NEW YORK, Jan. 24, 2018 /PRNewswire/ -- The Cefaly® Acute medical device, cleared by the U.S. Food and Drug Administration (FDA) two months ago for the acute treatment of migraine with or without aura, was also successful in a recent trial for migraine abortion; and predominantly outperformed published data on triptans as well as medical drugs currently under investigation for the acute treatment of migraine.
Previous pilot and pivotal trials (ACME1) demonstrated the efficacy and safety of the Cefaly® Acute for the acute treatment of migraine attacks and led to the FDA approval. The new trial on migraine abortion was identical to the design used to test abortive migraine medication, including medications already on the market (triptans) and the new drugs still under medical investigation: Lasmiditan, Ubrogepant and Rimegepant.
The outcome at 2-hours of using Cefaly® Acute showed that 70.8% of patients had pain relief, 35.4% were pain-free, and 60.4% were free from the most bothersome symptom (MBS). In comparison, available data on Lasmiditan2 shows 59% of patients had pain relief at 2-hours, 32.2% were pain free and 40.9% were MBS-free; for Ubrogepant3 pain relief at 2-hours was 58.8%, while 25.5% of patients were pain free; and for Rimegepant4 at 2-hours pain relief was at 61.2%, with 32.9% of patients pain free. At the 24-hour mark, sustained pain freedom with Cefaly® Acute was 25% of patients. In contrast, Ubrogepant showed 21.6%, while Rimegepant demonstrated 28.2%.
Based on these encouraging positive results CEFALY Technology is now moving forward with a Phase 3 clinical trial in the US that is scheduled to be completed by the end of the year.
Usual acute treatment for migraine attacks are triptans but these medications have several important shortcomings: a significant number of migraineurs are unresponsive to triptans; they are contraindicated for patients having cardiovascular problems; they can cause significant side effects; and excessive triptan intake leads to medication overuse headache, a major cause of migraine chronification.
"We've made huge technical advances in recent years that have led to new device generations that are much more efficient than before. Recent improvements led to the Cefaly® Acute and now the new clinical data shows that it offers the best solution for the abortive treatment of migraine," said Dr. Pierre Rigaux, the chief executive officer of CEFALY Technology. "We are very excited by these results and eager to begin Phase 3 to provide full evidence that Cefaly® Acute as the first line abortive migraine therapy offers better efficacy than the triptans, fulfilling patients' unmet needs, and having next-to-no side effects, while remaining the cheapest overall treatment."
About MigraineMigraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation5. An estimated 39 million Americans suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $36 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) expenses each year in the United States.
About CEFALY TechnologyCEFALY Technology is a Belgium-based company, with US offices based in Wilton, Connecticut, specializing in electronics for medical applications. It has developed external cranial stimulation technology for applications in the field of neurology; in particular for treating migraines. For more information, visit http://www.cefaly.us. Find Cefaly on Twitter: @Cefaly and on Facebook: http://www.facebook.com/CefalyEN.
1 Acute Treatment of Migraine With e-TNS (ACME). U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT02590939. September 13, 2017
2 CoLucid Pharmaceuticals press release. CoLucid Pharmaceuticals, Inc. https://globenewswire.com/news-release/2016/09/06/869611/0/en/CoLucid-Pharmaceuticals-Announces-Achievement-of-Both-Primary-and-Key-Secondary-Endpoints-in-the-SAMURAI-Phase-3-Pivotal-Trial-of-Lasmiditan-in-Migraine.html. September 6, 2016.
3 A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. National Center for Biotechnology Information, U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/pubmed/27269043. June 6, 2016.
4 BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. National Center for Biotechnology Information, U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/pubmed/23965396. August 21, 2013.
5 Migraine facts. Migraine Research Foundation website. http://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed January 23, 2018.
Media Contact: Maria Coder[email protected]
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Previous pilot and pivotal trials (ACME1) demonstrated the efficacy and safety of the Cefaly® Acute for the acute treatment of migraine attacks and led to the FDA approval. The new trial on migraine abortion was identical to the design used to test abortive migraine medication, including medications already on the market (triptans) and the new drugs still under medical investigation: Lasmiditan, Ubrogepant and Rimegepant.
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The outcome at 2-hours of using Cefaly® Acute showed that 70.8% of patients had pain relief, 35.4% were pain-free, and 60.4% were free from the most bothersome symptom (MBS). In comparison, available data on Lasmiditan2 shows 59% of patients had pain relief at 2-hours, 32.2% were pain free and 40.9% were MBS-free; for Ubrogepant3 pain relief at 2-hours was 58.8%, while 25.5% of patients were pain free; and for Rimegepant4 at 2-hours pain relief was at 61.2%, with 32.9% of patients pain free. At the 24-hour mark, sustained pain freedom with Cefaly® Acute was 25% of patients. In contrast, Ubrogepant showed 21.6%, while Rimegepant demonstrated 28.2%.
Based on these encouraging positive results CEFALY Technology is now moving forward with a Phase 3 clinical trial in the US that is scheduled to be completed by the end of the year.
Usual acute treatment for migraine attacks are triptans but these medications have several important shortcomings: a significant number of migraineurs are unresponsive to triptans; they are contraindicated for patients having cardiovascular problems; they can cause significant side effects; and excessive triptan intake leads to medication overuse headache, a major cause of migraine chronification.
"We've made huge technical advances in recent years that have led to new device generations that are much more efficient than before. Recent improvements led to the Cefaly® Acute and now the new clinical data shows that it offers the best solution for the abortive treatment of migraine," said Dr. Pierre Rigaux, the chief executive officer of CEFALY Technology. "We are very excited by these results and eager to begin Phase 3 to provide full evidence that Cefaly® Acute as the first line abortive migraine therapy offers better efficacy than the triptans, fulfilling patients' unmet needs, and having next-to-no side effects, while remaining the cheapest overall treatment."
About MigraineMigraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation5. An estimated 39 million Americans suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $36 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) expenses each year in the United States.
About CEFALY TechnologyCEFALY Technology is a Belgium-based company, with US offices based in Wilton, Connecticut, specializing in electronics for medical applications. It has developed external cranial stimulation technology for applications in the field of neurology; in particular for treating migraines. For more information, visit http://www.cefaly.us. Find Cefaly on Twitter: @Cefaly and on Facebook: http://www.facebook.com/CefalyEN.
1 Acute Treatment of Migraine With e-TNS (ACME). U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT02590939. September 13, 2017
2 CoLucid Pharmaceuticals press release. CoLucid Pharmaceuticals, Inc. https://globenewswire.com/news-release/2016/09/06/869611/0/en/CoLucid-Pharmaceuticals-Announces-Achievement-of-Both-Primary-and-Key-Secondary-Endpoints-in-the-SAMURAI-Phase-3-Pivotal-Trial-of-Lasmiditan-in-Migraine.html. September 6, 2016.
3 A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. National Center for Biotechnology Information, U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/pubmed/27269043. June 6, 2016.
4 BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. National Center for Biotechnology Information, U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/pubmed/23965396. August 21, 2013.
5 Migraine facts. Migraine Research Foundation website. http://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed January 23, 2018.
Media Contact: Maria Coder[email protected]
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SOURCE CEFALY Technology
