Fast migraine relief through an oral adhesive Migraine can have a debilitating impact on sufferers. Thanks to a European project, a drug-delivery film for fast eradication will soon be on the market. Health © Maridav, Shutterstock Migraine is a neurological condition with multiple recurring symptoms including nausea, throbbing headache and sensitivity to light. It severely disrupts the everyday life of sufferers, who are forced to take days off work and be less productive. Moreover, emerging evidence suggests an association with the development of neurodegenerative diseases later in life if migraine attacks are not managed. A drug-delivery film the size of a postage stamp Conventional anti-migraine drugs in the form of pills achieve oral delivery through the stomach, with very little of the drug reaching the bloodstream. The EU-funded RAPID project has generated a novel film that delivers the drug through the oral mucous membrane. “Our film can be discreetly attached to the inside of the cheek, delivering the drug much more quickly than swallowed tablets or capsules,” explains Scott Boyer, project coordinator and chief scientific officer at Klaria AB. The RAPID team has selected sumatriptan, one of the most proven migraine medications available today. It acts to contract the blood vessels surrounding the brain that are known to expand during a migraine attack. Clinical evidence over the past two decades indicates that sumatriptan can help tackle migraine if administered promptly. RAPID’s film formulation is robust and portable, in packaging the size of a business card. Sumatriptan is already in a dissolved state in the film, and so is readily released into the bloodstream. Contrary to self-administered nasal sprays, the film achieves consistent drug delivery with minimal between-patient variability. And importantly, it is suitable for patients suffering from nausea and vomiting. Improved film performance and broad patient group The film formulated and manufactured by RAPID performs in an equivalent manner to existing sumatriptan nasal sprays with respect to the rate and extent of absorption of sumatriptan. The team successfully scaled up quality-controlled manufacturing of the clinical doses required for the study. “Importantly, we completed the drug testing trial in the middle of the COVID-19 pandemic without significant patient drop-out,” emphasises Boyer. Migraine sufferers commonly feel a lack of control over the symptoms and the enormous disruption they cause in their daily lives. The RAPID film has been designed not only to address the migraine attack itself in a more consistent and effective way, but also to return an essential sense of control to these patients. Although stress, hormonal changes and hypersensitivity to certain foods may act as migraine triggers, the actual cause of migraines remains elusive. Likewise, we don’t understand why women aged between 25 and 45 suffer more from migraine than men, and also have more intense co-morbidities. The RAPID film aims to overcome migraine-associated incapacitation in this particular group of sufferers, who often shoulder numerous responsibilities and cannot afford to be inactive for large periods of time. Moreover, the film is suitable for paediatric migraine patients and can be loaded with drug doses tailored to children. Its compact and robust nature, alongside its consistent drug delivery, offer parents, caregivers and sufferers a valuable tool in mitigating the negative effects of migraine. Keywords RAPID, migraine, film, drug, sumatriptan, oral mucous membrane
