GW Pharmaceuticals hopes to bring its cannabis-based treatment for multiple sclerosis spasticity to the United States.
This morning, California-based GW said it will launch the first Phase III trial studying nabiximols, which is known as Sativex outside the United States, as a potential treatment for multiple sclerosis-associated spasticity. Sativex is approved for use in parts of Europe for this indication. The company is hoping to build on data accumulated from other late-stage studies conducted around the world, as well as approvals in more than 25 countries, in order to seek regulatory approval in America. Positive results from three previous European Phase III clinical studies show nabiximols was well-tolerated and provided continued reductions in patient-reported spasticity for individuals with MS, the company said.
Justin Gover, chief executive officer of GW Pharmaceuticals, proclaimed his excitement about launching the Phase III study in the United States. With strong data from previous global studies, as well as what he called “positive discussions” with the U.S. Food and Drug Administration, Gover said he believes there is a “clear path” to the submission of a New Drug Application as soon as 2021.
“Now is the ideal time to develop nabiximols in the U.S. as research shows a significant percentage of spasticity patients are today self-medicating using unapproved cannabis products to relieve their spasticity,” Gover said in a statement.
Published: November 03, 2020