Authors' objectives
Cerenday (biotin) is a high dose oral formulation of biotin, a water soluble vitamin that acts as a coenzyme for carboxylases involved in key steps of energy metabolism and fatty acid synthesis. Very high doses of biotin may be efficacious in multiple sclerosis (MS) by promoting myelin repair through activation of acetyl-CoA carboxylase, and by enhancing energy production in demyelinated neurons through activation of the tricarboxylic acid (Kreb's) cycle. Biotin is intended for the treatment of primary and secondary progressive MS and is administered orally at 100mg three times daily for up to 24 months.
MS is a chronic immune-mediated condition of the central nervous system characterised by demyelination and axonal degeneration. Resultant damage leads to a wide spectrum of symptoms and signs, potentially including difficulties with weakness, sensory disturbance, balance and vision. The prevalence of MS in England is approximately 0.16%, equivalent to approximately 85,600 affected people. Primary progressive multiple sclerosis (PPMS) affects about 10-15% of people diagnosed with MS, which equates to between 8,560 and 12,840 patients in England. Approximately 35.5% of patients diagnosed with MS have relapsing-remitting disease. This equates to around 30,388 people in England. However, after two decades, more than half of patients who suffer from relapsing-remitting multiple sclerosis (RRMS) enter a secondary progressive phase. In 2013-14 there were 44,335 admissions for MS in England, resulting in 53,554 bed days and 46,584 finished consultant episodes. In England and Wales, 1,100 deaths due to MS were registered in 2013.
Biotin is currently in two phase III clinical trials assessing its effect compared with placebo on disability and visual acuity respectively. Both trials are expected to be complete by March 2016.
Address for correspondence
NIHR Horizon Scanning Research&Intelligence Centre, University of Birmingham, Institute of Applied Health Research, Public Health building, Edgbaston, Birmingham B15 2TT
Tel: 0121 414 9077 Email: nihrhsc@contacts.bham.ac.uk