rimegepant (BHV-3000) / BMS, Pfizer - LARVOL DELTA

Network Meta-Analysis Comparing Efficacy and Safety Outcomes of Atogepant, Rimegepant, and Galcanezumab in Patients with Episodic Migraine After Including CHALLENGE-MIG Trial (AAN 2025) - "Objective:Network meta-analysis (NMA) of atogepant (Ato) relative to rimegepant (Rime) and galcanezumab (Galc) after inclusion of the CHALLENGE-MIG trial for efficacy and safety outcomes in episodic migraine (EM) patients.Background:The NMA included 5 randomized, controlled trials for the preventive treatment of EM (ADVANCE [Ato 60 mg], BHV3000-305 [Rime 75 mg], EVOLVE-1, EVOLVE-2 [Galc 120 mg], and CHALLENGE-MIG [Rime 75 mg, Galc 120 mg]).Design/A fixed-effects model was chosen to compare the efficacy and safety of Ato versus Rime, Galc based on model fit statistics. Ato 60 mg demonstrated significant improvements in 3 of the 4 efficacy outcomes compared to Rime 75 mg and significantly increased odds of achieving ≥50% RR in MMD relative to Galc 120 mg. Other efficacy outcomes were not significantly different. Ato 60 mg demonstrated comparable all-cause d/c and TEAEs relative to Rime and Galc."

Retrospective data • CNS Disorders • Migraine • Pain

Cost per treatment responder analysis of atogepant compared to rimegepant for the preventive treatment of episodic migraine. (PubMed, Headache) - "Atogepant had substantially lower numbers needed to treat and costs per additional responder versus placebo than rimegepant for the preventive treatment of EM across all evaluated scenarios. These analyses suggest that atogepant may be more cost effective than rimegepant for the preventive treatment of EM. Limitations include differences in inclusion/exclusion criteria and in reporting of the ≥50% responder rates between trials."

Journal • CNS Disorders • Migraine • Pain

Monthly migraine days, tablet utilization associated with the real world use of rimegepant among Chinese adults (AHS 2024) - P, P2/3, P3 | "Rimegepant administered as needed (PRN) in patients with ≥6 MMDs was proved to be associated with reduced MMDs and monthly tablet utilization in two long-term safety studies (BHV3000-201, NCT03266588; BHV3000-318, NCT05371652)...Eligible patients with less than one dose of rimegepant, or treated with CGRP monoclonal antibodies or OnabotulinumtoxinA during 3 months of follow-up were excluded from this analysis... In this real-world analysis, rimegepant (PRN) can decrease the MMDs as early as first month and continued throughout the 3 months, and the number of rimegepant tablets administered/month also gradually declined during the treatment of 3 months."

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

Is the right way to go in between? : Rimegepant as needed provides preventive benefit. A comment on: monthly migraine days, tablet utilization, and quality of life associated with rimegepant-post hoc results from an open label safety study (BHV3000-201). (PubMed, J Headache Pain) - "The study by Johnston et al. provides food for thought along these lines and should encourage us to further investigate flexible patient-controlled CGRP blocking as a third, intermediate and potentially cost-effective avenue between acute/rescue treatment and prevention/prophylaxis."

HEOR • Journal • Retrospective data • CNS Disorders • Migraine • Pain

Efficacy, Safety of Rimegepant When Used Both as Preventively and As-Need: Richard B. Lipton, MD (NeurologyLive) - "'This study showed that in open-label, naturalistic, real-world settings, when people are given the opportunity to use rimegepant as both a preventive and acute treatment, they do it. They don't take rimegepant very often even when the drug is freely available, and that the safety and tolerability, as well as the long-term efficacy data, are encouraging.'"

Video

Managing migraine: gepants for acute and preventive treatment (VJNeurology) - "During recent neurology conferences, migraine experts have shared noteworthy developments regarding the use of gepants, including clinical trial results, potential new indications, and recent FDA submissions."

Audio

Future work on rimegepant for migraines (YouTube) - "Richard Lipton, MD...discusses important future work on rimegepant for the treatment of migraine. Since rimegepant became available as a preventive medication recently, researchers and clinicians are still learning to use it in clinical practice....This means there is a need for more data regarding drug-drug interactions between rimegepant and other oral medications. This interview took place during the 2022 American Headache Society (AHS) Annual Scientific Meeting in Denver, CO."

Video

Open-label extension study of rimegepant for acute and preventive migraine treatment (YouTube) - "Richard Lipton, MD...discusses an open-label extension study (NCT03732638) of rimegepant for preventive and acute migraine treatment....These results support the convenience of having a single drug that can be used in both settings. Rimegepant remains the only FDA-approved drug for acute and preventive treatment of migraine. This interview took place during the 2022 American Headache Society (AHS) Annual Scientific Meeting in Denver, CO."

Interview • Video

Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305). (PubMed, Adv Ther) - P2/3 | "Compared to placebo, treatment with rimegepant 75 mg was associated with greater improvement in EQ-5D utilities during the 12-week DBT phase. Patients originally randomized to placebo experienced a similar improvement in EQ-5D utilities after switching to rimegepant during the OLE, demonstrating that benefits are realized within 12 weeks of active treatment. This preventive effect was durable out to 64 weeks and was associated with an additional increase in HRQoL over time."

Journal • CNS Disorders • Migraine

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to study the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 years of age (clinicaltrialsregister.eu) - P3 | N=640 | Ongoing | Sponsor: Biohaven Pharmaceuticals Holding Company Limited

New P3 trial • CNS Disorders • Migraine

MSQ Utility Mapping of Rimegepant by Change in Monthly Migraine Days for Preventive Treatment of Migraine (AAN 2022) - P2/3 | "A recent multicenter, phase 2/3, randomized, double-blind, placebo-controlled trial (BHV3000-305; NCT03732638) found rimegepant to be effective for preventive treatment of migraine when taken every other day (EOD)...Patients were allowed to use acute headache treatments (including triptans, nonsteroidal anti-inflammatory drugs, acetaminophen, antiemetics) as needed... In comparison with placebo, Rimegepant 75mg is associated with greater improvement in MMDs and in EQ-5D utilities."

CNS Disorders • Migraine • Pain

Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201). (PubMed, J Headache Pain) - P2/3 | "For subjects with 6 or more MMD, acute treatment of migraine attacks with rimegepant 75 mg on a PRN basis over one-year of follow-up was found to be associated with reduced MMD frequency without an increase in monthly tablet utilization, and improved HRQoL. There was no evidence of medication-related increases in MMDs when rimegepant 75 mg was used as needed for the acute treatment of migraine over 52-weeks."

Clinical • HEOR • Journal • Retrospective data • CNS Disorders • Migraine • Pain

[VIRTUAL] Acute treatment with rimegepant 75 mg confers long term improvements in median time to 30% and 50% reductions in monthly migraine daysPost hoc results from an open label safety study (BHV3000-201) (AHS 2021) - P2/3 | "Repeated acute treatment of migraine with rimegepant 75 mg on a PRN basis, was associated with clinically relevant reductions in MMD without evidence of medication related increases in headache frequency. Discontinuation of rimegepant use for patients experiencing a higher reduction in MMDs may suggest "positive discontinuation" in which subjects with well managed disease choose to stop treatment. These findings are consistent with preventive benefits of rimegepant 75 mg demonstrated in placebo-controlled studies."

Clinical • CNS Disorders • Migraine • Pain

[VIRTUAL] Monthly migraine days, tablet utilization, and quality of life associated with rimegepantpost hoc results from an open label safety study (BHV3000-201) (AHS 2021) - P2/3 | "Ongoing acute treatment of migraine with rimegepant 75 mg on a PRN basis over one year of follow-up was found to be associated with reduced MMDs and a corresponding reduction in monthly tablet utilization. These data suggest that repeated PRN use of rimegepant did not lead to a trend indicative of medication overuse headache. Reduction in MMDs and use of rimegepant to treat the acute migraine episodes jointly resulted in improved HRQoL estimates."

Clinical • HEOR • CNS Disorders • Migraine • Pain

Matching-adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health-related quality of life in the treatment of migraine. (PubMed, Headache) - "When adjustments were made to reflect baseline characteristics in published literature, supporting data from BHV3000-201 suggest that rimegepant every other day is an effective therapy in reducing disability and MMDs and enhancing migraine-specific HRQoL. These data support the preventive benefit observed in randomized trials of rimegepant and further validate its efficacy for both acute and preventive treatment of migraine."

Clinical • HEOR • Journal • CNS Disorders • Migraine

[VIRTUAL] Acute Treatment with Rimegepant 75 mg Confers Clinically Relevant Improvement in Lost Time (Days) Due to Migraine: Results From a 1-Year, Open-Label Safety Study (BHV3000-201) (AAN 2021) - P2/3 | "Repeated long term treatment of acute migraine with rimegepant 75 mg was associated with clinically relevant improvements in days lost due to migraine. These improvements would likely contribute to better patient productivity due to reduced migraine-related disability."

Clinical • CNS Disorders • Migraine • Pain

[VIRTUAL] MATCHING-ADJUSTED INDIRECT COMPARISONS OF INTERMITTENT ORAL RIMEGEPANT VERSUS PLACEBO AND INJECTABLE ANTI-CGRP-TARGETED MONOCLONAL ANTIBODIES EXAMINING MONTHLY MIGRAINE DAYS IN THE TREATMENT OF MIGRAINE (AMCP 2021) - "Recent estimates from a single arm study (BHV3000-201) have also shown evidence of long-term preventive effects in MMD. Oral rimegepant was found to be superior to placebo and comparable to injectable galcanezumab and erenumab in reducing MMD. While a controlled trial would be the optimal methodology for assessing relative difference, the available data demonstrate that rimegepant may be effective in the prevention of migraine."

Clinical • CNS Disorders • Migraine

Evaluating rimegepant for the treatment of migraine. (PubMed, Expert Opin Pharmacother) - "Although current evidence on CGRP receptor blockade has shown no cardiovascular adverse events, clinicians should remain critical about the use of rimegepant, as well as other CGRP (receptor) inhibiting drugs. Further research should focus on determining the consequences of long-term CGRP blockade, especially during ischemia or cardiovascular disease, the exact receptors antagonized by rimegepant, and potential effects of combining rimegepant with other antimigraine treatments."

Journal • Cardiovascular • CNS Disorders • Migraine • Pain

Drugs for Migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Rimegepant in Moderate Plaque-type Psoriasis (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Weill Medical College of Cornell University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Psoriasis

Comparative Efficacy of Oral Calcitonin-Gene-Related Peptide Antagonists for the Treatment of Acute Migraine: Updated Meta-analysis. (PubMed, Clin Drug Investig) - "CGRP antagonists are more effective than placebo against acute migraine; however, further studies are required to consider CGRP antagonists as standard first-line treatment for acute migraine instead of triptans, especially in patients with co-existing cardiovascular diseases."

Retrospective data • Review • Cardiovascular • CNS Disorders • Migraine • Pain

Randomized Study in Children and Adolescents With Migraine: Acute Treatment (clinicaltrials.gov) - P3; N=1440; Recruiting; Sponsor: Biohaven Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Migraine

Novel synthetic treatment options for migraine. (PubMed, Expert Opin Pharmacother) - "Areas covered: This paper reviews the available data from RCTs to assess the clinical efficacy, safety, and tolerability profile of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine and atogepant for the prevention of migraine. On the contrary, the new generation of gepants showed a placebo-like tolerability profile and the absence of a specific pattern of side effects. Future studies on lasmiditan and gepants with respect to established effective comparators are mandatory to support phase III results and to help clinicians to balance the benefit/risk profiles of the various acute and preventive medications."

Journal • Cardiovascular • CNS Disorders • Migraine • Pain

Pharmacokinetics, Pharmacodynamics and Drug-Drug Interactions of New Anti-Migraine Drugs-Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies. (PubMed, Pharmaceutics) - "Lasmiditan, ubrogepant, rimegepant and monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) are new drugs that were launched on the US pharmaceutical market; some of them also in Europe. In the case of monoclonal antibodies, the issue of pharmacodynamic interactions related to the modulation of the immune system functions was addressed. It also focuses on the effect of monoclonal antibodies on expression of class Fc gamma receptors (FcγR)."

Journal • PK/PD data • Review • Breast Cancer • CNS Disorders • Migraine • Oncology • Solid Tumor

Pain Freedom at 2-8 Hours With Lasmiditan: A Comparison With Rimegepant and Ubrogepant: A Response. (PubMed, Headache) - No abstract available

Journal • Pain