Research question and objectives Primary endpoint
• To evaluate the effectiveness of Rimegepant in the acute treatment of migraine as measured by most severe pain, onset of pain relief, satisfaction with pain relief, and satisfaction with return to normal function post-dose.
Secondary Objectives
To evaluate the effectiveness of Rimegepant in the acute treatment of migraine as measured by onset of associated symptoms relief.
To evaluate the long-term effect of Rimegepant treatment on the treatment satisfaction and global impression of change at months 3，6 and 12.
Exploratory Objective
To evaluate the long-term effectiveness of Rimegepant by evaluating the changes from baseline in any decrease in MMD with any intensity in those participants with baseline MMD ≥6 days.
To evaluate the long-term effectiveness of Rimegepant by evaluating the changes from baseline of any decrease of MHD.
To evaluate the long-term effectiveness of Rimegepant by evaluating any decrease of mean number of moderate to severe migraine days per month in those participants with baseline MMD ≥6 days
To evaluate the changes from baseline in the percentage of MOH and chronic migraine transformation to episodic migraine during Rimegepant long-term (PRN) use.
To evaluate the changes from baseline of Rimegepant usage, other migraine-related medication usage and MO during Rimegepant long-term (PRN) use.
To evaluate the changes from baseline on quality of life, function, depression and anxiety at months 3, 6 and 12.
To evaluate the association between the timing of Rimegepant dosing (dosing at pain free while with any prodrome symptoms/ dosing at pain free while with any aura symptoms / dosing at mild pain/ dosing at moderate pain/ dosing at severe pain) and the acute treatment effectiveness of Rimegepant.
To evaluate the acute treatment effectiveness of Rimegepant in migraine participants with a history of insufficient response or intolerable to NSAIDs /Triptans /Combination analgesic.
To evaluate the acute treatment effectiveness of combination use of Rimegepant plus NSAIDs/Triptans/Combination analgesic in participants with insufficient response to monotherapy.
To evaluate the acute treatment effectiveness of Rimegepant in migraine participants with prior treatment failure of more than two triptans.
Study design This is a single arm, prospective, multi-center, observational registry study with participants receiving Rimegepant for the acute treatment of migraine in a real-world setting. Each participant will receive treatment and care according to standard clinical practice.
About 3,000 adult migraine participants will be enrolled continuously at 70 to 73 sites with a headache clinic or headache center in China in approximately 16 consecutive months or until reaching the target sample size.. The index date for a participant will be the date of enrollment. The maximum follow-up period per participant after enrollment is 12 months.
At the Baseline Visit, the demographics information, socioeconomic characteristics, and medical and migraine history will be collected from the enrolled participants. For the acute treatment effectiveness evaluation, data on Rimegepant treating single migraine attack including the timing of dosing, most severe pain, onset time of pain relief, onset time of associated symptoms relief, satisfaction with pain relief and satisfaction with function improvement are expected to be captured within 3 months after enrollment through a digital platform. If none of these data are captured within 3 months, the participant will be marked as failed in the study and will not be followed up further. For the long-term effectiveness evaluation, participants will use an eDiary to record headache and migraine occurrence, and use a digital platform to collect Rimegepant and other migraine-related medication usage days every month. At study visits, participants will complete the Migraine-Specific Quality-of-Life Questionnaire (MSQ) v2.1, Migraine Disability Assessment (MIDAS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder -7 (GAD-7), Patient Global Impression of Change (PGI-C) and the Satisfaction with Medication (SM) scale at months 3, 6 and 12 via electronic patient reported outcomes (ePROs). The previous four scales will be completed by participants at baseline visit.

Start Date01 Aug 2024

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

NCT06221111 / RecruitingPhase 2

Rimegepant, a CGRP Antagonist, in the Treatment of Visceral Sensation and Chronic Abdominal Pain: A Pilot Study

The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.

Start Date06 Jun 2024

Sponsor / Collaborator

Mayo Clinic

[+1]

NCT06212661 / Enrolling by invitationNot Applicable

Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Start Date05 Apr 2024

Sponsor / Collaborator

The Cleveland Clinic Foundation

100 Clinical Results associated with Rimegepant Sulfate

100 Translational Medicine associated with Rimegepant Sulfate

100 Patents (Medical) associated with Rimegepant Sulfate

144

Literatures (Medical) associated with Rimegepant Sulfate

01 Feb 2024·Neurology and therapy

Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial

Article

Author: Pandey, Hitendra ; Goadsby, Peter J ; Schwedt, Todd J ; Pearlman, Eric M ; Varnado, Oralee J ; Vargas, Bert B ; Richardson, Diane R ; Martinez, James M ; Cobas Meyer, Michael ; Myers Oakes, Tina M

INTRODUCTION:

There have been no prior trials directly comparing the efficacy of different calcitonin gene-related peptide (CGRP) antagonists for migraine prevention. Reported are the results from the first head-to-head study of two CGRP antagonists, galcanezumab (monoclonal antibody) versus rimegepant (gepant), for the prevention of episodic migraine.

METHODS:

In this 3-month, double-blind, double-dummy study, participants were randomized (1:1) to subcutaneous (SC) galcanezumab 120 mg per month (after a 240 mg loading dose) and a placebo oral disintegrating tablet (ODT) every other day (q.o.d.) or to rimegepant 75 mg ODT q.o.d. and a monthly SC placebo. The primary endpoint was the proportion of participants with a ≥ 50% reduction in migraine headache days per month from baseline across the 3-month double-blind treatment period. Key secondary endpoints were overall mean change from baseline in: migraine headache days per month across 3 months and at month 3, 2, and 1; migraine headache days per month with acute migraine medication use; Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive domain score at month 3; and a ≥ 75% and 100% reduction from baseline in migraine headache days per month across 3 months.

RESULTS:

Of 580 randomized participants (galcanezumab: 287, rimegepant: 293; mean age: 42 years), 83% were female and 81% Caucasian. Galcanezumab was not superior to rimegepant in achieving a ≥ 50% reduction from baseline in migraine headache days per month (62% versus 61% respectively; P = 0.70). Given the pre-specified multiple testing procedure, key secondary endpoints cannot be considered statistically significant. Overall, treatment-emergent adverse events were reported by 21% of participants, with no significant differences between study intervention groups.

CONCLUSIONS:

Galcanezumab was not superior to rimegepant for the primary endpoint; however, both interventions demonstrated efficacy as preventive treatments in participants with episodic migraine. The efficacy and safety profiles observed in galcanezumab-treated participants were consistent with previous studies.

TRIAL REGISTRATION:

ClinTrials.gov-NCT05127486 (I5Q-MC-CGBD).

01 Jan 2024·Handbook of clinical neurology

CGRP monoclonal antibodies and CGRP receptor antagonists (Gepants) in migraine prevention

Review

Author: Alpuente, Alicia ; Pozo-Rosich, Patricia ; Caronna, Edoardo ; Torres-Ferrus, Marta

Migraine is a prevalent and disabling neurological disease. Its preventive treatment for decades has been rather limited due to the absence of disease-specific therapies with limited efficacy and tolerability. The advances made in migraine research have led to the discovery of the calcitonin gene-related peptide (CGRP) and its role in migraine pathophysiology. CGRP is a neuropeptide that acts as potent vasodilator and is involved in pain processing. Increased levels of plasma CGRP have been observed during migraine attacks as well as interictally when comparing patients with migraine and healthy controls. In the last years, two classes of drugs antagonizing CGRP have therefore been developed as the first migraine-specific preventive treatments: anti-CGRP monoclonal antibodies (mAbs) and gepants. Four mAbs have been approved: erenumab, galcanezumab, fremanezumab, and eptinezumab. Gepants are small molecules that antagonize the CGRP receptor; currently only rimegepant and atogepant have been approved for migraine prevention. These new drugs have demonstrated efficacy and safety in clinical trials for both episodic and chronic migraine, and results from their real-world experience are being increasingly reported in literature. In this review, we provide an overview of anti-CGRP drugs and their placement in migraine prevention.

01 Jan 2024·Revista de neurologia

Review

Author: Quintas, S ; Irimia, P ; Mínguez-Olaondo, A ; Díaz-Insa, S ; Layos-Romero, A ; Belvís, R ; López-Bravo, A ; Nieves-Castellanos, C

Treatment of migraine attacks is advised in all patients, using non-steroidal anti-inflammatory drugs when the pain is mild and triptans when the pain intensity is moderate-severe. However, the effectiveness of these drugs is moderate, a high percentage of patients have side effects, and triptans are contraindicated in people with a history of stroke, ischaemic heart disease or poorly controlled hypertension. Hence, there is an urgent need for new therapeutic alternatives. In recent years, new drugs for migraine attacks have become available, most notably ditans (lasmiditan) and gepants (ubrogepant and rimegepant). Furthermore, eptinezumab, which has been approved for the preventive treatment of migraine in adults, has also been used for migraine attacks. This manuscript reviews the efficacy and safety results of the new drugs for migraines that will soon be on the market.

News (Medical) associated with Rimegepant Sulfate

30 Apr 2024

·www.prnewswire.com

Enlyte Drug Trends Report Indicates Significant Drop of Opioid Use in Comp

Overall opioid utilization down nearly 10%; sustained-release opioids drop by over 10% SAN DIEGO, April 30, 2024 /PRNewswire/ -- Efforts by workers' comp regulators and professionals to control opioid prescriptions and distribution are resulting in one of the largest drops in utilization the workers' comp industry has seen in years, according to researchers who published part one of Enlyte's 2024 Annual Pharmacy Solutions Drug Trends Report today. Each year Enlyte researchers analyze drug utilization and spending trends in workers' comp to provide the industry with new insights in pharmacy management. Enlyte's 2024 series reflects on trends clients experienced in 2023, with an overview of both in- and out-of-network prescriptions. Among opioid categories, the report indicates decreases in utilization, including sustained-released opioids, which dropped by more than 10% in 2023, as supported by prescribing guidelines. Enlyte's data also shows overall opioid usage per claim dropped by nearly 10%, while cost per claim decreased by more than 7%. "This, by far, marks one of the largest drops in opioid utilization we've seen in years," said Nikki Wilson, PharmD, MBA, senior director, clinical pharmacy solutions. "In addition, opioid alternatives commonly prescribed to manage acute and chronic pain also experienced decreases in utilization per claim, although to a lesser degree than opioids." Researchers also noted per claim drops in overall drug cost and utilization in workers' comp among therapeutic classes ranked by cost in 2023. Though eight of the top 10 therapeutic classes experienced increased costs per script — with two classes rising by more than 10% — utilization per claim fell in every class except migraine medications, which jumped 17%. The largest script cost increases were within the respiratory and migraine medication classes at 14.7% and 10.2%, respectively, and both classes were among the top five therapeutic classes to experience brand average wholesale price increases in 2023, which likely contributed to the rising cost per script, said Wilson. "Basically, what's driving these trends are the costs of the top three medications in their respective classes," she said. "For instance, for migraine medications, Nurtec ODT is prescribed about 15% of the time yet makes up more than 31% of the total drug spend in this category. Similarly, respiratory medication like Trelegy Ellipta is prescribed about 10%, but accounts for nearly 19% of all respiratory medication total costs." Additionally, Enlyte data shows that retail and mail order prescriptions are trending downward with utilization per claim falling by more than 5% and cost per claim down by 0.2%. However, costs per script continue to rise, increasing from last year's report by 5.2%. To access part 1 of Enlyte's drug trends report, click here. About Enlyte Headquartered in San Diego, CA, Enlyte () is the parent company of Mitchell, Genex and Coventry, leaders in cost-containment technology, independent medical exams (IME), provider and specialty networks, case management services, pharmacy benefit and disability management. The Enlyte businesses align their joint industry expertise and advanced technology solutions in a combined organization of nearly 6,000 associates committed to simplifying and optimizing property, casualty and disability claims processes and services. SOURCE Enlyte

11 Apr 2024

·www.pharmaceutical-technology.com

UK’s NICE recommends AbbVie’s Aquipta to treat migraines

According to GlobalData, the migraine drugs market is set to be worth $18.6bn in 2030 globally. Credit: Krakenimages.com via Shutterstock. The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered a substantial decline in mean monthly migraine days from baseline to 12 weeks. The treatment also provided decline from baseline in mean monthly headache days and acute medication days. This list price of Aquipta is £463.38 for 28 tablets, with the medication set to be made available on the NHS from next month. However, at first it will only be available from specialist doctors in secondary care settings, rather than from GPs. See Also: MorphoSys gets grant for novel compounds for treating diseases associated with methyl modifying enzymes Laboratorios Farmaceuticos Rovi gets grant for injectable composition for treating cancer, especially breast cancer The US Food and Drug Administration (FDA) first approved the treatment for episodic migraines in September 2021, but AbbVie expanded the drug’s label to include chronic migraines in April 2023. The drug’s European brand name is Aquipta but it is sold under the name Qulipta in Canada and the US. According to GlobalData’s Pharma Intelligence Center, Aquipta is forecast to generate $1.56bn in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology. Migraines are intense throbbing headaches, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. Chronic migraines involve experiencing headaches on 15 or more days per month, with at least eight of those headaches meeting the criteria for migraine. Episodic migraines, on the other hand, occur less frequently, typically fewer than 15 days per month. Distinct migraine attacks last four to 72 hours if left untreated. According to GlobalData, the migraine market is set to be worth $18.6bn in 2030 globally. In June 2023, NICE also recommended Pfizer’s Vydura (rimegepant) to prevent episodic migraine attacks.

Phase 3Drug ApprovalClinical Result

04 Apr 2024

·www.biospace.com

NURTEC ODT is Now Available in Canada for the Treatment of Acute Migraine

More than one billion people worldwide live with migraine,i and the World Health Organization classifies migraine as the second leading cause of disability in the world.ii KIRKLAND, QC, April 4, 2024 /CNW/ - NURTEC ODT® (rimegepant) is now available in Canada for use in the acute treatment of migraine, with or without aura in adults older than 18 years of age.iii NURTEC is an orally disintegrating calcitonin gene-related peptide (CGRP) receptor antagonist tablet. It was approved by Health Canada on December 1, 2023. Classified as one of the 10 most disabling medical illnesses in the world,iv migraine is a brain disease characterized by attacks that last from four to 72 hours with multiple symptoms including, pulsating moderate to severe headache, sensitivity to light and sound, nausea and sometimes vomiting, as well as cognitive fogginess, amongst other symptoms.v "Migraine is a common, disabling brain disease, and for those living with migraine, effective therapy can take years to be found," said Dr. Christine Lay, Professor of Neurology and Founding Director of the Headache Program at the University of Toronto. "It is an exciting time for Canadians to now have another targeted, migraine specific therapy in their management toolbox." An estimated 4.5 million Canadians suffer from migraine with one in four households having someone affected by the disease.vi In Canada, migraine is a leading cause of years lived with disability among those aged 15 to 49 years. vii "Migraine symptoms are complex and may last for several days. People living with migraine are looking for timely and equitable access to new options to effectively manage this highly debilitating disease," said Wendy Gerhart from Migraine Canada. "We are excited for new treatments to help advance migraine care, which is often overlooked, underdiagnosed, and undertreated." "Pfizer Canada is proud to bring this new therapy to Canadians impacted by migraine," said Andréa Mueller, Primary Care Portfolio Lead, Pfizer Canada. "Pfizer has a long-standing legacy in managing neurological conditions, and we are proud to build on our commitment in this area with our work in the treatment of migraine." About Migraine Migraine is the third most prevalent illness in the world,viii affecting around 1.3 billion people globally.ix Migraine prevalence is highest during peak employment years.x In Canada, migraine is the third-leading cost driver for incremental productivity loss due to absenteeism and presenteeism.xi,xii While migraine affects all demographics, women are disproportionately impacted by this brain disease.xiii About NURTEC ODT® NURTEC ODT targets a key component of migraine by reversibly blocking calcitonin gene-related peptide (CGRP) receptors. CGRP is increased during a migraine attack, promotes neurogenic inflammation, dilates blood vessels and is involved in nociceptor signaling. CGRP receptor antagonists work by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the endogenous CGRP neuropeptide. CGRP receptors are a key contributor to the trigeminal nerve pain and inflammation of migraine.xiv About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. At Pfizer, we apply science and our global resources to bring therapies to people that help extend and improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, Pfizer has worked to make a difference for all who rely on us. Global headquarters are located in New York City, where the company was founded in 1849. Pfizer's Canadian footprint includes its headquarters in Kirkland, Quebec and a manufacturing site in Brandon, Manitoba. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, X, Instagram or YouTube. SOURCE Pfizer Canada Inc.

Drug Approval

100 Deals associated with Rimegepant Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Rimegepant Sulfate	N02C	DB12457

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Migraine Disorders	US	Pfizer Inc.	27 Feb 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Migraine With Aura	Phase 3	US	Pfizer Inc.	28 Apr 2021
Migraine With Aura	Phase 3	PL	Pfizer Inc.	28 Apr 2021
Migraine With Aura	Phase 3	ES	Pfizer Inc.	28 Apr 2021
Acute migraine	Phase 3	CN	Bioshin Ltd.	22 Oct 2020
Acute migraine	Phase 3	CN	Pfizer Inc.	22 Oct 2020
Acute migraine	Phase 3	KR	Bioshin Ltd.	22 Oct 2020
Acute migraine	Phase 3	KR	Pfizer Inc.	22 Oct 2020
Migraine Without Aura	Phase 3	US	Pfizer Inc.	18 Jul 2017
Plaque psoriasis	Phase 2	US	Weill Medical College of Cornell University	19 Jan 2021
Plaque psoriasis	Phase 2	US	Pfizer Inc.	19 Jan 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03941834 (BHV3000-202, CTgov)	Phase 2	Trigeminal Neuralgia	65	Rimegepant (DBT Phase: Pooled Rimegepant)	exkakmjfha(jonsbjwhaq) = uzfppltkdj jpzdkxwacr (kbibccuhoo, svkiogynoh - svfhfnxaat) View more	-	10 Jun 2024
				placebo+rimegepant (DBT Phase: Pooled Placebo)	exkakmjfha(jonsbjwhaq) = hizetfnjrk jpzdkxwacr (kbibccuhoo, wxltwuyhjv - tcgfygqhte) View more
NCT05262517 (CTgov)	Phase 3	Temporomandibular Joint Disorders	126	Rimegepant (BHV3000 (Rimegepant (BHV3000))	uceiugfmog(mlchmlklcz) = zmqbpnujdw fnzcuwgifv (dlwjzeuesp, jpxcqhdzdn - eykugdldex) View more	-	16 May 2024
				placebo+rimegepant (Placebo)	uceiugfmog(mlchmlklcz) = nrkdgzlnel fnzcuwgifv (dlwjzeuesp, serjrpggmp - fzopnjfjlo) View more
NCT04574362 (Pubmed)	Phase 3	Migraine Disorders	1,075	Rimegepant ODT 75 mg	bcmjempqiw(tizpoiwoay) = vwbyuqtsay lrldiynumc (tjbthrnybj ) View more	Positive	16 Apr 2024
				Placebo	bcmjempqiw(tizpoiwoay) = wxydvrmbgd lrldiynumc (tjbthrnybj ) View more
NCT03266588 (Pubmed)	Phase 2/3	Migraine Disorders calcitonin gene-related peptide receptor	1,800	Rimegepant 75 mg PRN 2-8	pbpardpdgo(ylyaexmxcs) = 6.8% iuzszqsmgh (npnxdunnta ) View more	Positive	01 Apr 2024
				Rimegepant 75 mg PRN 9-14
NCT04574362 (BHV3000-310, CTgov)	Phase 3	Acute migraine	1,648	Placebo	wynwxpsdmy(mohlkhbamk) = lvejuovfzq ezncyvvvqi (watnzpwfde, jvpmgydked - fneksigfab) View more	-	14 Dec 2023
NCT04574362 (BHV3000-310, Pubmed)	Phase 3	Migraine Disorders	1,431	Rimegepant 75 mg	juypiqxult(wmecsmfpgv) = 7 [1%] of 668 vs 18 [3%] of 674 msqyrsvyrx (zonkxmaarz ) View more	-	01 Jun 2023
				Placebo
P9-12.009 (AAN2023)	Not Applicable	Migraine Disorders	3,551	Rimegepant 75 mg	gxqakthvmp(xmcvhzizrc) = ibiwzgkwsv nvuxmffuxc (tvbhcahupd ) View more	Positive	25 Apr 2023
				Placebo	gxqakthvmp(xmcvhzizrc) = dxfxzrejbi nvuxmffuxc (tvbhcahupd ) View more
NCT03732638 (P12-12.006, AAN2023)	Phase 2/3	Migraine Disorders	741	Rimegepant 75 mg EOD	doyexpoycs(ygmeqxqzmx) = ehyjguebij rnewqolnbh (igrjuxpdlu )	Positive	25 Apr 2023
NCT03732638 (AAN2023)	Phase 2/3	Migraine Disorders	-	Rimegepant 75 mg	qvtxhgkepp(fdednwijke) = usybfuppbl qfcziavjnx (yyvmxngpph, 92.9 - 96.7) View more	-	25 Apr 2023
P10-12.010 (AAN2023)	Phase 2/3	Migraine Disorders	-	Rimegepant 75 mg	izbaxpigeb(frsnvvojrc) = cljsypdfht wrmpalclaf (todudqzkka ) View more	-	25 Apr 2023

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