Migraine treatment in Spain has taken a significant step forward with the launch of Nerivio®, a non-pharmacological device designed to alleviate migraine symptoms. This innovative product is being introduced to the Spanish market by Reddy Pharma Iberia SA, a subsidiary of Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company. Dr. Reddy’s had previously launched Nerivio® in Germany in March 2024 through its subsidiary Betapharm.
Nerivio® is a pioneering, portable Remote Electrical Neuromodulation (NER) device that has been cleared by the Food and Drug Administration (FDA) and received CE marking for the prevention and treatment of acute migraine, with or without aura, in both adults and adolescents aged 12 and older. This device is worn on the upper arm and controlled via a mobile app, making it a discreet and user-friendly solution for migraine sufferers. The device is set to be launched in the United Kingdom next June.
Dr. Reddy’s Laboratories announced the launch of Nerivio® in Spain on May 24, 2024. This device represents a significant advancement in the field of migraine treatment, offering a drug-free alternative for managing this debilitating condition. With migraine being the sixth most prevalent pathology globally and the second leading cause of disability, the need for effective treatments is paramount. In Spain alone, over 5 million people suffer from migraines, with women constituting 80% of this population. The economic burden is substantial, with annual costs per patient reaching €12,970 for chronic migraine and €5,041 for episodic migraine.
Innovative Neuromodulation Device Revolutionizes Migraine Treatment
Nerivio® operates through a novel mechanism of action. It utilizes Remote Electrical Neuromodulation (NER) to activate conditioned pain modulation (CPM) by stimulating nociceptive nerve receptors under the skin of the arm. This triggers a natural pain-relieving process in the brain stem, resulting in an overall pain-inhibiting effect. The device is intended for both acute and prophylactic treatment, providing relief by reducing the frequency and severity of migraine attacks.
Dr. Patricia Pozo Rosich, head of the Headache Unit at Vall d’Hebron University Hospital in Barcelona, praised the device, stating, “Neuromodulation is a significant advance in the treatment of migraine. For decades, medication has been the mainstay of migraine treatment. However, with these medications, many patients experience side effects or limited effectiveness. Neuromodulation technologies offer a necessary alternative that can also be complementary to pharmacological treatments.” Dr. Pozo Rosich emphasized the benefits of Nerivio® for patients who prefer to avoid pharmacological treatments, such as adolescents and women of childbearing age planning a pregnancy.
Massimo Farioli, CEO of Dr. Reddy’s subsidiaries in Spain, Italy, and France, highlighted the company’s commitment to addressing the unmet needs of migraine patients. “Bringing Nerivio® to migraine patients in Spain underlines our commitment to meeting their unmet needs. The innovative drug-free treatment has the potential to improve the quality of life of migraine patients. It is a comfortable, discreet, and portable device that allows patients to focus on their daily activities more freely while wearing it, responding to the clinical need to offer a treatment with a significant impact on well-being and quality of life.”
Clinical Trials Confirm Nerivio® as Effective Drug-Free Migraine Treatment
Clinical trials have demonstrated the effectiveness of Nerivio® in treating migraine. It has proven to be a suitable alternative for a wide range of migraine patients, particularly those seeking drug-free therapy or those unable to control their migraine with medications. The device is especially beneficial for sensitive populations, including adolescents, women of childbearing age, and patients at risk of medication overuse. Studies have shown that Nerivio® does not cause systemic side effects or excessive use issues and effectively relieves not only pain but also symptoms such as nausea, vomiting, phonophobia, and photophobia.
In August 2023, Nerivio® received expanded CE Mark approval under the European MDR regulation as a dual-use treatment for migraine in adolescents and adults. The launch in Spain is part of a series of agreements between Dr. Reddy’s European subsidiaries and Theranica for the marketing and distribution of Nerivio® across multiple European countries. Nerivio® requires a prescription and is indicated for the acute and/or preventive treatment of migraine with or without aura in patients aged 12 and older. Patients are advised to consult with their physicians or neurologists regarding the use of the device and migraine treatment.
Dr. Reddy’s Laboratories Ltd. is a multinational pharmaceutical company headquartered in Hyderabad, India. Founded in 1984, the company is dedicated to accelerating access to innovative and affordable medicines. Dr. Reddy’s offers a portfolio of products and services, including APIs, generics, branded generics, biosimilars, and OTC. Their primary therapeutic areas are gastrointestinal, cardiovascular, diabetes, oncology, pain treatment, and dermatology. The company’s main markets include the United States, India, Russia, and the CIS countries, China, Brazil, and Europe. Dr. Reddy’s is committed to sustainability and ESG actions, continuously planning and investing in future businesses while prioritizing environmental stewardship, patient access, affordability, diversity, and governance.
Resource: Businesswire, May 24, 2024
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