Internis launches GI friendly alendronate formulation

PharmaTimes, May 20, 2016 — Internis Pharma Binosto is now widely available across the UK, offering patients with osteoporosis the chance to access the first buffered formulation of alendronate designed to minimise gastrointestinal side effects commonly linked with traditional versions of the drug.

The National Institute for Health and Clinical Excellence recommends alendronate as an option for the prevention of first fractures in a number of groups who have a high risk of fracture, as long-term treatment with the drug is known to improve bone mineral density (from 2.4 percent to 8.8 percent) and cut the risk of fracture (from 12 percent to 49 percent).

However, the side effects of the drug has led to poor compliance rates, with nine out of ten patients who are taking traditional form of alendronate having to drop therapy as a result. Eighty percent of patients come off treatment in the first year and over one in three fail to pick up a second indication, largely because of the gastrointestinal effects associated with bisphosphonates like alendronate.

Osteoporosis is estimated to affect more than three million people in the UK, most of whom are only aware they have it when they break a bone. Addressing poor adherence to treatment has been a key goal for some time, as it is estimated to result in a 37 percent higher risk of hospitalisation and a 17 percent higher risk of fracture, the firm notes.

Binosto’s novel, buffered alendronate formulation dissolves in water, helping to overcome the difficulties in swallowing pills that some patients experience and, crucially, as it increases pH levels in the stomach, thus minimising the gastrointestinal side effects commonly linked to these medicines, it has the potential to boost adherence.

The cost is £22.80 for four once-weekly tablets. This is a higher purchase price than a generic alendronate tablet but is lower than alternative treatments for patients who fail on alendronate (such as denosumab, etc). A spokesperson for the firm told PharmaTimes that Binosto should “save considerably on downstream costs”, given its potential to improve adherence and reduce the incidence of osteoporotic fracture, which costs the NHS around £5 million per day or £2 billion per year.

“I believe that, over time, data will show that Binosto’s novel alendronate formulation helps to improve the longterm tolerability of alendronate and helps to ensure that more women with osteoporosis are properly treated. This could result in fewer fractures, improved patient quality of life and lower overall costs,” said Dr Andrew Pearson, consultant radiologist, NHS Borders, commenting on its potential.

This impact will be more significant as our ageing population grows therefore, it is essential that patients have access to effective treatments that they are able to take over many years,” added Internis’ chief operating officer Paul Tredwell.

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