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Unexpected lack of effect of COVID-19 lockdown on migraine in patients taking anti-CGRP therapies

Patients taking anti-CGRP therapies did not experience more migraines or reduced quality of life during COVID-19 lockdown in Italy, according to results of an observational study of 147 participants, 105 with chronic migraine (CM) and 42 with episodic migraine (EM). During the first month of lockdown (T-lock) monthly migraine days (MMDs) were reduced from 10.5 …

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Galcanezumab quality of life benefits similar in Japanese and Caucasian patients

Improvements in health related quality of life (QoL) in Japanese patients with episodic migraine treated with galcanezumab are comparable to those seen in global studies of mainly Caucasian patients. Results of a prespecified analysis of data from a Phase 2, randomised, double-blind, placebo-controlled study in 40 Japanese centres showed significantly greater improvements in Migraine-Specific Quality-of-Life …

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Reversion from chronic to episodic migraine persists during long term erenumab treatment

Over nine out of 10 patients who revert from chronic to episodic migraine (EM) after 12 weeks of erenumab are likely to maintain their episodic status after a further 12 months of treatment, according to post-hoc data from an early Phase 2 trial.1,2 Among 181 patients who completed 64 weeks of erenumab, 98 (54.1% [95% …

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Potential advantages of targeting both CGRP and PACAP in chronic migraine and post-traumatic headache

Inhibiting both CGRP and PACAP signalling in trigeminal ganglion (TG) neurons may be more effective in treating chronic migraine (CM) and post-traumatic headache (PTH) than targeting individual signalling pathways. This is the conclusion of researchers whose preclinical research has demonstrated that recurring migraine episodes alter the strength of CGRP and PACAP signalling in TG neurons. …

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Nurtec (rimegepant) Phase 2/3 data in migraine prevention published

Results of a Phase 2/3 study (NCT03732638) showing that oral rimegepant 75 mg every other day is effective for migraine prevention are published today in The Lancet.1 Top-line data from the study were reported earlier this year.2 An efficacy analysis of data from 695 participants (rimegepant=347, placebo=348) showed that rimegepant was superior to placebo for …

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NICE recommends Aimovig (erenumab) use on NHS after appeal

The National Institute for Health and Care Excellence (NICE) has recommended erenumab as an option for migraine prevention free of charge on the National Health Service (NHS) in England and Wales.1 This overturns a previous decision against erenumab’s availability on the NHS,2 and it is expected that the new decision will be confirmed by the …

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Dual blockade of meningeal nociceptors demonstrated with atogepant/ onabotulinumtoxinA combination

Combining atogepant and onabotulinumtoxinA has been shown to inhibit high-threshold (HT) and wide-dynamic-range (WDR) neurons through dual blockade of the Aδ and C classes of meningeal nociceptors. In a preclinical study, single-unit recordings were obtained of HT and WDR neurons in the spinal trigeminal nucleus, and cortical spreading depression was then induced following pretreatment with …

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NICE confirms Emgality (galcanezumab) availability on NHS

The National Institute for Health and Care Excellence (NICE) has confirmed that Emgality (galcanezumab) can be prescribed for migraine prevention free of charge on the National Health Service (NHS) in England and Wales. The drug can be prescribed to patients with episodic or chronic migraine who have four or more migraine days a month and …

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Erenumab demonstrates central effects in patients with migraine

Erenumab appears to have central as well as peripheral effects, according to new data from a functional imaging study in patients with migraine before and after erenumab treatment. In the fMRI study on 27 patients with migraine, erenumab 70 mg resulted in a decrease in activation in the right thalamus (contralateral to the stimulated side), …

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Erenumab superior to topiramate in migraine prevention

Top line results from the Phase 4 HER-MES study of erenumab versus topiramate have demonstrated the superiority of erenumab in migraine prevention. Erenumab had a superior tolerability and efficacy profile compared to topiramate, with fewer discontinuations during the double-blind, 24-week treatment phase. Erenumab also showed superior efficacy, with a greater proportion of patients achieving a 50% reduction in their …

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Increase in plasma CGRP levels after longer term erenumab treatment

Circulating CGRP levels have been shown to increase by about 40% in patients taking erenumab for at least six months. New data, published in the The Journal of Headache and Pain, support the possibility that long term blockade of CGRP receptors may induce an increase in systemic CGRP levels via a classical upregulation mechanism. However, …

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NICE makes broad migraine recommendation for Emgality (galcanezumab) on NHS

The National Institute for Health and Care Excellence (NICE) has recommended that Emgality (galcanezumab) can be prescribed free to patients with episodic or chronic migraine in England and Wales. The final appraisal document recommends that galcanezumab can be used for preventing migraine in adults who have four or more migraine days a month and have …

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Long-term fremanezumab data show sustained efficacy and tolerability

Quarterly and monthly fremanezumab are well tolerated and demonstrate sustained improvements in monthly migraine days, headache days, and headache-related disability for up to 12 months. These are the findings from a randomised, double-blind, parallel-group study which compared the effects of dosing schedules in 1890 adults with chronic migraine (CM) or episodic migraine (EM), most of …

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Chronic cluster headache data support off-label use of anti-CGRP therapy

Real world data from German centres support off-label use of anti-CGRP therapy in chronic cluster headache (CCH),1 despite previous disappointing clinical trial results.2 In 22 patients with CCH who had tried a mean 6.5+2.4 preventive medicines, the average number of weekly attacks was 23.3+16.4 at baseline and significantly decreased by -9.2+9.7 in the first month …

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Vypeti (eptinezumab) shows efficacy during migraine attacks

  Starting Vyepti (eptinezumab) during a migraine attack significantly reduces time to freedom from headache pain and absence of most bothersome symptom compared to placebo, according to top-line results from the RELIEF study. Significant improvements were also seen in secondary endpoints, including pain freedom and absence of most bothersome symptom at 2 hours after the …

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HALO data support quality of life and productivity benefits of fremanezumab

Fremanezumab significantly improved migraine-specific quality of life, overall health status, patients’ global impression of change with treatment, and productivity in patients with chronic migraine. This was the conclusion from the latest analysis of data from the placebo controlled HALO CM study which investigated the efficacy and safety of quarterly and monthly fremanezumab. In the study …

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STRIVE shows efficacy of erenumab in women with menstrual migraine

Women with a history of menstrual migraine respond as well to erenumab as other patients with migraine, according to results of a post hoc, subgroup analysis of the phase 3 STRIVE study in episodic migraine. Of 814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were ≤ 50 years old. …

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Erenumab shows promise in highly refractory migraine

Promising real-life data have been reported with erenumab in patients with highly refractory migraine. Those with episodic migraine (EM) had tried at least five approved preventive medications and those with chronic migraine (CM) had tried at least six. Reasons for stopping previous therapies were lack of efficacy, adverse effects, or contraindications. Data collected on 100 …

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Phase 3 ADVANCE data support atogepant in migraine prevention

Once-daily, oral atogepant significantly reduced mean monthly migraine days (MMDs) at 12 weeks, according to top-line data from the Phase 3 ADVANCE trial in episodic migraine. Results show that mean MMDs were reduced from baseline by 3.69, 3.86 and 4.2 days with atogepant 10 mg, 30 mg or 60 mg respectively, compared to 2.48 days …

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Erenumab reduces intensity and frequency of cluster headache

Erenumab has been shown to reduce cluster headache (CH) frequency and intensity in a small case series of five patients with both migraine without aura and CH. All patients had failed on previous preventive treatments and showed good results for both migraine and CH following treatment with erenumab 70 or 140 mg. CH improvements occurred …

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Erenumab shows promise in post-traumatic headache

Patients with post-traumatic headache (PTH) responded well to erenumab 140 mg in a single-arm, open label study, reported in The Journal of Headache and Pain. Eighty nine of 100 patients treated a mean 59 months after their brain injury completed the 12-week study of erenumab 140 mg monthly. Mean monthly headache days of moderate to …

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NICE publishes Ajovy (fremanezumab) guidance for NHS use

Doctors in England and Wales can now prescribe Ajovy (fremanezumab) for the preventive treatment of migraine in adults, free of charge on the NHS. This follows publication of guidance by the National Institute for Health and Care Excellence (NICE).1 NICE has recommended fremanezumab for patients with chronic migraine (>15 headache days per month for more …

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Ajovy (fremanezumab) approved for migraine prevention in Canada

Ajovy (fremanezumab) has been approved by Health Canada for the preventive treatment of migraine in adults who have at least four migraine days per month. The indication is in line with that for Aimovig (erenumab) and Emgality (galcanezumab) which are currently approved for prescription in Canada. The Ajovy approval was supported by data from two …

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Phase 2 vazegepant study proposed in COVID-19

Vazegepant, the intranasal, small molecule CGRP receptor antagonist, is expected to enter a Phase 2 study to investigate its effects in mitigating the excessive immune response seen in patients with pulmonary complications of COVID-19 disease. The proposed study which is to be carried out by vazegepant developer, Biohaven, in collaboration with Thomas Jefferson University, Philadelphia, …

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US migraine experts urge easier access to anti-CGRP therapies during COVID-19 crisis

Leading US migraine specialists have called on insurance providers to eliminate prior authorisation and step therapy requirements for migraine treatment during the COVID-19 crisis and enable easier access to anti-CGRP therapies for appropriate patients. In an editorial accepted for publication in Headache, Dr Christina Szperka and colleagues suggest that, at such a difficult time, patients …

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Nurtec (rimegepant) shows benefits in migraine prevention

Oral rimegepant 75 mg every other day significantly reduces monthly migraine days compared to placebo in patients with episodic or chronic migraine, according to results of a pivotal Phase 3 trial reported by Biohaven. The company now plans to submit rimegepant for regulatory approval for preventive treatment of migraine with the aim of it becoming …

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New research underlines CGRP role in trigeminal neuralgia

With early studies of anti-CGRP therapy underway in trigeminal neuralgia (TN), newly published research supports a role for CGRP in the pathophysiology of the disease and for CGRP inhibition in the analgesic mechanism of botulinumtoxinA (BTX-A) in TN. In a pilot study completed by 45/47 patients with classical TN and 30/47 matched healthy controls, plasma CGRP levels …

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Galcanezumab as an option after botulinum toxin failure

A post hoc analysis of galcanezumab data from the EVOLVE-1, EVOLVE-2 and REGAIN trials suggests that the CGRP antibody may be a useful next step for patients with migraine who fail to respond to onabotulinumtoxinA preventive therapy. Pooled data from 2886 patients with episodic or chronic migraine included 129 patients who failed onabotulinumtoxinA, with most …

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Could GLP-1 agonists help patients with anti-CGRP therapy related constipation?

Measurement of glucagon-like peptide-1 (GLP-1) and GLP-1 metabolite levels in patients taking anti-CGRP therapies could provide useful insights into whether GLP-1 supplementation may benefit those with treatment-associated constipation. This suggestion comes in a letter from leading Danish migraine researchers published in the Journal of Headache and Pain.1 Previous research has demonstrated CGRP-induced GLP-1 secretion and …

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Vazegepant moves towards Phase 3 trial in acute migraine

The intranasal CGRP antagonist, vazegepant, is expected to enter a Phase 3 clinical trial for the acute treatment of migraine after non clinical and Phase 2 issues were successfully addressed with the US Food and Drug Administration (FDA). Biohaven, which is developing the drug, expects to advance the 10 mg dose of intranasal vazegepant into …

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NICE recommends Ajovy (fremanezumab) use on NHS in England

The National Institute for Health and Care Excellence (NICE) has recommended approval for Ajovy (fremanezumab) for the preventive treatment of migraine in adults on the NHS in England.1 This means that up to 10,000 people may benefit from treatment. The draft guidance recommends that fremanezumab can be used for preventing chronic migraine in people who …

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Emgality (galcanezumab) refused EU approval for episodic cluster headache

The European Medicines Agency (EMA) has refused a licence extension for Emgality (galcanezumab) for the prevention of episodic cluster headache.1 The Committee for Medicinal Products for Human Use (CHMP), which advises the EMA, said that the single study used to support the application “did not show clearly that Emgality is effective for preventing attacks” in …

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Nurtec ODT (rimegepant) receives US approval for acute migraine treatment

Nurtec ODT (rimegepant) has been approved by the US Food and Drug Administration for the acute treatment of migraine with or without aura in adults. Nurtec ODT is formulated as a rapidly disintegrating tablet and the recommended dose is 75 mg taken orally. This is also the maximum recommended dose during a 24-hour period. The …

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US report supports likely cost effectiveness of ubrogepant and rimegepant

The Institute for Clinical and Economic Review (ICER) has concluded that, in patients with moderate-to-severe migraine for whom triptans are not effective, not tolerated or contraindicated, ubrogepant and rimegepant do not exceed commonly accepted thresholds for cost effectiveness in the USA. In a new report, ICER – a US independent non-profit research organisation that reports …

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Vyepti (eptinezumab) approved for migraine prevention in USA

Vyepti (eptinezumab) has been approved by the US Food and Drug Administration (FDA) for the preventive treatment of migraine in adults and will be available in April 2020. The recommended dose is 100 mg iv every three months, though some patients may benefit from a dose of 300 mg iv. The approval was supported by …

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Galcanezumab data published for chronic cluster headache

The failure of galcanezumab to significantly improve outcomes for patients with chronic cluster headache (cCH) suggests a distinct biology for the disease and underlines the significant unmet need for safe, effective, and well-tolerated preventive treatment. These are the conclusions of investigators reporting results of the Phase 3, 12-week, double-blind, placebo-controlled trial of galcanezumab in cCH.1 …

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NICE to re-examine decision to reject Aimovig (erenumab) use on NHS in England

The National Institute for Health and Care Excellence (NICE) is to consider data related to the cost effectiveness of Aimovig (erenumab) in patients with chronic migraine who have failed treatment with botulinum toxin or when the toxin is contraindicated.1 This follows an appeal against NICE guidance issued last year to reject all use of erenumab …

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US patients to get autoinjector for Ajovy (fremanezumab)

US patients will soon be able to administer Ajovy (fremanezumab) through an autoinjector instead of a syringe. This follows US Food and Drug Administration (FDA) approval for the device to be used with fremanezumab for migraine prophylaxis. “Ajovy is the only FDA-approved anti-CGRP that offers the flexibility of quarterly (675 mg) or monthly (225 mg) …

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Positive top-line fremanezumab results for migraine prevention in Japanese studies

Preliminary results from two Phase 2/3 trials of fremanezumab in Japan have indicated that primary endpoints were achieved with statistical significance versus placebo in patients which chronic migraine and episodic migraine. Improvements versus placebo were also shown for secondary endpoints. No clinically significant adverse events were observed in patients who received fremanezumab. Fremanezumab is being …

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Ajovy (fremanezumab) prescription agreed for migraine prophylaxis in Scotland

Ajovy (fremanezumab) can be prescribed on the National Health Service (NHS) in Scotland for patients with chronic or episodic migraine who have failed on three or more preventive treatments, following a decision from the Scottish Medicines Commission (SMC).1 The ruling is based on the results of three phase 3 studies showing superiority of fremanezumab over …

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Vazegepant shows efficacy in acute migraine treatment

Intranasal vazegepant 10 and 20 mg doses were statistically superior to placebo in achieving freedom from pain and the most bothersome symptom two hours after administration, according to results of a dose ranging Phase 2/3 study in 1673 patients with acute migraine. Pain freedom at two hours was 15.5% with placebo compared to 19.6% with …

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CGRP switching may improve response

Switching non-responders to a CGRP monoclonal antibody (mAb) to a different anti-CGRP agent may elicit a better response, say researchers from Germany in a letter published in Headache. They report on three patients, two with chronic and one with episodic migraine, who benefitted from the change of treatment. No response had been seen to erenumab …

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Ubrelvy (ubrogepant) receives US approval for acute migraine treatment

Ubrelvy (ubrogepant) has become the first oral CGRP receptor antagonist (gepant) to be approved for the acute treatment of migraine. The US Food and Drug Administration (FDA) has licensed ubrogepant for the acute treatment of migraine with or without aura in adults. “The FDA’s approval of Ubrelvy, a new oral option that is effective in the acute …

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Fresh insights on site of action for CGRP therapy

CGRP monoclonal antibodies (mAbs)and gepants may exert their effects at sites of axon to axon interaction between C-fibres and Aδ fibres in the trigeminal ganglion (TG) and the dura mater, according to newly published research. The trigeminal system has long been suggested as a possible site of action for CGRP MAbs but the precise location …

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Study casts new light on migraine signalling pathway

A new study of migraine induction has shown that two different intracellular signalling pathways trigger similar attacks within the same patients, suggesting that the pathways converge and there is a common driver of attacks. In a group of 34 patients, migraine was induced using CGRP on one day and sildenafil on another. CGRP is known …

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Neuropeptide study suggests missing link between migraine and opioid overuse pain

Analysis of more than 1500 neuropeptides in brain tissue from animal models of migraine and opioid-induced hyperalgesia (OIH) has identified 16 peptides whose levels were altered between the two conditions. As might be expected, CGRP was among seven peptides associated with chronic migraine, but it was not amongst the pain-processing peptides affected in OIH. Pituitary …

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Three-year erenumab data support safety and tolerability

Interim data from a five-year open label extension study of erenumab in episodic migraine have demonstrated a similar safety and tolerability profile at three-plus years to that seen in short-term placebo-controlled trials (NCT01952574). Recently published longest-term results for an anti-CGRP therapy show an exposure-adjusted adverse event (AE) patient incidence rate for erenumab of 132/100 patient-years, …

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Novartis withdraws Aimovig reimbursement submission in Australia

Novartis has decided not to pursue a third attempt to gain reimbursement for Aimovig (erenumab) in Australia under the Pharmaceutical Benefits Scheme (PBS). The company has withdrawn its application to the Pharmaceutical Benefits Advisory Committee (PBAC) which recommends new medicines for listing on the PBS. The PBS lists all medicines in Australia that can be …

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NICE rejects Aimovig (erenumab) use on NHS in England

The National Institute for Health and Care Excellence (NICE) has ruled that Aimovig (erenumab) should not be available on the National Health Service (NHS) in England.1 Despite new cost effectiveness analyses submitted by erenumab manufacturer, Novartis, after draft guidance rejected the drug in January2,3, NICE has confirmed its previous decision. NICE said that although evidence …

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Eptinezumab is focus of planned Lundbeck takeover of Alder BioPharmaceuticals

Eptinezumab, the quarterly i.v anti-CGRP therapy developed by Alder Biopharmaceuticals, is the focus of a planned takeover of the company by Lundbeck for nearly $2 billion. Lundbeck plans to develop and launch eptinezumab worldwide, following the first expected approval of the drug for migraine prevention in the USA in early 2020. Subsequent regulatory submissions are …

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