Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 11, 2017
electroCore Announces Results from gammaCore(R) (non-invasive vagus nerve stimulator) Study in Migraine at the 18th Congress of the International Headache SocietyPRESTO demonstrates clinical benefit of gammaCore in the acute treatment of migraine compared to sham
BASKING RIDGE, N.J., Sept. 11, 2017 -- (Healthcare Sales & Marketing Network) -- electroCore, a neuroscience and technology company dedicated to improving patient outcomes through technological advancement, announced the first results from the PRESTO (The PRospectivE Study of nVNS for the Acute Treatment Of Migraine) clinical trial evaluating the use of gammaCore® (non-invasive vagus nerve stimulator) in migraine at the 18th Congress of the International Headache Society (IHC). Findings from the study "Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Migraine: A Randomized Controlled Trial" (IHC Abstract OC-LB-002) were presented on Saturday, September 9 as a late-breaking oral presentation.
"Migraine is the third most common disease in the world,i and one of the 10 most disabling diseases, which highlights a need for novel treatment options," said Dr. Cristina Tassorelli, Director of the Headache Science Centre, National Neurological Institute C. Mondino Foundation; Professor at the University of Pavia, Pavia, Italy; and principal trial investigator. "The PRESTO data suggests that gammaCore was rapidly effective, well tolerated and practical for the acute treatment of episodic migraine. The data supports the use of gammaCore to successfully treat a migraine, making the device a potentially valuable treatment for the millions of people who suffer from migraine." gammaCore is CE-marked in the EU, which includes Dr. Tassorelli's practice, for the treatment of primary headache, which includes migraine headaches. The PRESTO data supports continued use of gammaCore in such countries for the treatment of migraine headaches. The data from PRESTO will be used to support the U.S. Food and Drug Administration (FDA) submission of gammaCore in the acute treatment of migraine, anticipated in Fall 2017.
Results from PRESTO were clinically significant. The multicenter, double-blind, randomized, sham-controlled trial evaluated the efficacy, safety and tolerability of nVNS in 243 patients with episodic migraine. 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 (primary endpoint) narrowly missed significance (30.4% vs 19.7%; P=0.067). A post hoc repeated-measures test was performed to examine the inconsistency between the 120-minute findings and the 30- and 60-minute findings. This test confirmed that gammaCore was superior to sham through 120 minutes (odds ratio: 2.3; 95% CI: 1.2, 4.4; P=0.012). The benefits seen with gammaCore were also observed in the secondary endpoints of pain relief at 120 minutes (40.8% vs 27.6%; P=0.030) and mean percent pain reduction (34.8% vs 5.4%; P=0.004). As seen in other published studies, gammaCore was again well tolerated, as demonstrated by a low incidence of adverse effects.
Additional electroCore data at the Congress includes:
Non-invasive Vagus Nerve Stimulation for the Acute Treatment of Episodic and Chronic Cluster Headache: Findings From the Randomized, Double-blind, Sham-Controlled ACT2 Study – Saturday, September 9 (IHC abstract OC-MC-003, Oral Presentation)
Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Migraine Without Aura in Adolescents: Preliminary Clinical Experience – Saturday, September 9 (IHC abstract PO-02-086, Poster and Brief Oral Presentation)
Non-invasive Vagus Nerve Stimulation for Acute Treatment of Episodic and Chronic Cluster Headache: Pooled Analysis of Data From Two Randomized, Double-blind, Sham-Controlled Clinical Trials – Saturday, September 9 (IHC abstract EP-02-005, Poster)
Peripheral Vagus Nerve Stimulation Modulates the Nociceptive Withdrawal Reflex in Healthy Subjects: A Cross-Over Placebo-Controlled Study – Friday, September 8 (PO-01-029, Poster)
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. They may occur with or without recognized warning signs, including either prodromal symptoms or an aura phase. Prodromal symptoms consist of altered mood, irritability, depression or euphoria, fatigue, dizziness and other visceral symptoms preceding the headache by several hours or days. Auras can include visual disturbances such as photopsia or scotomas or, in less frequent cases, somatosensory, auditory or gustatory hallucinations.
There are an estimated 21 million patients diagnosed with migraine in the U.S. every year, with more than 100,000 migraines occurring every day. Migraine prevalence is significantly higher in females than in males, at a ratio of 3:1.
gammaCore® (nVNS) is the first non-invasive, hand-held medical device applied at the neck that acutely treats the pain associated with episodic cluster headache in adult patients through the transmission of a mild electrical stimulation to the vagus nerve through the skin to activate the vagus nerve, resulting in the reduction of pain. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with standard of care. When placed on a patient's neck over the vagus nerve, gammaCore stimulates the nerve's afferent fibers, which may lead to a reduction of pain in patients.
gammaCore was released/cleared in the U.S. this past April for the acute treatment of pain associated with episodic cluster headache in adult patients. gammaCore is currently in use outside of the U.S., including in the European Union, where it is CE-Marked for these and other conditions.
IMPORTANT SAFETY INFORMATION REGARDING GAMMACORE
The safety and effectiveness of the gammaCore non-invasive vagus nerve stimulator has not been established in the acute treatment of chronic cluster headache.
This device has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache.
The long-term effects of the chronic use of the device have not been evaluated.
Safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore is NOT indicated for:
Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Patients should not use gammaCore if they:
Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
Are using another device at the same time (e.g., TENS unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Note: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.
electroCore, LLC is a U.S.-based neuroscience and technology company dedicated to improving patient outcomes through technological advancement and focused on developing non-invasive vagus nerve stimulation therapy for the treatment of multiple conditions in neurology, inflammation, and metabolic syndrome. The company's initial target is the treatment of primary headaches (migraine and cluster headache) and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders that drive disproportionately large direct and indirect costs within the healthcare system and society.
For more information, visit electrocore.comhttp://www.electrocore.com/.
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