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- Tecfidera® (Dimethyl Fumarate) Prescribing Information and Patient Information.Biogen, 2020Accessed 22 June 2020)
Biogen. Vumerity® (diroximel fumarate) prescribing information and patient information, 2021. DailyMed - VUMERITY- diroximel fumarate capsule (nih.gov). Accessed 16 December 2021.
CDER US FDA. Clinical pharmacology and biopharmaceutics review(s). Application Number 211855Orig1s000. Rev_211855(2)_package_Redacted.pdf (fda.gov). Accessed 16 December 2021.
Food and Drug Administration: Center for Drug Evaluation and Research (CDER). Guidance for Industry: bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations (Draft March 2014). Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM389370.pdf. Accessed on 9 July 2020.
- Placebo controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.N. Engl. J. Med. 2012; 367: 1087-1097
- Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.N. Engl. J. Med. 2012; 367: 1098-1107
- Pharmacokinetics and bioavailability of monomethyl fumarate following a single oral dose of Bafiertam™ (monomethyl fumarate) or Tecfidera ® (dimethyl fumarate).CNS Drugs. 2021; 35 (MayEpub 2021 Mar 30): 567-574https://doi.org/10.1007/s40263-021-00799-9
- Improving the gastrointestinal tolerability of fumaric acid esters: early findings on gastrointestinal events with diroximel fumarate in patients with relapsing-remitting multiple sclerosis from the phase 3, open-label EVOLVE-MS-1 study.Adv. Ther. 2019; 36 (NovEpub 2019 Sep 19. PMID: 31538304; PMCID: PMC6822793): 3154-3165https://doi.org/10.1007/s12325-019-01085-3
☆This study has been registered with ClinicalTrials.gov (NCT05181215) on 6 January 2022.