Zynerba Pharmaceuticals is reporting new longer term open label clinical data today in the Emerging Science session of the 2018 Annual Meeting of the American Academy of Neurology in Los Angeles, CA. In a poster presentation entitled, "Transdermal Cannabidiol Gel for the Treatment of Focal Epilepsy in Adults", Dr. John Messenheimer presents additional data from ongoing STAR 2 24-month open label extension study evaluating ZYN002 cannabidiol transdermal gel in adult patients with focal seizures. The presentation includes data through twelve months of open label exposure to ZYN002. The key findings include that responses to ZYN002 in the STAR 2 open label extension, as measured by reductions in focal seizures from the baseline period of STAR 1, are associated with continued treatment with ZYN002. In addition, ZYN002 was shown to be well tolerated through 12 months of treatment in STAR 2. The data presented in the poster are as follows:188 patients were randomized, 186 were analyzed for efficacy, and 174 completed STAR 1; 171 patients continued into STAR 2; As of December 12, 2017, 95 patients remained in the STAR 2 study; Patients were taking a wide range of antiepileptic drugs, the most common of which are levetiracetam, carbamazepine, lamotrigine, lacosamide, and valproate. In STAR 2, longer term exposure to ZYN002 resulted in greater improvements in seizure frequency among all ZYN002-treated patients; Longer term exposure to ZYN002 appeared to result in clinically meaningful reductions in seizures both across and within originally randomized STAR 1 patient groups:Compared to baseline, the median changes in seizure rates at months 3, 6, 9, and 12 of STAR 2 across all ZYN002-treated patients at each time point were: 25% reduction at month 3, 36% reduction at month 6, 49% reduction at month 9, 58% reduction at month 12. ZYN002 was well tolerated with good skin tolerability; In STAR 2, the most common treatment-emergent AEs were upper respiratory tract infection and headache. One serious AE was considered possibly related to ZYN002; There were no clinically significant abnormal liver AEs greater than3x upper limit of normal reported for patients receiving ZYN002.
