects.

Results also showed that 96% of patients experienced a treatment-emergent adverse event. Ten patients reported a serious adverse event; most were infection-related, the company said.

Zynerba said eight patients discontinued the study, one due to an application site reaction and others due to withdrawal of consent or perceived lack of efficacy.

The Devon, Pa.-based pharmaceutical company's stock was down by 23.17% following the news to $8.68 as of 9:43 a.m. ET on Nasdaq.

Zynerba Chairman and CEO Armando Anido said the company plans to meet with the U.S. Food and Drug Administration in the first half of 2020 to discuss a clinical pathway to approval.