Clinical experience with THCCBD oromucosal spray in patients with multiple sclerosis-related spasticity.
This detailed medical charts data collection study conducted at a multiple sclerosis (MS) clinic in Germany evaluated the effectiveness of tetrahydrocannabinol (THC)cannabidiol (CBD) oromucosal spray in patients with resistant MS spasticity. Over a 15-month timeframe, THCCBD spray was initiated in 166 patients. Mean follow-up was 9 months. In all, 120 patients remained on treatment for a response rate of 72%. THCCBD spray was used as add-on therapy in 95 patients and as monotherapy in 25 patients to achieve best-possible therapeutic results. Among responders, the mean spasticity 0-10 numerical rating scale (NRS) score decreased by 57%, from 7.0 before treatment to 3.0 within 10 days of starting THCCBD spray. The mean dosage was 4 spraysday. Most patients who withdrew from treatment (4046) had been receiving THCCBD spray for less than 60 days. Main reasons for treatment discontinuation were adverse drug reactions, mainly dizziness, fatigue and oral discomfort (23 patients 13.9%) lack of efficacy (14 patients 8.4%) or need for a baclofen pump (9 patients 5.4%). No new safety signals were noted with THCCBD spray during the evaluation period. In this routine clinical practice setting at an MS clinic in Germany, THCCBD spray was effective and well tolerated as add-on therapy or as monotherapy in a relevant proportion of patients with resistant MS spasticity.