Cefaly, a non-invasive device that claims to be able to treat up to 75 per cent of people suffering from frequent migraine attacks, received clearance from the UK’s National Institute for Health and Care Excellence in May. We speak to Dr Pierre Rigaux, one of its inventors, and Bharat Vadukul from its UK distributor, about the development of this almost side-effect-free migraine treatment
From trepanning in prehistoric times to painkillers today, migraine treatments have sought to alleviate the misery and pain of the condition, but a universal cure and cause has yet to be found. Research suggests that migraines affect one in seven people worldwide, and that there are 190,000-plus attacks every day in the UK alone, with more than half of sufferers experiencing severe impairment. Migraine takes its toll not only on our health but also on the economy, with 25 million lost work/school days and a £150-million NHS bill for prescription drugs and GP visits each year.
Available in the UK since 2014, Cefaly is a battery-powered headband that passes mild electrical impulses via an electrode on the forehead to stimulate the trigeminal nerve (where migraines are believed to originate). Worn for 20 minutes a day – or at the first sign of pain – if used correctly, the migraine treatment has been shown to reduce the severity and frequency of attacks in seven out of ten patients.
Electricity as a treatment for pain relief isn’t new. In fact it’s very old. The ancient Roman court physician, Scribonius Largus, who used electric eels to treat gout and headaches, was an early proponent. More recently, TENS (Transcutaneous electrical nerve stimulation) machines have been used to treat various types of pain since the mid-1970s. But Cefaly is the first compact trigeminal neurostimulation device on the market for the treatment and the prevention of migraines.
Several published studies have demonstrated the clinical effectiveness and safety of the migraine treatment – Cefaly is CE marked and is an ISO-certified medical device. Trials have also revealed that, unlike most migraine medications, the device comes with few side effects and can even be used during pregnancy. In a survey of more than 2,000 users, only 4 per cent of patients reported any side effects.
The inspiration for Cefaly came from a 2001 clinical study on the use implanted neurostimulation devices to treat migraine, explains its co-creator and CEO of Belgian company Cefaly Technology, Dr Pierre Rigaux, ‘But with an invasive treatment, there were issues such as infection, battery problems, broken electrodes, etc. My colleague Pierre-Yves Muller and I thought that neuromodulation could be very useful if it could be carried out externally.
‘We started work on the Cefaly in 2003, and the device made it to market in Europe in just five years,’ Rigaux explain. ‘Both myself and Pierre-Yves were already involved in the neuromodulation field – mainly using the technique on the body rather than the head – so we started with a high level of knowledge.’
The development process wasn’t without its challenges – technical and regulatory. ‘When you apply electricity externally to the head, you don’t want it to be painful. You want to reach the optimum level of electronic impulse to stimulate the cranial nerve, and that took a number of iterations,’ Rigaux explains. ‘We also had to create an electronic device that was portable, light and easy for people to use at home themselves.’ The device’s development was funded by bank loans, a grant from Belgium’s Wallone region and private money.
By 2008 Cefaly Technology had authorisation to sell its migraine treatment in Europe – and had devised launch strategies for countries such as France, Germany, Canada and Italy, as well as for setting up Cefaly representation partnerships in neurology and pain clinics in various countries. Rigaux continues: ‘However, as the biggest market for neuromodulation, the US was our main target. So between 2008 and 2011, we focused on running clinical trials in Belgium and the US to get sufficient good-quality clinical data to ensure approval from the US Food and Drugs Administration (FDA).’ A study of 67 non-medicating migraine patients showing that 40 per cent of those using Cefaly had experienced significantly fewer days with migraines per month, and another involving 2,300-plus users revealing that 53 per cent were satisfied with the device and would buy one, led the FDA to authorise the company to actively market Cefaly in the US in early 2014.
2014 continued to be a busy year for the company with the opening of a US office, the launch of Cefaly in Saudi Arabia, Brazil and Scandinavia, as well as setting up distribution deals in Taiwan and extending those in Denmark and the UK. There were also plans afoot to launch in South Korea, the Philippines, Greece and China the following year.
2014 was also the year that point-of-care diagnostics distributor BHR Pharmaceuticals became the company’s main UK distributor. Bharat Vadukul, BHR’s Manager, explains. ‘We proposed two key actions: firstly, that we seek a NICE guidance from the NHS and secondly, that we should try and get Drug Tariff application (DTA), so the product could be available on prescription.’
In May this year, the UK’s National Institute of Health and Care Excellence (NICE) issued full guidance on Cefaly, meaning that the device’s clinical data and safety evidence has been thoroughly reviewed by NHS experts. ‘The guidance enables doctors in the UK to recommend the device for the first time, although each NHS trust can decide whether to fund the device or require patients to buy it themselves,’ explains Vadukul. ‘However, we will be carrying out more research, as NICE has indicated that further studies are needed because some of the earlier ones were so small.’ The company will also be working towards obtaining more solid and robust medical data to get its DTA, which might take many months to acquire.
With distribution in 25 countries and 150,000 devices sold worldwide since the launch, what’s next in the pipeline for Cefaly? ‘Having developed the neuromodulation technology to treat migraine, we are now investigating its use in treating other neurological diseases such as fibromyalgia, post-concussion syndrome, cluster headaches, and even coma and insomnia,’ explains Rigaux. For Vadukul, it’s about getting more migraine sufferers to use the product as a first-line therapy. ‘Currently, people are looking at drugs to treat migraine and then at alternatives. We have to show clinical utility and build up a picture to convince people that Cefaly should be their first choice, and that involves, guess what… more research!’
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