Zelira Therapeutics Ltd. has received the final clinical report for its Phase 1 dose escalation trial in chronic pain patients on long-term high-dose opioid treatment. Zelira is pleased to confirm the trial successfully met its primary and secondary endpoints for safety and efficacy. The study was undertaken at the St Vincent's Hospital in Melbourne in conjunction with Emerald Clinics Ltd. in Perth who were engaged as a second site. The trial was led by coordinating principal investigator Associate Professor Yvonne Bonomo for St Vincents and Associate Professor Alistair Vickery for Emerald Clinics. The phase 1 dose-escalation trial was designed to assess the safety of Zelira's cannabis formulation (ZTL-103) in chronic pain patients already on long-term high-dose opioid treatment. Nine patients were enrolled and seven patients completed the study. The mean age was 58 years and mean oral Morphine Equivalent Daily Dose (oMEDD) was 93mg per day. Participants had a range of physical comorbidities and polypharmacy. Patients were treated with a single sublingual dose of ZTL-103 containing 5 mg of total cannabinoids (2.5 mg THC and 2.5 mg CBD) on the first day. After a seven day washout they received another single dose of ZTL-103 containing 5 mg of total cannabinoids at the same time as having a high fat meal. Patients then continued to take two daily doses of 5mg of total cannabinoids for seven days, before escalating to 20 mg total cannabinoids per day for seven days and then up to 30 mg total cannabinoids for a further seven days before taking a single dose of 25 mg total cannabinoids. Patients then underwent a 7 day washout period before returning for the final study visit.