Treatment with diroximel fumarate was associated with significantly fewer days of key gastrointestinal (GI) symptoms, according to topline results from a phase 3 study evaluating the GI tolerability of the agent in patients with relapsing-remitting multiple sclerosis (RRMS).   

In EVOLVE-MS-2, 506 patients with RRMS were randomized to receive either diroximel fumarate or dimethyl fumarate (Tecfidera; Biogen) for 5 weeks to evaluate the number of days patients reported GI events using the Individual Gastrointestinal Symptom and Impact Scale (IGISIS) with an intensity score ≥2 (primary end point).

Findings from the study showed that treatment with diroximel fumarate was found to be statistically superior to dimethyl fumarate, resulting in fewer self-reported days of GI symptoms (P =.0003). In the diroximel fumarate group, the proportion of patients that discontinued due to GI adverse events was 0.8% vs 4.8% of patients treated with dimethyl fumarate. Additional data from the trial will be presented at a future scientific meeting.

“These results reinforce the safety and tolerability profile diroximel fumarate has consistently demonstrated across the EVOLVE-MS development program, underscoring the potential importance of diroximel fumarate for the treatment of people living with relapsing-remitting MS,” said Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes. “We look forward to the FDA’s completion of its review of the diroximel fumarate NDA in the fourth quarter.” 

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Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body, the active metabolite of dimethyl fumarate. Due to its chemical properties, it has the potential for improved GI tolerability when compared with dimethyl fumarate. The NDA is supported by data from a phase 3, open-label, 2-year safety study (EVOLVE-MS-1) which showed that treatment with diroximel fumarate was associated with low rates of GI adverse events leading to discontinuation.

A Prescription Drug User Fee Act target date for the NDA has been set for the fourth quarter of 2019.

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