Newest evidence for tetrahydrocannabinolcannabidiol oromucosal spray from postapproval pragmatic studies.
Postapproval studies have an essential role in demonstrating that an intervention is effective and well tolerated during use in daily clinical practice. Numerous large observational and registry studies of tetrahydrocannabinol (THC)cannabidiol (CBD) oromucosal spray have been conducted subsequent to its approval in Europe in 2011. Collectively, these studies provide valuable insight into various aspects of THCCBD spray during real-world use in patients with multiple sclerosis spasticity, including its long-term effectiveness and tolerability. The Italian Medicines Agencys web-based registry is the largest observational study of THCCBD oromucosal spray conducted to date, reporting on more than 1600 patients prescribed THCCBD spray since it was introduced in Italy in 2013, and further supporting its effectiveness and tolerability profile.