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FDA Approves Theranica's Nerivio® for Acute Treatment of Migraine in Adolescents

Retrieved on: 
Monday, January 25, 2021

The use of the device in the treatment of adolescents is supported by a study recently published in Headache .

Key Points: 
  • The use of the device in the treatment of adolescents is supported by a study recently published in Headache .
  • 10% of all school age children and up to 28% of teens between the ages of 15-19 live with migraine.
  • As a result, Nerivio is now widely available as a drug-free alternative to treat migraine.
  • The company's award-winning flagship product, Nerivio, is the first FDA-cleared smartphone-controlled prescription wearable device for acute migraine treatment of episodic or chronic migraine in people 12 years and older.Theranica is expanding its proprietary technology to offer additional solutions for other pain conditions.The Nerivio has received FDA authorization and the CE mark for use in acute treatment of migraine.

Lilly's OVERCOME Study Reveals Nearly 80% of People Reported Improvement in Their Migraine Since Starting a CGRP Monoclonal Antibody for Preventive Treatment

Retrieved on: 
Friday, October 9, 2020

Close to two-thirds (62.6%) said they also used an additional recommended migraine preventive medication with their CGRP mAbs.

Key Points: 
  • Close to two-thirds (62.6%) said they also used an additional recommended migraine preventive medication with their CGRP mAbs.
  • "It is also notable that the OVERCOME survey reported the clinically meaningful distinction between individuals who reported no change in their migraine with those who said their migraine worsened.
  • This distinction can enhance conversations between the healthcare provider and the patient regarding treatment expectations when considering the use of these novel migraine preventive medications."
  • Among respondents who used a CGRP mAb in the previous 3 months, 62.6% used an additional recommended migraine preventive medication.

electroCore Announces 510(k) Clearance of gammaCore™ Label Expansion into Migraine Prevention

Retrieved on: 
Monday, March 30, 2020

The American Migraine Foundation estimates that there are nearly 36 million adults in the United States suffering from migraine.

Key Points: 
  • The American Migraine Foundation estimates that there are nearly 36 million adults in the United States suffering from migraine.
  • gammaCore has been available for the acute treatment of migraine, and now can be used for prevention to more effectively treat these patients.
  • This milestone is clearly a very meaningful expansion of our label indication within our total addressable market.
  • In addition to migraine prevention, gammaCore is currently indicated for adjunctive use for the preventive treatment of cluster headache and for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.

electroCore, Inc. Announces Rebate Agreement with Ascent Health Services for gammaCore Preferred Brand Coverage on all Express Scripts Standard National Formularies

Retrieved on: 
Monday, January 27, 2020

Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients as needed, without the potential side effects associated with commonly prescribed drugs.

Key Points: 
  • Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients as needed, without the potential side effects associated with commonly prescribed drugs.
  • gammaCore is available by prescription only and patients should speak with their doctor about whether gammaCore is right for them.
  • Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
  • The companys initial targets are the preventative treatment of cluster headache and acute treatment of migraine and episodic cluster headache.

Survey Finds Positive HCP Relationships, Negative Quality of Life for Chronic Migraine Patients Who Currently Vs. Never Used CGRP

Retrieved on: 
Monday, January 6, 2020

Additionally, the first abortive CGRP for the acute treatment of migraine was approved in December 2019, after Migraine In America 2019 fielded.

Key Points: 
  • Additionally, the first abortive CGRP for the acute treatment of migraine was approved in December 2019, after Migraine In America 2019 fielded.
  • More than a third of chronic migraine respondents said they currently use a preventive CGRP, while more than half have never used one; additionally, 13% had previously used a preventive CGRP.
  • Chronic migraine respondents currently using a CGRP were more likely to rate their relationships with HCPs positively for most factors.
  • Possibly linked to the volume of symptoms experienced, chronic migraine respondents who currently use a CGRP also had negative views of their quality of life.

Lilly's REYVOW™ (lasmiditan), The First and Only Medicine in a New Class of Acute Treatment for Migraine, Receives FDA Approval

Retrieved on: 
Friday, October 11, 2019

REYVOW has a unique mechanism of action and is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists).

Key Points: 
  • REYVOW has a unique mechanism of action and is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists).
  • As with other medicines with central nervous system (CNS) activity, the FDA required abuse potential studies for REYVOW.
  • The REYVOW Phase 3 development program, including the open-label GLADIATOR study, involved more than 4,000 patients and the treatment of more than 20,000 migraine attacks.
  • "The approval of REYVOW is an exciting development for patients and physicians seeking the potential for pain freedom when a migraine attack happens."

Lilly Announces Positive Results for Emgality™ (galcanezumab) from the CONQUER Study in Patients who Failed Previous Migraine Preventive Treatments

Retrieved on: 
Thursday, August 8, 2019

Results of CONQUER will help us identify the patients that can benefit most from treatment with these."

Key Points: 
  • Results of CONQUER will help us identify the patients that can benefit most from treatment with these."
  • "Preventive treatment failureamong patients with migraine has beena common occurrence," saidDoron Sagman,M.D.,Senior Medical Director, Eli Lilly Canada Inc. (Lilly Canada).
  • "We are pleased that the CONQUER study demonstrated a significant benefit for patients with chronic and episodic migraine who face such high unmet need."
  • InEurope Emgality was approvedinNovember 2018for the prophylaxis of migraine in adults who have at least four migraine days per month.

Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine

Retrieved on: 
Monday, March 11, 2019

DUBLIN, March 11, 2019 /PRNewswire/ --Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults.

Key Points: 
  • DUBLIN, March 11, 2019 /PRNewswire/ --Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults.
  • "As a leader in Chronic Migraine research for more than 20 years, Allergan looks to provide options for patients who need new acute and preventative treatments for migraine.
  • Intermittent use of ubrogepant 50 mg or 100 mg for the acute treatment of migraine attacks over one year was well-tolerated.
  • Ubrogepant is a novel, highly potent, orally-administered CGRP receptor antagonist in development for the acute treatment of migraine.