A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.
Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico.
Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date23 May 2024

Sponsor / Collaborator

AbbVie, Inc.

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

NCT05654298 / CompletedNot ApplicableIIT

Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response After a Histamine Skin Prick as Well as After the Topical Application of Cinnamaldehyde and Capsaicin

The involvement of calcitonin gene-related peptide (CGRP) in the cinnamaldehyde-induced dermal blood flow increase and in the mechanism of action of triptans will be investigated. The capsaicin-induced dermal blood flow will be incorporated as a positive control; histamine skin pricks as a negative control. Changes in dermal blood flow will be measured with laser speckle contrast imaging.

Start Date15 Mar 2022

Sponsor / Collaborator

Katholieke Universiteit Leuven

100 Clinical Results associated with Ubrogepant

100 Translational Medicine associated with Ubrogepant

100 Patents (Medical) associated with Ubrogepant

124

Literatures (Medical) associated with Ubrogepant

01 Feb 2024·Neurology and therapy

Real-World Use of Ubrogepant as Acute Treatment for Migraine with an Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody: Results from COURAGE

Article

Author: Engstrom, Ella ; Lipton, Richard B ; Poh, Weijie ; Cadiou, François ; Contreras-De Lama, Janette ; Serrano, Daniel ; Manack Adams, Aubrey ; Ayasse, Nicolai D

INTRODUCTION:

Although acute and preventive treatments for migraine are commonly given in combination, data on the real-world effectiveness of ubrogepant as an acute treatment when used with an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (with or without onabotulinumtoxinA) are limited. This analysis sought to evaluate the real-world effectiveness, treatment satisfaction, and optimization of ubrogepant for the acute treatment of migraine when used in combination with an anti-CGRP monoclonal antibody, with or without concomitant onabotulinumtoxinA.

METHODS:

This prospective, multiple-attack, open-label, observational study (COURAGE) assessed meaningful pain relief (MPR), return to normal function (RNF), treatment satisfaction, and acute treatment optimization of ubrogepant (50 or 100 mg) when combined with an anti-CGRP monoclonal antibody, onabotulinumtoxinA, or both in adult users of Migraine Buddy, a migraine tracking application.

RESULTS:

In the ubrogepant and anti-CGRP monoclonal antibody arm (n = 245), following the first ubrogepant-treated attack, 61.6% (151/245) and 80.4% (197/245) of ubrogepant-treated participants achieved MPR at 2 and 4 h post-dose, respectively, and 34.7% (85/245) and 55.5% (136/245) achieved RNF at 2 and 4 h post-dose, respectively. Across up to 10 ubrogepant-treated attacks (N = 1153), MPR was achieved in 51.3% (592/1153) and 73.5% (847/1153) at 2 and 4 h post-dose, respectively. RNF was achieved by 32.2% (371/1153) and 53.2% (613/1153) at 2 and 4 h post-dose. After 30 days, 72.7% (168/231) of participants reported satisfaction (using a 7-point scale) with ubrogepant when used in combination with an anti-CGRP monoclonal antibody, and 79.7% (184/231) of participants achieved acute treatment optimization (defined as moderate-maximum treatment efficacy using the Migraine Treatment Optimization Questionnaire-4).

CONCLUSION:

Real-world ubrogepant use with an anti-CGRP monoclonal antibody was associated with MPR, RNF, satisfaction, and acute treatment optimization.

01 Jan 2024·Clinical and translational science

Ubrogepant: Mechanism of action, clinical and translational science

Article

Author: Trugman, Joel ; Boinpally, Ramesh ; Shebley, Mohamad

Abstract:

In recent years, the treatment of migraine has experienced a breakthrough in the development of drugs that target the calcitonin gene‐related peptide (CGRP) signaling pathway. Monoclonal antibodies against the receptor or ligand have been developed for the preventive treatment of migraine; whereas, orally administered small molecule CGRP receptor antagonists, called gepants, have been developed for both acute and/or preventive treatment. Both modalities have demonstrated safe and effective treatment of migraine, reducing the number of migraine days for patients as well as reducing symptoms and improving patient function and overall quality of life. 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.

01 Jan 2024·Revista de neurologia

Review

Author: Quintas, S ; Irimia, P ; Mínguez-Olaondo, A ; Layos-Romero, A ; Díaz-Insa, S ; 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 Ubrogepant

08 May 2024

·www.biospace.com

QULIPTA™ (atogepant) Now Approved by Health Canada for the Preventive Treatment of Chronic Migraine in Adults

QULIPTA is now the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved to prevent migraine across all frequencies, including episodic and chronic. Expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities. Approval was based on a pivotal Phase 3 clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days. AbbVie is the only pharmaceutical company to offer three treatments across the full spectrum of migraine to help patients living with this debilitating disease. MONTRÉAL, May 8, 2024 /CNW/ - AbbVie (NYSE: ABBV) announced today that Health Canada has approved QULIPTA (atogepant) for the prevention of migraine in adults who have at least four migraine days per month.1 QULIPTA is the first and only oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved to prevent both episodic and chronic migraine. "QULIPTA has been helping thousands of Canadians living with episodic migraine since December 2022. Now, QULIPTA offers a new option for those with the most challenging-to-treat chronic migraine," says Rami Fayed, Vice President and General Manager, AbbVie Canada. "With this approval, AbbVie is the only pharmaceutical company with three treatments across the entire migraine spectrum, including QULIPTA as a preventive treatment for both episodic and chronic migraine, BOTOX® (onabotulinumtoxinA) our foundational preventive treatment for chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for migraine attacks." QULIPTA's expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction of -6.9 from baseline in mean monthly migraine days compared to placebo of -5.1 across the 12-week treatment period.2 The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19.2. "Chronic migraine is incredibly debilitating for my patients. It makes day-to-day activities often unbearable, and isolates you from friends, family, and work," says Dr Ian Finkelstein, Medical Director of the Toronto Headache & Pain Clinic. "I have observed QULIPTA's ability to alleviate the challenges posed by episodic migraine in many of my patients, resulting in improved functionality, impressive response rates, and sustained efficacy. I'm excited to see Health Canada's approval of QULIPTA for chronic migraine and to be able to offer another treatment option to patients to help them successfully prevent their migraines." QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine. The overall safety pro QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including nausea, constipation, diarrhoea, and fatigue.1 "Bringing new migraine-specific medications to Canadians living with migraine is critical as so many have yet to find the relief they seek," says Wendy Gerhart, Executive Director of Migraine Canada. "Chronic migraine is a constant struggle for too many. We are pleased to see the approval of QULIPTA for this indication providing another safe and effective option and are confident it will have a positive impact on our community." About Migraine Migraine is a complex neurological disease with recurrent attacks that lasts 4-72 hours. It can be defined by symptoms such as moderate to severe pain intensity, nausea, vomiting, photophobia and phonophobia.3 An estimated 2.7 million Canadians are reported diagnosed with migraine, however the number of people living with migraine is much higher.4 Episodic migraine is characterized as having less than 15 headache days per month, while 15 headache days or more per month, is considered chronic.5 About QULIPTA (atogepant) QULIPTA (atogepant) is the first and only oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of episodic and chronic migraine. QULIPTA is an orally administered, small-molecule, selective calcitonin gene-related peptide (CGRP) receptor antagonist that blocks the binding of the CGRP to its receptor. CGRP is a neuropeptide that may play a role in migraine pathophysiology.1 For important safety information, please consult the QULIPTA Product Monograph. About AbbVie in Neuroscience At AbbVie, our commitment to people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow AbbVie Canada on X, Instagram, or LinkedIn. For more information on AbbVie's complete migraine portfolio, please visit SOURCE AbbVie Canada Company Codes: NYSE:ABBV

Phase 3Drug ApprovalClinical Result

26 Apr 2024

·firstwordpharma.com

AbbVie hikes full-year outlook as Skyrizi, Rinvoq offset Humira slump

AbbVie's first-quarter results presentation Friday revealed that newer anti-inflammatory treatments like Rinvoq and Skyrizi helped mitigate a 36% drop in Humira sales following the entry of biosimilar competition last year. Humira brought in $2.3 billion in the first three months of 2024, which was in line with analyst expectations, but well below the $3.5 billion it generated a year ago."First-quarter results were well ahead of our expectations, driven by excellent performance from our ex-Humira growth platform," stated chief operating officer Robert Michael, who is due to replace long-time CEO Richard Gonzalez in July.Other products in the company's immunology portfolio did the heavy lifting. Skyrizi posted sales of $2 billion, up 48% from the prior year, while Rinvoq contributed $1.1 billion, a 59% increase. The performances helped drive AbbVie's overall revenue to $12.3 billion, up nearly 1% from the same time last year, and exceeding consensus estimates of $11.9 billion.Holding on to Humira marketNine Humira biosimilars have been launched in the US since last year, although AbbVie still clings to a formidable 98% share of the drug's market (see – Physician Views Results: Lack of financial incentive and prescriber confidence stalling adoption of biosimilar Humira products). Earlier this month, Boehringer Ingelheim confirmed plans to let go some sales staff amid lower-than-expected uptake of its Humira biosimilar in the US.Bucking the trend is Sandoz's Hyrimoz, which unlike other Humira biosimilars, has seen a recent "explosion" in new prescriptions, according to an analyst note from Evercore ISI. The shift follows a decision by CVS Caremark, one of the largest pharmacy benefit managers in the US, to drop Humira from its major national commercial formularies earlier this year."As we round out the first year with biosimilar competition to Humira, we believe the company has managed the erosion well," remarked William Blair analyst Tim Lugo.'Firing on all cylinders'In other first-quarter results, AbbVie said blood cancer treatment Imbruvica generated $838 million in the quarter, a gain of 4.5% year-over-year, beating estimates of $744 million. Some investors have been worried about the possibility of mandated price cuts for the drug starting in 2026 after it was selected as one of 10 products subject to pricing talks with Medicare.Revenues from the company's neuroscience portfolio are also up, including the atypical antipsychotic Vraylar (+24% to $694 million), and the migraine treatments Ubrelvy (+34% to $203 million) and Qulipta (+98% to $131 million).AbbVie now expects adjusted profit of between $11.13 and $11.33 per share for this year, compared with $10.97 to $11.17 estimated previously.Commenting on the Q1 results, Lugo said AbbVie is "firing on all cylinders," with the performance "mainly driven by strength across the portfolio, particularly in the immunology franchise."

Financial StatementBiosimilar

20 Mar 2024

·www.prnewswire.com

Deerfield Agency Welcomes Bill Veltre as EVP, Head of Media

CONSHOHOCKEN, Pa., March 20, 2024 /PRNewswire/ -- Deerfield Agency, one of the leading health marketing and communications firms for health companies, today announced Bill Veltre has joined as Executive Vice President, Head of Media. With nearly two decades of experience in healthcare marketing, Bill will direct paid media services for the agency, guiding further development of the company's strategic and analytical approach to media and digital strategy. "Bill's appointment signifies an exciting milestone for Deerfield Agency as our media service offerings grow and we continue to enhance our media insights and reporting capabilities," said Frank Burrell, Managing Partner at Deerfield. "Recognized as a dedicated media-enthusiast and provocative thought leader, Bill will explore new opportunities in digital marketing and reporting, helping our clients drive meaningful engagement with patients and health care professionals." Bill is a seasoned healthcare marketing professional with expertise in the successful integration of media, creative, and analytics. He has held key roles at Elsevier, Digitas Health, WPP (CMI), Publicis (PHM), AbbVie (formerly Allergan), and most recently served as Senior Director of Omnichannel Strategy at Bristol Myers Squibb. With a focus on both patient impact and business success, some of his most notable achievements include leading successful patient marketing initiatives for QULIPTA at AbbVie and paid promotions for the UBRELVY launch in the migraine category. "I am thrilled to join the Deerfield team and play a key role in driving the agency's continued success," said Veltre. "Critical to pharmaceutical marketing today is how to effectively engage with HCPs and patients and how we leverage insights to improve the effectiveness of marketing efforts. Deerfield has built a true marketing engine powered by omnichannel approaches, data and analytics, and creative strategy. I'm looking forward to partnering with my new colleagues to continue to refine our approaches and help our clients deliver on the promise of their products." About Deerfield Agency Deerfield Agency, part of Deerfield Group, is a full-service, integrated marketing, advertising, and communications agency focused on crafting stories that matter and bridging meaningful connections to improve human health. With services spanning omnichannel marketing, creative, digital, media, print, public relations, and analytics, Deerfield is a true Agency of Brand®, purpose-built to scale with healthcare companies and brands, whether providing expert consultation, strategic execution, or serving as agency of record. Deerfield Agency services are rooted in the science of storytelling and powered by technology to ensure a focused strategy, optimized execution, and tangible outcomes. The company's team of industry leaders and specialists have deep experience working at every stage of a brand's life cycle to partner with executives and marketers to effectively market and deliver products to the patients who need them. Deerfield Agency is built to serve and designed to deliver. Learn more at DeerfieldAgency.com. Deerfield Group LLC Deerfield Group LLC is the parent company of Deerfield Agency and Verge Scientific Communications, a leading brand strategy and communications firm for emerging and pioneering health companies. Deerfield Group and its collective of partner firms blend marketing, advertising, and communications services to deliver focused solutions for companies advancing novel therapeutics and technologies. SOURCE Deerfield Agency

Executive Change

100 Deals associated with Ubrogepant

External Link

KEGG	Wiki	ATC	Drug Bank
D10673	Ubrogepant	N02C	DB15328

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	AbbVie, Inc.	23 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine Without Aura	Phase 3	US	AbbVie, Inc.	14 Jan 2022
Migraine Without Aura	Phase 3	PR	AbbVie, Inc.	14 Jan 2022
Acute migraine	Phase 2	-	Allergan Plc	01 Jul 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04492020 (PRODROME, Literature) Manual	Phase 3	Migraine Disorders	518	Ubrogepant	ksodgpkokn(xbqqavfoal) = rfqnkagumm yxjheynipl (ulaovebigx ) View more	Positive	15 Nov 2023
				placebo	ksodgpkokn(xbqqavfoal) = hrvqtimrye yxjheynipl (ulaovebigx ) View more
NCT04492020 (PRODROME, AAN2023)	Phase 3	Migraine Disorders calcitonin gene-related peptide (CGRP) receptor	-	Ubrogepant 100 mg	yydusedese(devlabypyw) = xtijrdkpor jwnpyufiva (rqkofcfsui ) View more	-	25 Apr 2023
				Placebo	yydusedese(devlabypyw) = klbtddhbec jwnpyufiva (rqkofcfsui ) View more
NCT02873221 (Pubmed)	Phase 3	Migraine Disorders	808	Ubrogepant-50mg	loqrdvblvz(tmmmwfqwkj) = mjewcjdlju iretzmlphg (lfhhfkxabs )	-	17 Aug 2022
				Ubrogepant-100mg	loqrdvblvz(tmmmwfqwkj) = gfvbvngfat iretzmlphg (lfhhfkxabs )
AAN2022	Phase 3	-	490	Ubrogepant 50mg	qhbhnacmnd(dhfyunmqso) = uafemirenx sqrhuqimun (kfyglaadko ) View more	-	03 May 2022
				Ubrogepant 100mg	qhbhnacmnd(dhfyunmqso) = bjywlgbtwy sqrhuqimun (kfyglaadko ) View more
UNIVERSE (AAN2022)	Not Applicable	-	302	Ubrogepant	ovhkvzsxzw(moxhskuwgl) = tvgqzwjgsx eayvpxkstz (xwbkepzovm ) View more	Positive	03 May 2022
NCT02873221 (AAN2022)	Phase 3	Headache	-	Ubrogepant 50 mg	kqdmtotdst(cysrbqmeyt) = wyxufxbnnx iivvxfknqo (ooslnwedpn ) View more	-	03 May 2022
				Ubrogepant 100 mg	kqdmtotdst(cysrbqmeyt) = qeqvnnigzz iivvxfknqo (ooslnwedpn ) View more
NCT02828020 \| NCT02867709 (ACHIEVE I and ACHIEVE II, Pubmed \| J Headache Pain)	Phase 3	Migraine Disorders	1,799	Ubrogepant	qcwquhwjdh(auzdrxrpfm) = umoctldmwj auxwnvbnpi (irtfqjiucg )	Positive	25 Apr 2022
				Placebo	qcwquhwjdh(auzdrxrpfm) = cmwmahfeuh auxwnvbnpi (irtfqjiucg )
AAN2021	Phase 3	-	1,938	Ubrogepant 50 mg	qenusgjzox(thzencdkqk) = 2% xxrjtasxrx (yjkdzqyyjl )	Positive	13 Apr 2021
				Placebo
ACHIEVE I and II (AAN2021)	Phase 3	Migraine Disorders	1,799	Ubrogepant 50 mg	sfmavahasz(ivszxdgwmp) = jxkocrlopj ngrhrrzial (ixvfputlic ) View more	Positive	13 Apr 2021
				Placebo	sfmavahasz(ivszxdgwmp) = zlimknjozh ngrhrrzial (ixvfputlic ) View more

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