Mitsubishi Tanabe Pharma America (MTPA) will present initial data on efforts to create an oral version of edaravone, a key drug in the treatment of ALS that is currently only available intravenously, during the International Symposium on ALS/MND in Glasgow, Scotland. The symposium will be held Dec. 7-9. MTPA is expected to present results that demonstrate that oral edaravone is processed in the body in the same manner as the infused formulation.
An intravenous formulation of edaravone, Radicava, was approved by the U.S. Food and Drug Administration to treat ALS in May 2017.
“We are happy to learn that MTPA is working on an oral formulation of Radicava. This new formulation could make it easier for people living with ALS to take the drug. As we learn more, we will be sure to update our community,” stated Dr. Neil Thakur, executive vice president of mission strategy at The ALS Association.
The initial phase I study is expected to demonstrate that a single dose of oral edaravone has the same pharmacokinetic (PK) profile as the IV infusion. PK is a way to understand how a drug behaves in the body. This is important because is helps answers the questions of how a drug is absorbed, where does it go, how long it stays in the body, and how it is eliminated in the body.
The company also stated that there are no new safety findings observed with the oral formulation of edaravone in comparison to IV infused Radicava.
Read MTPA’s press release here.