Alkermes PLC has launched a Phase 3 study for its product ALKS 8700 – a novel, oral monomethyl fumarate (MMF) drug in development that will be used for patients with relapsing forms of multiple sclerosis.
“ALKS 8700, a MMF prodrug with distinct physical-chemical properties, is designed to provide therapeutic concentrations of MMF in the body and offer differentiated features as compared to the market leader dimethyl fumarate, TECFIDERA, which is associated with gastrointestinal side effects," Dr. Elliot Ehrich, chief medical officer of Alkermes, said in a statement. "These adverse events can lead to treatment interruption or discontinuation for patients with MS."
Ehrich noted that the company believes ALKS 8700 can be valuable for those suffering with MS; it would provide fumarate therapy’s efficacy but with more favorable gastrointestinal tolerability.
“This elective study for ALKS 8700 demonstrates Alkermes’ unique approach to fully characterize the potential value of new medicines, reflecting our commitment to integrating inputs from patients, physicians and payers into our development programs in response to an increasingly complex healthcare system,” Alkemes CEO Richard Pops said.
Alkermes plans to submit a New Drug Application to the U.S. Food and Drug Administration for ALKS 8700 in 2018.