Ubrelvy (ubrogepant) / Merck (MSD), AbbVie - LARVOL DELTA

AbbVie Beats on Q2 Earnings & Sales, Stock Up on Raised '25 EPS View (Yahoo Finance) - "Sales from the neuroscience portfolio increased 24% to $2.68 billion, driven by higher sales of Botox Therapeutic, depression drug Vraylar and migraine drugs Ubrelvy and Qulipta. Neuroscience sales beat the Zacks Consensus Estimate and our model estimate of $2.47 billion and $2.48 billion, respectively. While Botox Therapeutic sales rose 14.2% to $928 million, sales of Vraylar increased 16.3% to $900 million. Sales of Ubrelvy totaled $338 million, up 47.2%. Qulipta sales increased 76.9% to $267 million. Sales of Vyalev, the recently approved transformative therapy for advanced Parkinson’s disease, totaled $98 million, compared with $63 million in the first quarter."

Sales • Depression • Migraine • Pain • Parkinson's Disease

Situational Prevention of Migraine Attacks: Can Early Treatment Change the Conversation? (PubMed, Drugs) - "A study of ubrogepant used during prodrome showed improved prodrome symptoms and reduced the chances of proceeding to the headache phase of migraine compared with placebo...In this article, we discuss the data available on treating migraine attacks early, both during prodrome phase and for the situational prevention of migraine during predictable triggers. Further clinical and real-world data are needed to continue to explore this concept and provide better management options for patients."

Journal • Review • CNS Disorders • Fatigue • Migraine • Musculoskeletal Pain • Pain

Comparative Efficacy of Over-the-Counter versus Oral Prescription Medications for Acute Treatment of Episodic Migraine – A Meta-Analysis (PAINWeek 2025) - "Background: Oral over-the-counter (OTC) analgesics such as acetaminophen-aspirin-caffeine (AAC) and ibuprofen (IBU) are widely used as first-line treatments for episodic migraine. Recently approved oral prescription (Rx) agents including gepants (ubrogepant [UBR], rimegepant [RIM]) and a selective 5-HT1F agonist lasmiditan (LAS), offer alternative options... Thirty two studies evaluating OTC and Rx oral treatments for episodic migraine were included in the meta-analysis. All active treatments were superior to placebo across pain and associated symptom endpoints. For two-hour pain relief, the highest efficacy was observed with ibuprofen 400–600 mg (RR: up to 2.21) and AAC (RR: 1.77)."

Retrospective data • CNS Disorders • Migraine • Pain

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17) (clinicaltrials.gov) - P3 | N=1200 | Enrolling by invitation | Sponsor: AbbVie | Trial completion date: May 2027 ➔ Jan 2028 | Trial primary completion date: May 2027 ➔ Jan 2028

Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain • Pediatrics

Ubrelvy: Newly added patent in Orange Book (Orange Book) - Expiry on Jan 30, 2035

Patent • Migraine

Early Experience Treating Vestibular Migraine with Small Molecule CGRP Antagonists (AAO-HNSF 2025) - "The gepants used included ubrogepant, rimegepant, atogepant, and zavegepant. Gepants can be effective medications for the treatment of vestibular migraine."

CNS Disorders • Migraine • Otorhinolaryngology • Pain • Vertigo

Adverse events associated with gepants: a pharmacovigilance analysis based on the FDA adverse event reporting system. (PubMed, J Headache Pain) - "The present pharmacovigilance study systematically revealed the significant risk signals of gepants. The common AEs and unique AEs of the four gepants were also identified and explored. Our results would provide valuable reference for the safe use of gepants, guiding personalized drug selection in clinical practice."

Adverse events • Journal • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Evaluation of unmet needs and quality-of-care indicators among patients with migraine in the United States: 2021–2022 (AHS 2025) - "Following migraine QOC indicators selected based on current literature were assessed among diagnosed migraine patients: (1) migraine-related healthcare visits: emergency department (ED), urgent care, neurology, primary care, outpatient, inpatient hospitalizations in each full calendar year, and 30-day hospital readmission following the first hospitalization; (2) medication use: acute (generic [triptans, opioids, NSAIDs, ergotamines, barbiturates, and acetaminophen] and branded [Ubrogepant, Zavegepant, Lasmiditan, Rimegepant (when the first prescription is for less or equal to 8 pills)]) and preventive (oral migraine preventive medications[OMPM; anticonvulsants, antidepressants, antihypertensives, and other oral combination medications] and branded [CGRP mAbs, Botox, Atogepant, Rimegepant (when the first prescription is for >8 pills)]) migraine treatments; (3) other migraine-related diagnoses: acute medication overuse (AMO) based on medication utilization algorithm and..."

Clinical • CNS Disorders • Migraine • Pain

Impact of triptan insufficient response on medication use, health care utilization, and costs: A retrospective claims study (AHS 2025) - "Substantial non-triptan acute use was observed among TIR patients over the 24-month follow-up period: migraine-related NSAIDs (48%), opioids (36%), and barbiturates (18%) as well as rimegepant (18%) and ubrogepant (16%). When compared with triptan continuers, a potential insufficient response to triptans was associated with significantly higher migraine-related HCRU, and costs."

HEOR • Retrospective data • CNS Disorders • Migraine • Pain

Real world survey of patient-reported gepant acute responses and usages (AHS 2025) - "We describe the real-world usage and effectiveness of gepants as acute treatments in current and prior users at a tertiary headache center. Rimegepant and ubrogepant users reported similar response consistency across acute effectiveness measures. Current users in both groups reported oral triptans as less effective than gepants, although fewer prior gepant users reported oral triptans as less effective."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine • Pain

Real-world effectiveness, treatment optimization, and satisfaction of ubrogepant for the acute treatment of migraine in individuals taking atogepant for the preventive treatment of migraine: Results from the COURAGE II study (AHS 2025) - "Real-world use of ubrogepant for acute treatment was effective when used in combination with atogepant for preventive treatment as indicated by high rates of meaningful pain relief and restoration of function within 4h, significant association with experiencing acute treatment optimization, and high rates of treatment satisfaction. No new safety signals were identified. Percentage of ubrogepant-treated migraine attacks for which meaningful pain relief (MPR) and return to normal function (RNF) within 2 and 4 h was reported in respondents who used atogepant concomitantly for the preventive treatment of migraine."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Migraine • Pain

Ubrogepant efficacy and safety in the acute treatment of migraine in patients currently treated with CGRP monoclonal antibodies (AHS 2025) - "Ubrogepant maintains comparable efficacy and safety profiles regardless of concurrent CGRPmAb use. These findings support its role as an acute migraine treatment for patients already on preventive CGRPmAb therapy. Future studies should explore long-term outcomes and potential interactions between these treatments."

Clinical • CNS Disorders • Migraine • Pain

Ubrogepant alleviates migraine premonitory symptoms. (PubMed, Nat Rev Neurol) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Migraine Drug Ubrogepant May Ease Preheadache Symptoms. (PubMed, JAMA) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Expert consensus on gepants for acute and preventive treatment of migraine in Thailand. (PubMed, J Headache Pain) - No abstract available

Journal • Review • CNS Disorders • Migraine • Pain

ATOM: Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (clinicaltrials.gov) - P4 | N=8 | Terminated | Sponsor: Messoud Ashina, MD | N=645 ➔ 8 | Recruiting ➔ Terminated; Issues with recruitment

Enrollment change • Trial termination • CNS Disorders • Migraine • Pain

Milk and plasma pharmacokinetics of single-dose ubrogepant in healthy lactating women. (PubMed, Headache) - P1 | "Less than 0.02 mg of a 100 mg dose of ubrogepant was excreted in breast milk over a 24-h period. The minimal transfer of ubrogepant into breast milk is not considered clinically relevant."

Journal • PK/PD data • CNS Disorders • Migraine • Pain

Comparative Risk of Major Adverse Cardiovascular Events among Patients who Initiate Treatment with Acute Migraine Agents (ISPOR 2025) - "Our study found that ubrogepant and rimegepant were associated with a lower risk of MACE compared to sumatriptan highlighting their potential as safer alternatives for patients with cardiovascular risk. No significant difference in MACE risk was observed between lasmiditan and sumatriptan suggesting the need for further research to better understand the cardiovascular safety profile of lasmiditan."

Adverse events • Clinical • Cardiovascular • CNS Disorders • Migraine • Myocardial Infarction • Pain

Ubrogepant relieves early migraine symptoms and may help prevent full-blown attacks (Medical News) - P3 | N=518 | UBR Prodrome (NCT04492020) | Sponsor: AbbVie | "The exploratory efficacy analysis, for which the paper provides precise percentages, odds ratios, and confidence intervals, revealed an absence of light sensitivity in approximately 19% and 12% of ubrogepant- and placebo-treated events, respectively, at 2-hour post-treatment; an absence of fatigue in approximately 27% and 16% and an absence of neck pain in approximately 28% and 15% of ubrogepant- and placebo-treated events, respectively, at 3-hour post-treatment; an absence of sound sensitivity in approximately 50% and 35% of respective events at 4-hour post-treatment; and an absence of dizziness in approximately 88% and 82% of respective events at 24-hour post-treatment."

P3 data • Migraine

Mechanistic role of pyroptosis in Kawasaki disease: An integrative bioinformatics analysis of immune dysregulation, machine learning-based biomarker discovery, WGCNA, and drug repurposing insights. (PubMed, PLoS One) - "Furthermore, drug repurposing analysis and molecular docking simulations suggested that Atogepant, Ubrogepant, and Zanubrutinib could serve as potential therapeutic candidates targeting S100A12 and MYD88. These findings provide novel insights into the molecular pathogenesis of KD and highlight potential biomarkers and therapeutic targets for improving KD diagnosis and treatment strategies."

Biomarker • Journal • Cardiovascular • Heart Failure • Inflammation • Vasculitis • MYD88 • S100A12

Ubrogepant for the treatment of migraine prodromal symptoms: an exploratory analysis from the randomized phase 3 PRODROME trial. (PubMed, Nat Med) - "At 1 h and 6 h post-dose, respectively, absence of difficulty concentrating occurred in 8.7% and 2.1% (OR = 4.26 (95% CI = 1.17-15.54)) and absence of difficulty thinking occurred in 56.9% and 41.8% (OR = 2.05 (95% CI = 1.14-3.71)) of events. Treatment with ubrogepant during the prodromal phase may ameliorate common prodromal symptoms, with improvements possibly as early as 1 h post-dose."

Journal • P3 data • CNS Disorders • Fatigue • Migraine • Musculoskeletal Pain • Pain

A 2-Part, Open-Label, Phase 1 Bioequivalence and Food-Effect Study of Ubrogepant in Healthy Adult Participants. (PubMed, Clin Pharmacol Drug Dev) - "The occurrence of treatment-emergent adverse events was low, and the majority were mild. Ubrogepant TBM and CT tablets (1 × 100 mg or 2 × 50 mg) were bioequivalent under fasted conditions, and a high-fat meal had no clinically relevant effect on the bioavailability of the TBM tablet formulation."

Journal • P1 data • CNS Disorders • Migraine • Pain

AbbVie Reports First-Quarter 2025 Financial Results (PRNewswire) - "Global net revenues from the neuroscience portfolio were $2.282 billion, an increase of 16.1 percent on a reported basis, or 17.0 percent on an operational basis. Global Vraylar net revenues were $765 million, an increase of 10.3 percent. Global Botox Therapeutic net revenues were $866 million, an increase of 15.8 percent on a reported basis, or 17.0 percent on an operational basis. Global Ubrelvy net revenues were $240 million, an increase of 17.8 percent on a reported basis, or 18.0 percent on an operational basis. Global Qulipta net revenues were $193 million, an increase of 47.6 percent on a reported basis, or 48.3 percent on an operational basis."

Sales • Bipolar Disorder • Major Depressive Disorder • Migraine • Pain • Schizophrenia

A fixed-dose combination of meloxicam and rizatriptan (Symbravo) for migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Head-to-head relief: ubrogepant, rimegepant, and zavegepant in migraine treatment. (PubMed, Pain Manag) - "The NNT values for achieving pain freedom at two hours were 9 for rimegepant, 11 for zavegepant, and 12 for ubrogepant, which are comparable to NSAIDs such as naproxen (NNT = 11). Triptans demonstrated lower NNTs, indicating higher efficacy. Gepants offer effective, well-tolerated alternatives with no significant cardiovascular risk and minimal potential for medication-overuse headache."

Head-to-Head • Journal • Review • Cardiovascular • CNS Disorders • Migraine • Pain