GW - Spasticity and Post-Traumatic Stress Disorder PTSD Treatment
From Healthcare Professionals - Research & Trials - Therapeutic Areas
Our proprietary complex botanical mixture, called nabiximols (Sativex® outside of the U.S.) is an oromucosal spray of a formulated cannabis extract that contains the principal cannabinoids delta-9-tetrahydrocannibinol (THC) and cannabidiol (CBD) as well as specific minor cannabinoids and other non-cannabinoid components. GW developed nabiximols to be administered as an oromucosal spray, whereby the active ingredients are absorbed in the lining of the mouth, either under the tongue or inside the cheek. Regulatory approval has been obtained in numerous countries outside the United States for the treatment of spasticity (muscle stiffness/spasm) due to MS.*
Details
GW is now progressing a development program of nabiximols in the U.S. for the treatment of spasticity due to multiple sclerosis and Spinal Cord Injury and for patients suffering from PTSD. GW has commenced a pivotal program in the U.S. designed to bridge from the previously conducted trials in Europe with the goal of submitting a New Drug Application (NDA) with the FDA for these indications. Importantly, other elements necessary for an NDA submission are largely in place. For example, we have nearly 100,000 patient years of safety data, as well as a regulatory-approved, commercial scale manufacturing process that has been in place for many years.
GW believes that there could be the potential for application for the broader spasticity market beyond multiple sclerosis and spinal cord injury as there are around three million patients in the United States with spasticity associated with various conditions.
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