Long-term effectiveness and safety of medical cannabis administered through the metered-dose Syqe Inhaler

Abstract

Abstract. Introduction:. Preliminary clinical studies on medical cannabis (MC) treatment using the Syqe Inhaler showed short-term effectiveness and safety at very low and precise doses of MC. Objectives:. Here, we retrospectively analyzed “real-life” long-term data collected in real time on the potential effectiveness and safety of MC administered with this device. Methods:. Patients were monitored by Syqe's patient support program. (−)-Δ9-trans-Tetrahydrocannabinol (Δ9-THC) served as a dosage marker for full-spectrum MC. Pain intensity was evaluated using a numeric pain scale (NPS) from baseline to 120 days after treatment initiation. The change in quality of life (QoL) from baseline was evaluated. Adverse events (AEs) were followed up continuously for 15 months. Results:. Of the 143 patients (mean age 62 ± 17 years; 54% males) included in the analysis, most (72%) were diagnosed with chronic neuropathic pain. The stable daily dose, after a mean 26 ± 10 days of titration was 1,500 ± 688 μg aerosolized Δ9-THC. Significant pain reduction, ranging from 22.8% in the intent-to-treat population to 28.4% in the population that reported baseline pain intensity ≥8 points on the NPS (P < 0.001), was observed. Ninety-two percent of patients reported improved QoL. Adverse events were reported mostly during the titration phase (34% of patients) and declined to ≤4% at 3 to 15 months. Only 7% of patients reported psychoactive AEs (anxiety and restlessness). Conclusions:. Medical cannabis treatment with the Syqe Inhaler demonstrated overall long-term pain reduction, QoL improvement, and a superior AE profile compared with administration of MC by conventional routes. Additional follow-up in a larger population is warranted.