- |||||||||| Ubrelvy (ubrogepant) / AbbVie
Trial completion date, Trial primary completion date: UNION: Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies (clinicaltrials.gov) - Feb 15, 2024 P4, N=164, Recruiting, Future studies are warranted to further validate these findings and explore long-term outcomes. Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> May 2024
- |||||||||| Ubrelvy (ubrogepant) / AbbVie
Journal: Ubrogepant: Mechanism of action, clinical and translational science. (Pubmed Central) - Jan 28, 2024 Here, we provide an abridged review of ubrogepant, an oral CGRP receptor antagonist, approved for the acute treatment of migraine. We briefly summarize the role of CGRP in migraine pathophysiology, describing the mechanism of action of ubrogepant in the context of this pathway, the clinical pharmacology properties and the clinical development and outcomes, including safety, efficacy, pharmacokinetics, and pharmacodynamics, that supported ubrogepant's approval.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie, Reyvow (lasmiditan) / Eli Lilly, Daiichi Sankyo, Organon, Nurtec ODT (rimegepant ODT) / Pfizer
Journal, HEOR: Treatment Patterns, Healthcare Resource Utilization, and Direct Costs Among Patients Initiating Concomitant Use of a Calcitonin Gene-Related Peptide Monoclonal Antibody (CGRP mAb) and Novel Acute Medication in the United States. (Pubmed Central) - Dec 25, 2023 Concomitant treatment with CGRP mAb and novel acute migraine medications led to reductions in some outcomes of HCRU and direct costs, however, increases were also observed. Treatment utilization, reductions in HCRU and cost savings identified in this study in favor of concomitant CGRP mAb and novel acute medications may help clinicians and other healthcare decision makers assessing appropriate therapeutic options for migraine management.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie
Review, Journal: A Comprehensive Review of the Mechanism, Efficacy, Safety, and Tolerability of Ubrogepant in the Treatment of Migraine. (Pubmed Central) - Dec 4, 2023 However, specific contraindications, such as hypersensitivity, severe hepatic impairment, concurrent use of CYP3A4 inhibitors, pregnancy or breastfeeding, and uncontrolled hypertension, require caution or avoidance of ubrogepant. Despite these limitations, ubrogepant signals a promising new direction in migraine therapeutics.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie, Zavzpret (zavegepant nasal spray) / Pfizer, Nurtec ODT (rimegepant ODT) / Pfizer
Journal: Gepants in the acute management of migraine. (Pubmed Central) - Nov 22, 2023 Despite these limitations, ubrogepant signals a promising new direction in migraine therapeutics. No abstract available
- |||||||||| Ubrelvy (ubrogepant) / AbbVie, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: A Bibliometric and Scientific Knowledge Map Study of Migraine Treatment from 2013 to 2022. (Pubmed Central) - Sep 21, 2023 The current research mainly focuses on CGRP-related therapeutics, such as fremanezumab, erenumab and ubrogepant. Based on the analysis of bibliometric data on migraine treatment over the past decade, the trends and the knowledge graph of the country, organization, author, reference, and the keyword were identified, providing accurate and quick positioning of the critical information in the domain.
- |||||||||| Journal: Blocking the CGRP Receptor: Differences across Human Vascular Beds. (Pubmed Central) - Aug 26, 2023
Interestingly, olcegepant, atogepant and rimegepant, with a Schild plot slope 1 log unit more potent in HMMAs than in HCAs, while telcagepant, ubrogepant and zavegepant, with a Schild plot slope not different from unity, showed similar (<1 log difference) potency across both tissues. As a Schild plot slope < 1 may point to the involvement of multiple receptors, it is important to further identify the receptors involved in the relaxation to CGRP in HCAs, which may be used to improve the cardiovascular safety of future antimigraine drugs.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie
Journal, Adverse events: Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. (Pubmed Central) - Aug 23, 2023 Our results showed that Ubrogepant-induced AEs targeted 4 system organ classes (SOCs), detected 32 Preferred terms (PTs) signals in 9 SOCs, including common Ubrogepant label consistent with Migraine, Nausea, Somnolence, Paraesthesia oral and Dizziness, It also includes the AEs of Hemiparesis, Mental impairment, Dysstasia, Tinnitus, Chest pain, Cold sweat, Neck pain, etc. that have not been demonstrated in previous studies. Our study identified new AEs that have not been reported, which provides a new guidance to deepen the comprehension of the safety of Ubrogepant.
- |||||||||| Review, Journal: A Brief Review of Gepants. (Pubmed Central) - Aug 2, 2023
Additional research is needed to explore occurrence of Raynaud's phenomenon in participants treated with gepants, as it has been associated with CGRP monoclonal antibodies, but are not extensively studied in gepants. Gepants are expected to play a significant role in the next generation of migraine treatments.
- |||||||||| Journal: Drugs for migraine. (Pubmed Central) - Jun 6, 2023
Further studies are needed to confirm these findings. No abstract available
- |||||||||| Journal: The pharmacotherapeutic management of episodic and chronic migraine with gepants. (Pubmed Central) - May 22, 2023
The PubMed literature search included randomized controlled trials, meta-analyses, real-world data, and review articles published in English until January 2023. Whether gepants will be real game changers in the acute treatment of migraine compared to triptans and ditans, or in the prophylactic therapy compared to standard-of-care preventive drugs or CGRP-targeting monoclonal antibodies can not be answered yet based on the available literature data.
- |||||||||| Trudhesa (dihydroergotamine mesylate intranasal) / Impel Pharma
Assessment of the Potential for Drug (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_3980; No clinically relevant DDIs from inhibition of, or being a substrate for, transporter proteins by gepants or DHE are anticipated because of limited data, but cannot be excluded. Conclusions Based on available data, no DDIs of clinical concern are predicted when recommended clinical doses of INP104 and gepants are coadministered.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie
Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_3814; P3 Background The PRODROME trial assessed the efficacy, safety, and tolerability of ubrogepant vs placebo in preventing the onset of moderate or severe headache when administered during the prodrome...For each participant, a mean (median) of 84.4% (100%) of their qualifying prodrome events were followed by a headache within 1-6 hours, with 76.9% of participants identifying qualifying prodrome events that were followed by headache within 1-6 hours ?75% of the time. Conclusions Participants were able to identify migraine attacks in which prodromal symptoms were reliably followed by headache within 1-6 hours.
- |||||||||| Opioid Use Among Migraine Patients Treated with Acute and Preventive Treatment () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_313;
The study assesses the real-world opioid utilization among migraine patients initiating on newer acute (ubrogepant, rimegepant, lasmiditan) and preventive (galcanezumab, erenumab, fremanezumab) migraine therapies and on standard of care (triptans). These findings suggest continued opioid use among migraine patients treated with both newer acute and preventive therapies and standard of care, highlighting the potential unmet pain management need for these patients.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie, Nurtec ODT (rimegepant ODT) / Pfizer
Retrospective data, Review, Journal: Ubrogepant and Rimegepant: Systematic Review, Meta-Analysis, and Meta-Regression of Clinical Studies. (Pubmed Central) - Feb 27, 2023 For rimegepant, significant correlations were observed between age and infections and having aura symptoms at baseline and nausea/dizziness/diarrhea/muscle strain. This study provided pooled incidence estimates of ubrogepant and rimegepant's ADRs and highlighted new safety aspects of the pharmacological treatment with ubrogepants and rimigepants from correlations obtained from the meta-regression.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie, Reyvow (lasmiditan) / Eli Lilly, Daiichi Sankyo, Nurtec ODT (rimegepant ODT) / Pfizer
Retrospective data, Review, Journal: Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature. (Pubmed Central) - Feb 14, 2023 Ubrogepant had overall the best tolerability profile. These conclusions are limited by the absence of head-to-head comparisons, limitations of individual trials and of the meta-analysis methodology itself.PROSPERO trial registration: CRD42022308224.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie
Enrollment open, Trial completion date, Trial primary completion date: UNION: Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies (clinicaltrials.gov) - Feb 8, 2023 P4, N=164, Recruiting, These conclusions are limited by the absence of head-to-head comparisons, limitations of individual trials and of the meta-analysis methodology itself.PROSPERO trial registration: CRD42022308224. Not yet recruiting --> Recruiting | Trial completion date: Mar 2023 --> Aug 2023 | Trial primary completion date: Jan 2023 --> Apr 2023
- |||||||||| Ubrelvy (ubrogepant) / AbbVie, Reyvow (lasmiditan) / Eli Lilly, Daiichi Sankyo, Nurtec ODT (rimegepant ODT) / Pfizer
Review, Journal, Real-world evidence, Real-world: Long-term open-label and real-world studies of lasmiditan, ubrogepant, and rimegepant for the acute treatment of migraine attacks. (Pubmed Central) - Feb 6, 2023 Not yet recruiting --> Recruiting | Trial completion date: Mar 2023 --> Aug 2023 | Trial primary completion date: Jan 2023 --> Apr 2023 Long-term and real-world data of tolerability, safety and efficacy of lasmiditan, ubrogepant, and rimegepant is thus far consistent with prior studies, but more longitudinal data that clarifies long-term safety as well as consistency and predictors of response is needed.
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