Abstracts

Rationale: Evaluate the long-term safety and efficacy of ZYN002 (transdermal cannabidiol [CBD] gel) as adjunctive therapy for the treatment of focal seizures in adults. Methods: STAR 2 is the open-label extension study for completers of the 12-week STAR 1 study.  In STAR 2, all patients start on 390 mg transdermal CBD daily and are permitted to titrate up to 585 and 780 mg daily or down to 195 mg daily. Results: Of the 174 patients who completed STAR 1, 171 patients rolled into STAR 2.  STAR 1 showed only a beneficial trend for ZYN002, but did not show a significant effect.  As of May 21, 2018, 76 patients have completed the first 12 months of therapy in STAR 2.  Seizure control was evaluated as a function of duration on ZYN002.  On a group basis, seizure frequency reduced over time, with median percent change in seizures from -25% at 3 months (n=171), to -36% at 6 months (n=146), -49% at 9 months (n=112), and -58.0% at 12 months (n=70) in STAR 2. ZYN002 was well tolerated, with favorable skin tolerability.  The most common adverse events were upper respiratory tract infection (viral and bacterial; 16%), headache (11%), fatigue (7%), and laceration (5%). Conclusions: Seizure control appeared to improve in cohorts who continued with ZYN002 in STAR 2, with clinically meaningful reductions observed by 3 months of treatment. Patients maintained seizure control through 12 months in STAR 2. Results out to 18 months in STAR 2 (all patients and the cohort of patients who remain in the study) and seizure control with higher ZYN002 doses (585 mg and 780 mg) will be presented. ZYN002 (administered BID) was well tolerated, with excellent patient compliance and acceptance. These data support further evaluation of ZYN002 in double blind studies. Funding: This study was funded by Zynerba Pharmaceuticals, Inc.