gammaCore® riceve l’approvazione dell’FDA per il trattamento acuto del dolore associato alla cefalea emicranica nei pazienti adulti
Basking Ridge, NJ, 29 gennaio 2018 – electroCore, LLC (electroCore), a commercial-stage bioelectronic medicine company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded label for gammaCore® (nVNS) as an acute treatment of pain associated with migraine in adult patients. La terapia con gammaCore è un trattamento proprietario di neuromodulazione non invasiva somministrato mediante un’unità manuale che stimola il nervo vago attraverso la pelle. Questa espansione dell’etichetta è la prima per electroCore da quando gammaCore ha ricevuto la sua autorizzazione iniziale dell’FDA per il trattamento acuto del dolore associato alla cefalea a grappolo episodica nei pazienti adulti nel aprile 2017.
“Migraine is a debilitating disease affecting 39 million Americans, the majority of whom do not seek medical care for their pain.1 With the FDA’s decision to release gammaCore for migraine, patients now have access to an effective and safe therapy which can be self-administered to acutely treat the pain associated with migraine,” said Stephen D. Silberstein, M.D., Professor of Neurology and Director of the Headache Center, Thomas Jefferson University.
The FDA clearance of gammaCore for the acute treatment of pain associated with migraine was principally supported by the results of the multicenter, randomized, double-blind, sham- controlled trial, PRESTO (PRospectivE Study of nVNS for the Acute Treatment Of Migraine).2 Results from this trial, which were recently profiled at the Congress of the International Headache Society (IHC) in Vancouver in settembre 2017, demonstrated that treatment with gammaCore for the acute treatment of pain associated with migraine was superior to sham, and also enabled patients to reach pain freedom more frequently by 30, 60, and 120 minutes compared with sham treatment.2 The results further showed that a significantly higher proportion of gammaCore-treated patients achieved pain relief within two hours compared with the control treatment.2 Consistent with all prior studies with gammaCore, the therapy was found to be well tolerated by patients.2
“With annual healthcare and lost productivity costs associated with migraine measured in the tens of billions of dollars in the U.S., the availability of gammaCore provides patients with a new treatment option to relieve migraine pain, while also offering the potential to alleviate some of the economic strain that arises from their condition as well,” said Francis R. Amato, Chief Executive Officer of electroCore.
gammaCore is also available outside of the U.S., including in Canada and the European Economic Area. In the U.S., gammaCore is commercially available for the acute treatment of pain associated with episodic cluster headache in adults. electroCore expects commercial availability of gammaCore for the acute treatment of pain associated with migraine headache in adults in the second quarter of 2018.
The multicenter, randomized, double-blind, sham-controlled trial evaluated the efficacy, safety and tolerability of nVNS in 243 patients with episodic migraine. Results from PRESTO found that acute treatment with gammaCore was superior to sham for pain freedom at 30, 60, and 120 minutes: nVNS (n=120) led to significantly higher pain-free rates than sham (n=123) for the first treated migraine attack at 30 minutes (12,7% vs 4,2%; p=0.012) and 60 minutes (21,0% vs 10,0%; p=0.023); however, the improvement at 120 minutes missed statistical significance (30,4% vs 19,7%; p=0.067). A post-hoc repeated-measures test was performed to examine the statistical anomaly between the 120-minute findings and the 30- and 60-minute findings. Questa analisi ha confermato che gammaCore era superiore al placebo per tutti i 120 minuti (odds ratio: 2,3; IC al 95%: 1,2, 4,4; p=0.012). Clinically meaningful and statistically significant benefits from our gammaCore therapy were also observed in the secondary endpoints of mild or no pain at 120 minutes (40,8% vs 27,6%; p=0.030) and mean percent pain reduction at 120 minutes (34,8% vs 5,4%; p=0.004). As seen in other published studies, gammaCore was well tolerated, as demonstrated by a low incidence of device-related adverse effects.2
Informazioni su gammaCore®
gammaCore® (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck that acutely treats the pain associated with episodic cluster headache and migraine in adult patients through the utilization of a mild electrical stimulation to the vagus nerve that passe through the skin. Concepito quale strumento tecnologico portatile facile da usare, gammaCore può essere autosomministrato dai pazienti secondo necessità per dare sollievo, senza i potenziali effetti collaterali associati allo standard di cura. Quando posizionato sul collo di un paziente, sopra il nervo vago, gammaCore stimola le fibre afferenti del nervo e ciò può determinare una riduzione del dolore nei pazienti. gammaCore is released/cleared in the U.S. for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients. gammaCore is currently available outside of the U.S., including in the European Economic Area, where it is CE-Marked.
Migraine is a term used to describe a class of recurrent, pulsing headaches that are typically unilateral (on one side of the head) but may occur bilaterally (on both sides of the head) and may cause visual disturbances, nausea and vomiting.1 They may occur with or without recognized warning signs, including either prodromal symptoms or an aura phase.3 Prodromal symptoms consist of altered mood, irritability, depression or euphoria, fatigue, dizziness and other visceral symptoms preceding the headache by several hours or days.3 Auras can include visual disturbances such as photopsia or scotomas or, in less frequent cases, somatosensory, auditory or gustatory hallucinations.3
There are approximately 39 million Americans living with migraine, and more than 100.000 migraines occur every day in the U.S.1,4 Migraine prevalence is significantly higher in females than in males, at a ratio of 3:1.1
Informazioni su electroCore
electroCore, LLC is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology and rheumatology. The company’s initial targets are the acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
IMPORTANTI INFORMAZIONI DI SICUREZZA SU GAMMACORE
- The safety and effectiveness of the gammaCore (nVNS) has not been established in the acute treatment of chronic cluster headache.
- gammaCore has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache or migraine headache.
- The long-term effects of the chronic use of gammaCore have not been evaluated. La sicurezza e l’efficacia del dispositivo non sono state valutate nelle seguenti categorie di pazienti, pertanto, gammaCore NON è indicato per:
- Pazienti con un dispositivo medico impiantabile attivo, quale un pacemaker, una protesi acustica impiantabile o qualsiasi altro dispositivo elettronico impiantato
- Pazienti con diagnosi di stenosi arteriosa (aterosclerosi carotidea)
- Pazienti precedentemente sottoposti a intervento chirurgico di recisione del nervo vago a livello del collo (vagotomia cervicale)
- Pazienti pediatrici
- Donne incinte
- Pazienti affetti da ipertensione, ipotensione, bradicardia o tachicardia clinicamente significativa
- I pazienti non devono utilizzare gammaCore se:
- I portatori di un dispositivo metallico, quali stent, placche ossee o viti ossee impiantante in corrispondenza o in prossimità del collo
- Utilizzano contemporaneamente un altro dispositivo (ad es. unità TENS, stimolatore muscolare) o un qualsiasi dispositivo elettronico portatile (ad es. un cellulare)
Nota: questo elenco non è completo. Fate riferimento alle Istruzioni per l’uso di gammaCore per tutte le avvertenze e le precauzioni importanti prima di utilizzare o prescrivere questo prodotto.
gammaCore è disponibile esclusivamente su prescrizione. La legge federale degli Stati Uniti limita la vendita di questo dispositivo a o su prescrizione di un medico curante abilitato.
Contatto per i media
1Migraine facts. Migraine Research Foundation. http://migraineresearchfoundation.org/about-migraine/migraine- facts. Accessed gennaio 2018.
2Tassorelli, C., (settembre 2017). Non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a randomized controlled trial. Oral presentation at the Congress of the International Headache Society, Vancouver, Canada.
3Migraine and aura. American Migraine Foundation. https://americanmigrainefoundation.org/understanding- migraine/migraine-and-aura/. Accessed gennaio 2018.
4Global burden of migraine in the Year 2000: summary of methods and data sources. World Health Organization. http://www.who.int/healthinfo/statistics/bod_migraine.pdf. Accessed gennaio 2018.