AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE

The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.

Start Date24 Dec 2024

Sponsor / Collaborator

Pfizer Inc.

NCT06728345 / Not yet recruitingNot ApplicableIIT

The Real-world Study of Rimegepant for the Preventive Treatment in Female Migraine Patients

The goal of this observational study is to learn about the effects and safety of Rimegepant in women, especially young and middle-aged women, who take Rimegepant to treat their migraine in the real world. Participants already taking Rimegepant (75mg QOD) as their regular preventive treatment of migraine for 12 weeks will be evaluated as the followings :
1. To evaluate the change from baseline in the mean number of migraine days per month during weeks 1-12
2. To evaluate the number of participants that have least a 50% reduction from baseline in the mean number of migraine days per month during weeks 1-12

Start Date01 Dec 2024

Sponsor / Collaborator

The First Affiliated Hospital of Soochow University

NCT06616194 / RecruitingPhase 3

AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE

The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.
Rimegepant is a tablet that dissolves when you put it on or under your tongue.
The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours
In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.
Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.
In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.
Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.

Start Date15 Nov 2024

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Rimegepant Sulfate

100 Translational Medicine associated with Rimegepant Sulfate

100 Patents (Medical) associated with Rimegepant Sulfate

175

Literatures (Medical) associated with Rimegepant Sulfate

31 Dec 2024·Journal of medical economics

Cost-effectiveness of rimegepant oral lyophilisate compared to best supportive care for the acute treatment of migraine in the UK

Article

Author: Jenkins, Aaron ; Ahern, Aideen ; Powell, Lauren C. ; L’Italien, Gil J. ; Large, Sam ; Tran, Thang ; Popoff, Evan ; Johnston, Karissa ; Pawinski, Robert

AIMS:

Migraine is the most common disabling headache disorder and is characterized by recurrent throbbing head pain and symptoms of photophobia, phonophobia, nausea, and vomiting. Rimegepant 75 mg, an oral lyophilisate calcitonin gene-related peptide antagonist, is the first treatment approved for both the acute and preventative treatment of migraine, and the first acute therapy approved in over 20-years. The objective was to assess the cost-utility of rimegepant compared with best supportive care (BSC) in the UK, for the acute treatment of migraine in the adults with inadequate symptom relief after taking at least 2 triptans, or for whom triptans are contraindicated or not tolerated.

MATERIALS AND METHODS:

A de novo model was developed to estimate incremental costs and quality-adjusted life years (QALYs), structured as a decision tree followed by Markov model. Patients received rimegepant or BSC for a migraine attack and were assessed for response (pain relief at 2-h). Responders and non-responders followed different pain trajectories over 48-h cycles. Non-responders discontinued treatment while responders continued treatment for subsequent attacks, with a proportion discontinuing over time. Data sources included a post-hoc pooled analysis of the phase 3 acute rimegepant trials (NCT03235479, NCT03237845, NCT03461757), and a long-term safety study (NCT03266588). The analysis was conducted from the perspective of the UK National Health Service and Personal Social Services over a 20-year time horizon.

RESULTS:

Rimegepant resulted in an incremental cost-utility ratio (ICUR) of £10,309 per QALY gained vs BSC, which is cost-effectiveness at a willingness to pay threshold of £30,000/QALY. Rimegepant generated +0.44 incremental QALYs and higher incremental lifetime costs (£4,492). Improved QALYs for rimegepant were a result of less time spent with severe and moderate headache pain.

CONCLUSION:

This study highlights the economic value of rimegepant which was found to be cost-effective for the acute treatment of migraine in adults unsuitable for triptans.

01 Dec 2024·CNS & Neurological Disorders-Drug Targets

Safety and Efficacy of Calcitonin Gene-related Peptide Receptor Antagonists and Selective Serotonin Receptor Agonist in the Management of Migraine: A Systematic Review and Meta-analysis

Review

Author: Datusalia, Ashok Kumar ; Singh, Pooja ; Kumar, Anoop ; Ponnada, Rakesh Kumar ; Sharma, Ruchika ; Sumadhura, Bommaraju

Background::

Recently, US Food and Drug Administration (FDA) has approved calcitonin gene-related peptide receptor antagonists (rimegepant, and ubrogepant), and selective serotonin receptor agonists (lasmiditan) in the management of migraine. However, the exact safety and efficacy profile of these drugs is unclear so far.

Methods::

The study’s primary objective was to determine the exact safety and efficacy profile. The overall estimate was calculated in terms of risk ratios using a suitable model. The subgroup analysis was also performed to check the effect of individual drugs on the outcome, whereas sensitivity analysis was performed to check the effects of outliers on the outcome. All the analyses were performed using Rev Man 5. The drugs have shown significant improvement in efficacy parameters (pain freedom, most bothersome symptoms, phonophobia, nausea, and photophobia).

Results::

The subgroup analysis results have shown significant improvement in all efficacy parameters in the rimegepant and ubrogepant groups. The effect of ubrogepant on safety parameters was found to be non-significant, indicating a better safety profile of ubrogepant than lasmiditan.

Conclusion::

The sensitivity analysis results have shown no effect of outliers on the efficacy parameters. Based on the available evidence, recently approved drugs are effective in the treatment of migraine, however, associated with few adverse drug reactions.

01 Dec 2024·REVUE NEUROLOGIQUE

Migraine treatment: Position paper of the French Headache Society

Review

Author: Roos, C ; Moreau, N ; Lucas, C ; Mawet, J ; Grangeon, L ; Demarquay, G ; Donnet, A ; de Gaalon, S ; Valade, D ; Moisset, X ; Giraud, P ; Ducros, A ; Gollion, C ; Lantéri-Minet, M ; Corand, V ; Guégan-Massardier, E

The French migraine management recommendations were published in 2021. However, in the last three years, new data have come to light and new drugs have been approved (eptinezumab, rimegepant and atogepant) by the European Medicines Agency that require us to take a position on their use and to update certain elements of the recommendations. The first important message concerns the position of the French Headache Society on the use of preventive treatments (monoclonal antibodies and gepants) targeting the calcitonin gene-related peptide (CGRP) pathway. In terms of efficacy and safety, and as suggested by other national headache societies, these treatments can be offered as first-line treatment, although the scope defined by the French national health authority for possible reimbursement is limited to patients with severe migraine, at least eight headache days per month and for whom two previous preventive treatments have failed. Another important change concerns the position of topiramate as a preventive treatment for migraine in women of childbearing age. This treatment has been proposed as a first-line treatment for chronic migraine. However, recent pharmacovigilance data have highlighted a potential adverse effect on neurodevelopment in children exposed in utero. As a result, this treatment is formally contraindicated during pregnancy and must be used with extreme caution in women of childbearing age (effective contraception, no therapeutic alternative available and annual follow-up as with valproate). It can therefore no longer be offered as first-line treatment for women of childbearing age.

News (Medical) associated with Rimegepant Sulfate

30 Oct 2024

·www.pharmaceutical-technology.com

Pfizer boasts over 30% increase in Q3 revenues against previous year

Pfizer CEO Dr Albert Bourla presided over an exceptional Q3 amid financial decline and pressure from investor Starboard Value. Credit: Ververidis Vasilis / Shutterstock. Pfizer has reported strong revenues in its latest earnings report, noting increased revenues over Q3 2023 largely due to sales from the company’s Covid-19 drugs Paxlovid and Comirnaty. In the 29 October report, Pfizer stated overall revenues in Q3 2024 had risen by 31% compared to the same quarter in the previous year, amounting to an additional $4.3bn. Of the total $17.7bn in Q3 revenues, $2.7bn and $1.4bn were derived from sales of Paxlovid and Comirnaty, respectively, which together accounted for almost half of the company’s year-over-year growth. The robust Q3 report did little to affect share price, although traded share volume rose to a level unseen since the company acquired Seagen in December 2023. Pfizer’s market cap is currently $161bn. This month has also seen disruption to the company’s management, as activist hedge fund Starboard Value took a $1bn stake in Pfizer, equivalent to 0.6% of the company at the time of purchase. Aiming to steer a turnaround in Pfizer’s fortunes, Starboard accused company executives of “ coercive conduct ” against former CEO Ian Read and former CFO Frank D’Amelio who retracted support after initially supporting the fund’s plans. In the Q3 conference call, Pfizer CEO Albert Bourla stated: “While we agree with some of the points [Starboard] raised, we have vastly different views on many others.” See Also: How a patient helped shape a treatment for rare skin disorder ARIA-E risk of Lilly’s Kisunla in Alzheimer’s reduced with modified dosing He noted common dissatisfaction with shareholder return, but disagreed with Starboard’s challenge of Pfizer’s capital deployment, saying the company’s deals with Seagen and BioNTech “have been transformational for Pfizer”. Nonetheless, Bourla said some changes have been made at Pfizer this year to address Starboard’s such as separating US and international business and restructuring company management. The 31% Q3 growth over Q3 2023 was in sharp contrast to the overall growth of 2% for the first nine months of 2024 compared to those of 2023. Consequently, Pfizer has adjusted its financial guidance, raising projected revenues for 2024 to between $61bn and $64bn, up $1.5bn from estimates made in the company’s Q2 statement. This includes estimated sales of $5bn and $5.5bn from Comirnaty and Paxlovid, respectively, bringing the full year’s expected growth to 9% to 11% over 2023. Pfizer also attributed upticks in 2024 Q3 revenue to $854m in quarterly sales due to its acquisition of Seagen. Alongside this were increased operational revenues of 9% for Eliquis (apixaban), 28% for Xtandi (enzalutamide), 45% for Vydura (rimegepant sulfate), and 63% for Pfizer’s Vyndagel family (tafamidis) against equivalent quarterly revenues the previous year. Some drug-specific revenues did see decreases. Namely, revenues for Xeljanz (tofacitinib citrate) were down 35% and decreased by 12% for Ibrance (palbociclib) compared to Q3 2023. Drops in sales were attributed to label changes, lowered US net price, and expiry of exclusivity in Canada for Xeljanz, as well as competitive pressure and international price decreases for Ibrance. Bourla and Pfizer CFO David Denton gave statements attributing the company’s strong Q3 in part to ongoing cost reduction efforts and heightened demand for Paxlovid during the recent wave of Covid-19.

AcquisitionFinancial StatementIPO

19 Sep 2024

·www.fiercepharma.com

New migraine drugs less effective than previous generation of triptan meds: BMJ study

A meta-analysis of 137 trials of migraine drugs indicates that the newest class of treatments are less effective than the previous generation of triptan drugs in relieving acute headaches. A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.What's more, the newer drugs are no more effective in treating migraines than traditional headache remedies such as Tylenol, ibubrofen and aspirin, according to The BMJ's analysis.The study, a meta-analysis of 137 trials that together enrolled nearly 90,000 patients, indicates that the most effective treatments for migraine come from the triptan class. In head-to-head comparisons of the 17 drugs covered in the study, triptans demonstrated the best efficacy within 2 hours of use, led by eletriptan, which also delivered the best-sustained relief over 24 and 48 hours, according to the analysis.Eletriptan was brought to the market by Pfizer in 2002 and sold under the brand name Relpax. The next most effective medicines in providing relief at 2 hours were the following triptans (in order of performance): rizatriptan, sumatriptan and zolmitriptan. Rizatriptan is sold by Organon as Maxalt. GSK sells sumatriptan as Imitrex and AstraZeneca markets zolmitriptan as Zomig.“Triptans are currently widely underused, and access to the most effective triptans should be promoted globally and international guidelines updated accordingly,” the authors wrote. The BMJ analysis also concluded that the newest class of migraine treatments—which are called calcitonin gene-related peptide receptor (CGRP) antagonists—should only be used after traditional headache meds.“While the recent introduction of lasmiditan (Reyvow), rimegepant (Nurtec), and ubrogepant (Ubrelvy) has expanded options for the acute treatment of migraine, the high cost of these newer drugs, along with the substantial adverse effects of lasmiditan, suggest their use as third-line options, after the less expensive, similarly efficacious, second-line options," the authors wrote.While the BMJ study focused on acute treatment of migraines, new CGRP treatments have also been approved as preventatives. Nurtec pills, for example, were approved in 2021 for use every other day to ward off potential migraines. Much hope has been pinned on the effectiveness of CGRP drugs. In 2022, Pfizer spent $11.6 billion in a buyout of Biohaven to gain Nurtec, which rolled up sales of $928 million last year. Meanwhile, Ubrelvy, which was approved in 2019, generated $815 million in sales.Several other CGRPs—all approved in 2018 for the prevention of migraines—also remain formidable. Eli Lilly’s Emgality generated $678 million in sales last year, while Teva’s Ajovy pulled in $435 million and Amgen’s Aimovig collected $303 million. Besides those drugs, Lundbeck's Vyepti won approval in 2020 and generated about $250 million last year.

Drug ApprovalAcquisitionClinical Result

13 Sep 2024

·www.fiercepharma.com

Tonix questions efficacy of oral migraine drugs in awareness campaign

Tonix is set to launch a disease education website to explain the link between gastroparesis and migraine. Tonix Pharmaceuticals is trying to start a conversation about a potential shortcoming of oral migraine drugs, kicking off a national campaign to raise awareness of a condition that can affect absorption.The company’s commercial subsidiary, Tonix Medicines, markets two formulations of sumatriptan for use in migraine. Sumatriptan was approved more than 30 years ago. Dr. Reddy’s Laboratories received FDA approval for an injectable formulation, Zembrace SymTouch, in 2016 and a nasal spray version in 2019. Tonix acquired the products in 2023.Facing off against oral drugs such as AbbVie’s Ubrelvy, Tonix is seeking to raise awareness of potential benefits of nasal and injectable formulations with the “Does Your Migraine Pill Work Every Time?” Tonix launched the campaign at the PAINWeek 2024 National Conference in Las Vegas.The question posed in the educational campaign reflects studies showing a link between gastroparesis and migraine. Gastroparesis is defined by the delayed emptying of the contents of the stomach into the intestine, potentially causing symptoms such as vomiting. Studies show some patients have migraine and gastroparesis at the same time. If that happens, gastroparesis could limit the absorption of oral drugs. “Non-oral migraine medications, such as injectables and nasal sprays, do not rely on the digestive system to be absorbed and can offer the potential for faster relief from migraine symptoms in as little as 10 minutes,” the University of Texas Southwestern Medical Center’s Deborah Friedman, M.D., said in a statement. Friedman encourages patients and doctors to discuss adding non-oral options to their treatment plans.Tonix is set to launch a disease education website to explain the link between gastroparesis and migraine and why oral medicines may not work. The company has also scheduled a webinar on the topic for next week.Spreading the word about situations in which oral drugs may be ineffective could benefit Tonix’s drugs, sales of which totaled $2.2 million in the second quarter. The figure makes Tonix a small player in the migraine market. Pfizer reported $356 million in sales of Nurtec ODT, which dissolves in the mouth, over the same period. AbbVie’s Ubrelvy and Qulipta generated a combined $381 million.

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.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Temporomandibular Joint Disorders	Phase 3	US	Pfizer Inc.	05 May 2022
Chronic rhinosinusitis with nasal polyps	Phase 3	US	Pfizer Inc.	17 Feb 2022
Nasal Polyps	Phase 3	US	Pfizer Inc.	17 Feb 2022
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	Pfizer Inc.	22 Oct 2020
Acute migraine	Phase 3	CN	Bioshin Ltd.	22 Oct 2020
Acute migraine	Phase 3	KR	Bioshin Ltd.	22 Oct 2020
Acute migraine	Phase 3	KR	Pfizer Inc.	22 Oct 2020

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03266588 (phase II/III safety study of rimegepant, Pubmed \| Pain Ther)	Phase 2/3	anxiety \| depression \| SSRIs ... View more	1,800	Rimegepant 75 mg	ruwatvtmws(zgrrmrnodm) = mnseeukyhl bwnvkrfppg (wbtbbmbwgx ) View more	Positive	09 Nov 2024
				Placebo	ruwatvtmws(zgrrmrnodm) = bvonzyonsy bwnvkrfppg (wbtbbmbwgx ) View more
NCT03266588 (Pubmed) Manual	Phase 2/3	Migraine Disorders	1,800	Rimegepant 75 mg	zhpwpltznh(wasinvldke) = ukhkbrxryi cpqzlpznkb (zqxgbmdlsy ) View more	Positive	10 Jul 2024
				Rimegepant (CV risk 1)	zhpwpltznh(wasinvldke) = oxlxarccvj cpqzlpznkb (zqxgbmdlsy ) View more
NCT03235479 (Pubmed) Manual	Phase 3	Migraine Disorders	1,162	Rimegepant 75 mg oral tablet	clzzedfdpc(tvsptltnle) = lyjhuoqebw exnxuvkoii (xhbkerfyfj ) View more	Positive	01 Jul 2024
				Placebo	clzzedfdpc(tvsptltnle) = moqtsohauy exnxuvkoii (xhbkerfyfj ) View more
NCT03941834 (BHV3000-202, CTgov)	Phase 2	Trigeminal Neuralgia	65	Rimegepant (DBT Phase: Pooled Rimegepant)	rixzgbaoqr(rifosnbjvk) = nojxygrzqm vvildcgwhv (bcsixhptul, jprvzlbdyb - zbnrxgtldq) View more	-	10 Jun 2024
				placebo+rimegepant (DBT Phase: Pooled Placebo)	rixzgbaoqr(rifosnbjvk) = cupweduyqa vvildcgwhv (bcsixhptul, darzytrcab - aoekvmhhrc) View more
NCT05262517 (CTgov)	Phase 3	Temporomandibular Joint Disorders	126	Rimegepant (BHV3000 (Rimegepant (BHV3000))	lrxtxnflfd(uvulyjmxhq) = drqtxhgrgg zvltblbbuv (donmwmseeb, zvtxmlhwju - irbsgvblkh) View more	-	16 May 2024
				placebo+rimegepant (Placebo)	lrxtxnflfd(uvulyjmxhq) = hiexqnbfxa zvltblbbuv (donmwmseeb, lfuxwujunh - jyhqxhdjks) View more
NCT04574362 (Pubmed) Manual	Phase 3	Acute migraine	1,075	Rimegepant ODT 75 mg	ywqpkhiufd(vozxdvbggo) = cdndlbqrcu zikvsxsort (zcwhazappm ) View more	Positive	16 Apr 2024
				Placebo	ywqpkhiufd(vozxdvbggo) = nkiawjperh zikvsxsort (zcwhazappm ) View more
AAN2024	Not Applicable	Migraine Disorders	-	Rimegepant	smhbbpntcg(zkaruxgdnv) = dzcqwtmzgj ybphxobtfb (pwfcvaimja, 56.0%–60.2%) View more	-	09 Apr 2024
				Zavegepant	smhbbpntcg(zkaruxgdnv) = nvlbwqohqz ybphxobtfb (pwfcvaimja, 56.4%–62.5%) View more
P7-12.010 (AAN2024)	Not Applicable	Migraine Disorders CGRP	10	Rimegepant	iksgktlqbi(zdfmxnsyar) = other had dyspepsia wlvcotxpbu (nyljqbrtol ) View more	Positive	09 Apr 2024
NCT03266588 (Pubmed \| Cephalalgia) Manual	Phase 2/3	Migraine Disorders calcitonin gene-related peptide receptor	1,800	Rimegepant 75 mg PRN 2-8	jynwmhtxyq(ggllymcvuy) = upper respiratory tract infection (8.8%), nasopharyngitis (6.8%) and sinusitis (5.1%). Most AEs were mild or moderate and considered unrelated to rimegepant. cslbozirab (mjughrkzaw ) View more	Positive	01 Apr 2024
				Rimegepant 75 mg PRN 9-14
NCT04574362 (BHV3000-310, CTgov)	Phase 3	Acute migraine	1,648	Placebo	cjlxjgfzgd(oremvjqrgc) = pnqtsnytor mmaqhiahiy (spppxpmvbn, yyxwykesfb - bscmgycunj) View more	-	14 Dec 2023

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