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NICE backs Allergan's IBS therapy Truberzi

The £3 per day therapy was recommended in final guidance from the cost-effectiveness watchdog

AllerganNICE has recommended routine NHS funding for Allergan's Truberzi, which is the first drug for irritable bowel syndrome with diarrhoea (IBS-D) to pass through its review process.

Final guidance issued by the clinical and cost-effectiveness watchdog says the £3 per day therapy should be made available for IBS-D patients who have not responded to or cannot take other treatments.

Truberzi (eluxadoline) is the only drug licensed for IBS-D in Europe and was approved by the EMA last year based on data from two pivotal trials which revealed the drug achieved a significant improvement in two key symptoms of IBS-D - abdominal pain and diarrhoea - with relief coming in as little as a week and sustained over six months.

Eluxadoline works by stimulating to mu and kappa opioid receptors in the digestive system, and blocking delta opioid receptors, which has the effect of slowing down the movement of food through the gut. This helps to relieve associated stomach cramps and the urgency for a person to go to the toilet, according to NICE.

It is estimated that between 10-20% of the UK general population has IBS, and out of those around a third have IBS-D.

"Until now doctors have had limited options when it comes to treating IBS-D and unfortunately this has been to the detriment of patients, many of whom endure debilitating symptoms on a daily basis," said Dr Adam Farmer, consultant gastroenterologist at University Hospitals of North Midlands and scientific advisor at UK charity The IBS Network.

"For doctors to now be able to prescribe Truberzi, a targeted treatment, this will signify real change for IBS-D sufferers," he added.

NICE says Truberzi will be available for patients alongside existing drug and psychological treatments for IBS-D, such as drugs that stop spasms in the gut or hypnotherapy. It has also said Truberzi should only be offered in secondary care and must be discontinued after four weeks if the treatment is not working.

The green light from NICE is good news for Allergan, which sees Truberzi - known as Viberzi in the US - as a key component of its emerging gastrointestinal product franchise, which also includes Linzess (linaclotide) for IBS with constipation.

Viberzi sales in the US were almost $73m in the first six months of the year, almost a three-fold increase over the same period a year earlier, while Linzess contributed $315m, up 10%. Analysts have suggested sales of Viberzi/Truberzi could reach $450m by 2020.

Article by
Phil Taylor

1st September 2017

From: Regulatory

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