UK patients suffering from neurological problems linked with liver disease will now, for the first time, have access to a specifically approved treatment for their condition following the launch of Norgine Pharmaceuticals' and Alfa Wassermann's Targaxan 550 this week.
Hepatic encephalopathy can occur in patients with liver disease from the build up of serum toxic substances produced by gut bacteria that are not properly removed by the damaged organ, which then enter the brain and cause a range of neuropsychiatric disorders, from mild intellectual impairment to personality changes, depressed level of consciousness and even coma.
According to the companies, Targaxan 550 (rifaximin-alpha) is the only treatment available in the UK specifically licensed to reduce the recurrence of episodes of overt hepatic encephalopathy (HE) in patients aged 18 years and over, following the regulatory seal of approval in Europe towards the end of last year.
The drug, which was developed by Alfa Wassermann, is a gut specific antibiotic which targets Gram positive and Gram negative ammonia producing bacteria to reduce the amount of ammonia and other compounds believed to be important in the development of HE.
Marketing clearance was based on data from a pivotal trial in which patients in remission from recurrent episodes of HE due to liver cirrhosis were either treated with Targaxan 550 twice-daily or a placebo (bd) over six months.
Findings showed a 58% relative reduction in the risk of breakthrough episodes of overt HE and a 50% relative reduction in the risk of hospitalisations caused by the condition over the period, thereby also offering a potential cost saving to the NHS.
Improved health and quality of life?
To date, the standard treatment of patients with HE has been very large doses of laxatives, and so the availability of a new treatment "that alleviates the symptoms of encephalopathy and does not have the severe side effects that current treatment has is going to have huge benefit to the health and quality of life of both the patients and their families,” commented Andrew Burroughs, Consultant Physician and Professor of Hepatology at the Royal Free Hospital London.
Bob Cuffe, UK General Manager for Norgine, also said that Targaxan 550 "has the potential to change the way in which UK patients with this debilitating condition are managed".
Targaxan 550 carried an NHS price tag of £259.23 for a month’s supply of 56 tablets.