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6 Diseases |  |
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10 Trials |  |
617 News |  |
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- ||| Nurtec (riluzole sublingual) / Portage, Ubrelvy (ubrogepant) / Allergan, rimegepant (BHV-3000) / Portage
#hcne2020stowe @HeadacheCoopNE @alanrapoport Fantastic lecture on new abortives for #migraine treatments Nurtec (Rimegepant) ODT 75 mg 8/month one at onset, Ubrely (Ubrogepant) 50-100 mg 10/month one at onset may repeat in 2hrs, Reywow (lasmitidan) 50-100 mg watch for CNS AEs, (Twitter) - Feb 28, 2020
- || Ubrelvy (ubrogepant) / Allergan
Reimbursement: It works but pharmacies can’t get it. I had some samples got insurance pre approval but no one can get it. #Ubrelvy (Twitter) - Feb 23, 2020
- ||||| Ubrelvy (ubrogepant) / Allergan
Clinical: Ubrogepant, an Acute Treatment for #Migraine, Improved Patient‐Reported Functional Disability and Satisfaction in 2 Single‐Attack Phase 3 RCTs (ACHIEVE I and II) @daviddodick, Richard Lipton, Jessica Ailani, @rashmihalker, Anand Shewale et al https://t.co/i97D0Fg01K (Twitter) - Feb 20, 2020
- || Ubrelvy (ubrogepant) / Allergan
As ubrogepant is now available in pharmacies, it is helpful to remind ourselves of the small therapeutic gain and the need to critically read the primary literature. @eloder https://t.co/c8W5fXrXIW (Twitter) - Feb 3, 2020
- || Ubrelvy (ubrogepant) / AbbVie
Trial completion: Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine (clinicaltrials.gov) - Jan 30, 2020
P1b, N=40, Completed, Sponsor: Allergan
Recruiting --> Completed
- | Ubrelvy (ubrogepant) / Allergan
Journal: Characterization of Ubrogepant: A Potent and Selective Antagonist of the Human Calcitonin Gene‒Related Peptide Receptor. (Pubmed Central) - Jan 30, 2020
SIGNIFICANCE STATEMENT: Ubrogepant is a potent, selective, orally delivered, small-molecule competitive antagonist of the human calcitonin generelated peptide receptor. In vivo studies using a pharmacodynamic model of capsaicin-induced dermal vasodilation (CIDV) in rhesus monkeys and humans demonstrated that ubrogepant produced concentration-dependent inhibition of CIDV, indicating a predictable pharmacokinetic-pharmacodynamic relationship.
- ||| Ubrelvy (ubrogepant) / Allergan
HEOR: The ICER Process: Allergan Engagement Improves Cost Effectiveness Rating For Ubrelvy https://t.co/hUhhM3VtUO #PinkSheet (Twitter) - Jan 26, 2020
- Ubrelvy (ubrogepant) / AbbVie
Efficacy and Safety of Ubrogepant in Participants Taking Concomitant Preventive Medication () - Jan 21, 2020 - Abstract #AAN2020AAN_2949;
In vivo studies using a pharmacodynamic model of capsaicin-induced dermal vasodilation (CIDV) in rhesus monkeys and humans demonstrated that ubrogepant produced concentration-dependent inhibition of CIDV, indicating a predictable pharmacokinetic-pharmacodynamic relationship. Concomitant preventive medication use did not impact the efficacy of ubrogepant for the acute treatment of migraine and was not associated with additional safety concerns.
- Ubrelvy (ubrogepant) / AbbVie
Safety and Efficacy of Ubrogepant in Participants With Moderate to High Cardiovascular Risk () - Jan 21, 2020 - Abstract #AAN2020AAN_2948;
P3
There was no evidence of increased AEs with higher CV risk. Overall, ubrogepant was safe and well tolerated, with no safety concerns identified.
- Ubrelvy (ubrogepant) / AbbVie
Efficacy Is Maintained With Long-term Intermittent Use of Ubrogepant for the Acute Treatment of Migraine () - Jan 21, 2020 - Abstract #AAN2020AAN_2776;
In this extension trial, efficacy comparable to the placebo-controlled, blinded phase 3 trials was achieved and maintained for 1 year. No safety concerns were identified.
- Ubrelvy (ubrogepant) / AbbVie, Reyvow (lasmiditan) / Eli Lilly, rimegepant (BHV-3000) / Portage
Comparative Efficacy and Safety of Rimegepant Versus Ubrogepant and Lasmiditan for Acute Treatment of Migraine: A Network Meta-analysis (NMA) () - Jan 21, 2020 - Abstract #AAN2020AAN_2766;
Higher doses of lasmiditan were found to be associated with increased dizziness. Limitations to the analysis include limited events with which to precisely estimate safety outcomes.
- Ubrelvy (ubrogepant) / AbbVie
Ubrogepant is Effective in the Acute Treatment of Migraine with Mild Pain () - Jan 21, 2020 - Abstract #AAN2020AAN_2597;
P3
Limitations to the analysis include limited events with which to precisely estimate safety outcomes. Treating migraine patients with ubrogepant when headaches are mild rather than moderate/severe increases the likelihood of rendering them free of pain and associated symptoms.
- Ubrelvy (ubrogepant) / AbbVie
An Optional Second Dose of Ubrogepant is Effective in Achieving 2-Hour Pain Freedom in the Acute Treatment of Migraine () - Jan 21, 2020 - Abstract #AAN2020AAN_2091;
P3
Ubrogepant is the first and only treatment to demonstrate statistically higher rates of pain freedom at second dose compared to placebo. No safety concerns were identified following 2 doses of ubrogepant.
- Ubrelvy (ubrogepant) / AbbVie
Ubrogepant Achieves Onset of Pain Relief at 1 Hour for the Acute Treatment of Migraine () - Jan 21, 2020 - Abstract #AAN2020AAN_644;
P3
Although effective concentrations of ubrogepant for CGRP receptor blockade were achieved at ~11 minutes, the earliest group-level clinical effect, pain relief, statistically separated from placebo at 1 hour. Ubrogepant is safe and well-tolerated; no safety concerns identified.
- Ubrelvy (ubrogepant) / AbbVie
Ubrogepant for the Acute Treatment of Migraine: Pooled Safety and Tolerability From ACHIEVE I and ACHIEVE II Phase 3 Studies () - Jan 21, 2020 - Abstract #AAN2020AAN_640;
P3
Ubrogepant is safe and well-tolerated; no safety concerns identified. Overall, ubrogepant 50 mg was well tolerated, with no new safety concerns identified from the larger, pooled ACHIEVE I and II trial data.
- Ubrelvy (ubrogepant) / Allergan
Efficacy of Ubrogepant in a Preclinical Model of Medication Overuse Headache () - Jan 21, 2020 - Abstract #AAN2020AAN_583;
Male or female Sprague-Dawley rats received 6 oral administrations of sumatriptan over 10 days and cephalic and hindpaw allodynia was repeatedly evaluated. This study demonstrates that ubrogepant, a small-molecule CGRP antagonist, shows similar efficacy as sumatriptan in a preclinical model of MOH consistent with the causal relationship of CGRP to migraine pain.
- | Ubrelvy (ubrogepant) / Allergan, Reyvow (lasmiditan) / Eli Lilly, rimegepant (BHV-3000) / Portage
Journal: New horizons for acute and prophylactic treatments of migraine (Pubmed Central) - Jan 16, 2020
These neuropeptides include orexins, oxytocin, neuropeptide Y (NPY) and pituitary adenylate cyclase-activating polypeptide (PACAP). In addition, other promising drugs for the treatment of migraine are nitric oxide synthase inhibitors and acid-sensing ion channel (ASIC) blockers.
- || Ubrelvy (ubrogepant) / Allergan
New Drug Trials Snapshot available for Ubrelvy (ubrogepant): https://t.co/3p1wPbCR3T. (Twitter) - Jan 14, 2020
- ||| Ubrelvy (ubrogepant) / Allergan
The drug will be sold under the name #Ubrelvy https://t.co/4NhzikrrFP via @CNN #Migraine #ChronicPain (Twitter) - Dec 26, 2019
- |||| Ubrelvy (ubrogepant) / Allergan
Clinical, FDA event: @MigraineFounda2 @daviddodick @petergoadsby @MigraineAssist @MigraineBuddy @BrainandLifeMag @ihs_official @WFNRehab @wfneurology On December 23, 2019, the FDA approved ubrogepant (UBRELVY™) for the acute treatment of migraine with or without aura in adults. (Twitter) - Dec 24, 2019
- ||| ubrogepant (MK1602) / Allergan
FDA event: #BreakingNews @US_FDA approves new medication @UBRELVY (ubrogepant) #BoldForLife https://t.co/MrC2zpKD9V (Twitter) - Dec 23, 2019
- | ubrogepant (MK1602) / Allergan
Journal: Ubrogepant for the Treatment of Migraine. (Pubmed Central) - Dec 22, 2019
P3
Further trials are needed to determine the durability and safety of ubrogepant for acute migraine treatment and to compare it with other drugs for migraine. (Funded by Allergan; ClinicalTrials.gov number, NCT02828020.).
- || ubrogepant (MK1602) / Allergan
Original Article: Ubrogepant for the Treatment of Migraine https://t.co/QHPNhx4ovk (Twitter) - Dec 9, 2019
- ||| ubrogepant (MK1602) / Allergan
Nice job @daviddodick @mayoclinic Ubrogepant for the Treatment of Migraine | NEJM https://t.co/YkDwj1agVA (Twitter) - Dec 4, 2019
- || ubrogepant (MK1602) / Allergan
Clinical, Journal: Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. (Pubmed Central) - Nov 29, 2019
P3
Further research is needed to assess the effectiveness of ubrogepant against other acute treatments for migraine and to evaluate the long-term safety of ubrogepant among unselected patient populations. ClinicalTrials.gov Identifier: NCT02867709.
- || Ubrelvy (ubrogepant) / AbbVie
New P1 trial: Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine (clinicaltrials.gov) - Nov 27, 2019
P1b, N=40, Recruiting, Sponsor: Allergan
- || Ubrelvy (ubrogepant) / AbbVie
Clinical, Journal: Population PK Analyses of Ubrogepant (MK-1602), a CGRP Receptor Antagonist: Enriching In-Clinic Plasma PK Sampling With Outpatient Dried Blood Spot Sampling. (Pubmed Central) - Nov 22, 2019
What has been learned from this program has informed the broader integrated strategy of Merck & Co., Inc. (Kenilworth, NJ) for DBS implementation in clinical trials and research to improve the precision of PK data collected in an outpatient setting.
- |||| ubrogepant (MK1602) / Allergan
Clinical: Pain freedom at 2 hours: 21.8% w/ ubrogepant 50-mg 20.7% w/ ubrogepant 25-mg 14.3% w/ placebo group OR 1.62 (50mg vs placebo) the miracle cure that was promised? (Twitter) - Nov 21, 2019
- |||| ubrogepant (MK1602) / Allergan
🆕 @JAMANeuro The ACHIEVE II RCT. #Ubrogepant 50 mg effective for pain &symptoms relief in acute #migraine #Ubrogepant is an “oral” #CGRP receptor antagonist #HeadacheTipOfTheDay @KohanLynn @MagdaAnitescuMD @DmitriSouza @Rick_Pescatore @aihsHeadache https://t.co/MUIguIFx21 (Twitter) - Nov 19, 2019
- | Review, Journal: History and Review of anti-Calcitonin Gene-Related Peptide (CGRP) Therapies: From Translational Research to Treatment. (Pubmed Central) - Nov 11, 2019
Two gepants, ubrogepant and rimegepant, have completed positive pivotal trials for acute treatment of migraine, but have not yet been submitted to the FDA for this indication. Conclusions - The development of anti-CGRP therapies opens a new era in the acute and preventive treatment of primary headache disorders.
- | Review, Journal: Anti-Calcitonin Gene-Related Peptide (CGRP) Therapies: Update on a Previous Review After the American Headache Society 60th Scientific Meeting, San Francisco, June 2018. (Pubmed Central) - Nov 11, 2019
Conclusions - The development of anti-CGRP therapies opens a new era in the acute and preventive treatment of primary headache disorders. The development of anti-CGRP therapies opens a new era in the acute and preventive treatment of primary headache disorders.
- | Journal: Emerging drugs for migraine treatment: an update. (Pubmed Central) - Oct 16, 2019
Several more studies are needed to fully understand the clinical potential, long-term safety and cost-effectiveness of these therapies. This paramount achievement should stimulate the development of further research in the migraine field.
- | Review, Journal: CGRP as the target of new migraine therapies - successful translation from bench to clinic. (Pubmed Central) - Aug 30, 2019
We describe the biology of CGRP signalling, summarize key clinical evidence for the role of CGRP in migraine headache, including the efficacy of CGRP-targeted treatment, and synthesize what is known about the role of CGRP in the trigeminovascular system. Finally, we consider how the latest findings provide new insight into the central role of the trigeminal ganglion in the pathophysiology of migraine.
- | Journal: Primary headache disorders: Five new things. (Pubmed Central) - Jul 26, 2019
For patients seeking a nondrug therapy, neuromodulation approaches, single-pulse transcranial magnetic stimulation, noninvasive vagus nerve stimulation (nVNS), and external trigeminal nerve stimulation, represent licensed, well-tolerated approaches to migraine treatment...Headache medicine has made remarkable strides, particularly in understanding migraine and cluster headache in the past 5 years. For the most common reason to visit a neurologist, therapeutic advances offer patients reduced disability and neurologists a rewarding, key role in improving the lives of those with migraine and cluster headache.
- | ubrogepant (MK1602) / Allergan, lasmiditan (COL-144) / Eli Lilly, rimegepant (BHV-3000) / Portage
Review, Journal: Therapeutic novelties in migraine: new drugs, new hope? (Pubmed Central) - Jul 19, 2019
For the most common reason to visit a neurologist, therapeutic advances offer patients reduced disability and neurologists a rewarding, key role in improving the lives of those with migraine and cluster headache. Collectively, novel migraine therapies represent a major progress in migraine treatment and will undoubtedly transform headache medicine.
- | Journal: Gepants for the treatment of migraine. (Pubmed Central) - Jun 30, 2019
Expert opinion: Available data suggest that second generation of gepants has clinical efficacy similar to triptans and lasmiditan (5-HT1F receptor agonist) and has improved tolerability. Future studies will assess their safety, especially in specific populations such as patients with cardiovascular disease and pregnant women.
- || ubrogepant (MK1602) / Allergan
Goede resultaten ubrogepant bij acute migraine in ACHIEVE I/II https://t.co/F26JPU8pbB #AAN2019 (Twitter) - May 10, 2019
- ||| ubrogepant (MK1602) / Allergan
P3 data: Ubrogepant phase 3 ACHIEVE II results discussed now at #AANAM (Twitter) - May 8, 2019
- ||| Translarna (ataluren) / PTC Therapeutics, Sanofi, ubrogepant (MK1602) / Allergan, Emflaza (deflazacort) / Marathon, PTC Therapeutics
Clinical: FYI 2019 #AAN19 conference (May 4-10) in Philadephia. Kicks off - Sunday, May 5: Posters for $NVS/$AVXS SMA GT program (IT delivery, STR1VE, and presymptomatic patients); $AGN ubrogepant liver safety; and $PTCT's Translarna and Emflaza (Twitter) - May 4, 2019
- ||||||| Ubrelvy (ubrogepant) / AbbVie
Trial completion: An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine (clinicaltrials.gov) - Aug 15, 2018
P3, N=1254, Completed, Sponsor: Allergan
Future studies will assess their safety, especially in specific populations such as patients with cardiovascular disease and pregnant women. Active, not recruiting --> Completed
- ||||||| Ubrelvy (ubrogepant) / AbbVie
Trial completion, Trial completion date, Trial primary completion date: ACHIEVE II: Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (clinicaltrials.gov) - Mar 1, 2018
P3, N=1686, Completed, Sponsor: Allergan
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Mar 2018 --> Feb 2018 | Trial primary completion date: Mar 2018 --> Feb 2018
- ||||||| Ubrelvy (ubrogepant) / AbbVie
Trial completion: ACHIEVE I: Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine (clinicaltrials.gov) - Jan 11, 2018
P3, N=1672, Completed, Sponsor: Allergan
Active, not recruiting --> Completed | Trial completion date: Mar 2018 --> Feb 2018 | Trial primary completion date: Mar 2018 --> Feb 2018 Active, not recruiting --> Completed
- |||| Ubrelvy (ubrogepant) / AbbVie
Trial primary completion date: ACHIEVE II: Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (clinicaltrials.gov) - Jan 9, 2018
P3, N=1686, Active, not recruiting, Sponsor: Allergan
Active, not recruiting --> Completed Trial primary completion date: Dec 2017 --> Mar 2018
- ||||| Ubrelvy (ubrogepant) / AbbVie
Enrollment closed: ACHIEVE II: Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (clinicaltrials.gov) - Dec 12, 2017
P3, N=1650, Active, not recruiting, Sponsor: Allergan
Trial primary completion date: Dec 2017 --> Mar 2018 Recruiting --> Active, not recruiting
- ||||| Ubrelvy (ubrogepant) / AbbVie
Enrollment closed: ACHIEVE I: Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine (clinicaltrials.gov) - Nov 27, 2017
P3, N=1672, Active, not recruiting, Sponsor: Allergan
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||||| Ubrelvy (ubrogepant) / AbbVie
Enrollment closed: An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine (clinicaltrials.gov) - Jul 13, 2017
P3, N=1200, Active, not recruiting, Sponsor: Allergan
Recruiting --> Active, not recruiting Enrolling by invitation --> Active, not recruiting
- ||||| Ubrelvy (ubrogepant) / AbbVie
Enrollment change: ACHIEVE II: Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (clinicaltrials.gov) - Jun 22, 2017
P3, N=1650, Recruiting, Sponsor: Allergan
Enrolling by invitation --> Active, not recruiting N=1350 --> 1650
- ||||| Ubrelvy (ubrogepant) / AbbVie
Enrollment change: ACHIEVE I: Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine (clinicaltrials.gov) - Jun 22, 2017
P3, N=1650, Recruiting, Sponsor: Allergan
N=1350 --> 1650 N=1350 --> 1650
- |||||| Ubrelvy (ubrogepant) / AbbVie
Enrollment open: An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine (clinicaltrials.gov) - Oct 6, 2016
P3, N=1200, Enrolling by invitation, Sponsor: Allergan
N=1350 --> 1650 Not yet recruiting --> Enrolling by invitation
- |||||| Ubrelvy (ubrogepant) / AbbVie
Enrollment open: ACHIEVE II: Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (clinicaltrials.gov) - Sep 14, 2016
P3, N=1350, Recruiting, Sponsor: Allergan
Not yet recruiting --> Enrolling by invitation Not yet recruiting --> Recruiting