A Comparison of Rimegepant Orally Disintegrating Tablet (Nurtec ODT) to Rizatriptan Benzoate Orally Disintegrating Tablet (Maxalt MLT-ODT) in Adult Patients Presenting to the ED With Migraine Headache: Randomized, Double-Blind, Clinical Trial

Rimegepant (Nurtec) is an orally administered small molecule CGRP receptor antagonist with efficacy in the acute treatment of migraine. Rizatriptan benzoate (MAXALT), is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan binds with high affinity to human cloned 5-HT1B and 5-HT1D receptors which leads to activation of these receptors results in cranial vessel constriction, inhibition of neuropeptide release and reduced transmission in trigeminal pain pathways with resultant relieve of the headache.
Teh investigators hypothesize that the administration of Rimegepant ODT would provide better analgesic efficacy than Rizatriptan ODT with respect to analgesic efficacy at 60 min and 120 minutes in ED patients with acute headache.
This is a prospective, randomized, double-blind superiority trial evaluating and comparing analgesic efficacy and safety of Rimegepant ODT 75 mg to Rizatriptan ODT 10 mg in adult patients presenting to the Emergency Department of Maimonides Medical Center with acute migraine headache.

Start Date01 Sep 2024

Sponsor / Collaborator

Maimonides Medical Center

IRCT20230913059428N1

/ SuspendedPhase 3IIT

A clinical trial of sublingual Rizatriptan versus oral Betahistin in acute phase treatment of vertigo in patients suffering from vestibular migraine

Start Date23 Oct 2023

Sponsor / Collaborator

Tabriz University of Medical Sciences

NCT04384367

/ CompletedPhase 3

A Multicenter, Double-blind, Double-dummy, Randomized, Single-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine

A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Start Date30 Dec 2022

Sponsor / Collaborator

Eurofarma Laboratórios SA

100 Clinical Results associated with Rizatriptan Benzoate

100 Translational Medicine associated with Rizatriptan Benzoate

100 Patents (Medical) associated with Rizatriptan Benzoate

1,694

Literatures (Medical) associated with Rizatriptan Benzoate

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Lost earnings among triptan non-responders in the general population of Denmark: a measure of disproportionate migraine-attributed burden and of unrecognised and unmet treatment need

Article

Author: Spanggaard, Maria ; Steiner, Timothy J. ; Ashina, Messoud ; Hansen, Jakob Møller ; Hauberg, Daniel Sloth ; Stallknecht, Sandra Benkjer ; Lønberg, Ulla Sofie ; Hansen, Thomas Folkmann ; Olsen, Jens

AIMS:

Migraine leads to substantial healthcare utilization and associated costs. However, much higher costs are attributed to lost productivity. The impact of effective migraine treatment on these costs, at the individual level, has not been well established. Even less known is the impact of treatment failure. The objective of this study was to assess lost earnings as a measure of migraine-attributed burden among triptan non-responders in Denmark.

MATERIALS AND METHODS:

We used data from the Danish National Prescription Register and Danish Income Statistics Register over the 27-year period 1995-2021. We identified 4,979 triptan non-responders (85.9% female) and matched them for sex, age and region of residence with 14,292 continuing users of triptans (triptan responders) and 13,592 individuals from the background population (triptan never-users). We then estimated average annual individual earnings, and compared those among triptan non-responders, from 3 years prior to and 10 years after their last triptan redemption, with those among their matched triptan responders and triptan never-users over the same periods.

RESULTS:

Triptan non-responders earned significantly less than both their matched triptan responders and their matched triptan never-users. The earnings gap was evident even 3 years prior to the last triptan prescription (€4,344 and €4,356 respectively). This gap widened substantially over time, so that average cumulative earnings over the 14-year period of follow-up for each triptan non-responder were €93,684 less than those of responders and €99,485 less than those of never-users.

LIMITATIONS:

There are uncertainties with regard to the reasons for triptan discontinuation (whether non-response or otherwise), and to lack of diagnostic confirmation of migraine.

CONCLUSIONS:

Triptan non-response represents failure of currently available acute treatment options. It is associated with substantial and cumulative lost earnings, highlighting a disproportionate economic burden. These findings underscore the potential economic benefit of recognizing, and rectifying, unmet treatment needs in migraine management.

04 May 2025·Expert Opinion On Drug Safety

Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database

Article

Author: Zhang, Hongrui ; Zhang, Shuohan ; Jiang, Cheng ; Wan, Xiaochen

BACKGROUND:

Lasmiditan offers a promising option for the treatment of migraines, particularly for individuals with cardiovascular concerns. It is crucial to gather comprehensive safety information of lasmiditan through large-scale post market monitoring.

RESEARCH DESIGN AND METHODS:

This study assessed the safety profile of lasmiditan based on real-world data of FDA Adverse Event Reporting System (FAERS) database. Four disproportionality analysis methods were applied to mining the significant signals. The differences in adverse event signals among different subgroups were investigated concerning race, sex, age, weight, dose, and concomitant drug.

RESULTS:

A total of 820 reports and 1,661 adverse events with lasmiditan as the primary suspected drug were identified. Two new adverse event signals related to nervous system disorders emerged. Females and males were more likely to develop paresthesia and dizziness, respectively. Most common adverse events were more likely to occur in the elderly patients and at high doses.

CONCLUSIONS:

It is essential to be vigilant about the relation of potential nervous system disorders with lasmiditan. The importance of heightened clinical vigilance regarding paresthesia in females and dizziness in males was underscored. Additionally, it is advised to administer a lower initial dose for elderly patients.

03 Apr 2025·Expert Review of Neurotherapeutics

The burden of migraine in Mexico: a database analysis of migraine-related visits to emergency departments in Mexico’s Ministry of Health (MMoH) hospitals

Article

Author: Osorio-Hernandez, Mariana ; Marfil, Alejandro ; Caballero, Nohemi ; Partida Medina, Luis Roberto ; Gudiño Castelazo, Manuel ; Pastrana, Martha Eugenia ; Sanchez Trujillo, Luis Arturo ; Julian, Guilherme Silva ; Galnares Olalde, Javier Andres

BACKGROUND:

The burden of migraine in Mexican Emergency Department (ED) settings remains understudied. This study aimed to determine the frequency of migraine-related ED visits within the ED Mexican Ministry of Health's (MMoH) database and analyze their demographics and treatment patterns.

RESEARCH DESIGN AND METHODS:

This retrospective study analyzed MMoH database of ED visits between 2013 and 2022. Visits with migraine diagnosis were selected using ICD-10 codes. Demographic characteristics, geographical location, and time of consultation were described, medication use patterns were analyzed.

RESULTS:

Between 2013 and 2022, there were 1,022,450 reported ED visits related to primary headache (0.6% of all ED visits), there were 179,618 migraine-related ED visits (19% of all headache visits). Females represented 78% of visits. Visits peaked in 2014 (20,066) and were the lowest in 2019 (8,273). Medication was used in 21% of visits, NSAIDs being the most frequent (15%). Triptan use was low (0.04% of all migraine visits).

CONCLUSION:

Our results highlight the significant burden of migraines on Mexico's healthcare system and the importance of considering age and sex in the approach to migraine ED visits. An update in therapeutic strategies for migraine in Mexico is needed to improve patient outcomes.

News (Medical) associated with Rizatriptan Benzoate

15 May 2025

·www.globenewswire.com

Amneal Receives U.S. FDA Approval for Brekiya® (dihydroergotamine mesylate) injection for the Acute Treatment of Migraine and Cluster Headaches in Adults

Brekiya® becomes the first and only DHE autoinjector that allows patients to self-administer the same medication used in hospitals in a ready-to-use form Product will be available for appropriate patients in the second half of 2025 BRIDGEWATER, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.1,2 Brekiya autoinjector provides patients with the potential for sustained* pain relief† in a convenient, self-administered form.1,3,4 It contains the same medication (DHE) used in hospitals, now in a ready-to-use device.1,5 Brekiya autoinjector does not require refrigeration, assembly, or priming of the device.1 Patients can deliver one dose subcutaneously into the middle of the thigh.1 This may be beneficial for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the attack.1,5,6 “We are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches. Physicians are familiar with DHE, which is an effective and well-established therapy that provides sustained relief for headaches. Our single-dose autoinjector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. DHE can be used at any point during a migraine attack, and may protect patients from headache recurrence.1,3,4 Approximately 39 million Americans are living with migraine7, and up to one million with cluster headache.8 Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all emergency room visits in the United States.9 There are limited treatment options available for cluster headache, and Brekiya autoinjector represents a new treatment option for this underserved population.2 Do not take Brekiya autoinjector with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below. IndicationBrekiya autoinjector is a prescription medicine used for the acute treatment of migraine with or without aura and acute cluster headaches in adults. Brekiya autoinjector is not used to prevent migraine or used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura). It is not known if Brekiya autoinjector is safe and effective in children. IMPORTANT SAFETY INFORMATIONSerious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Brekiya autoinjector) with strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together. Do not use Brekiya autoinjector if you: are taking medicines known as strong CYP3A4 inhibitors, such as: ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, ketoconazole, or itraconazole.have heart problems or a history of heart problems, or uncontrolled high blood pressure.have narrowing of blood vessels in your legs, arms, stomach, or kidneys (peripheral vascular disease).have sepsis, had vascular surgery, severe liver or kidney problems.are allergic to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in Brekiya autoinjector.have taken any of the following medicines in the last 24 hours: sumatriptan, frovatriptan, ergotamine or ergotamine-type medicines, almotriptan, naratriptan, zolmitriptan, eletriptan, or rizatriptanhave taken any medicines that constrict your blood vessels or raise your blood pressure. Before you take Brekiya autoinjector, tell your healthcare provider about all your medical conditions, including if you: have high blood pressure, liver problems, or kidney problems.have risk factors for heart disease, such as: high blood pressure, high cholesterol levels, smoke, are overweight, diabetes, family history of heart disease.are pregnant or plan to become pregnant. Brekiya autoinjector may cause preterm labor. Brekiya autoinjector should be avoided during pregnancy. Talk to your healthcare provider right away if you are pregnant or want to become pregnant.are breastfeeding or plan to breastfeed. Brekiya autoinjector may reduce breast milk supply and pass into your breast milk. Brekiya autoinjector may be harmful to your baby. Do not breastfeed your baby while taking Brekiya autoinjector and for 3 days after you use Brekiya autoinjector. Talk with your healthcare provider about the best way to feed your baby if you take Brekiya autoinjector. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: sumatriptan, ergot-type medicine, saquinavir, nefazodone, fluconazole, grapefruit juice, zileuton, nicotine, propranolol or other medicines that can lower your heart rate, any medicines that can increase your blood pressure, selective serotonin reuptake inhibitors. These are not all of the medicines that could affect how Brekiya autoinjector works. Your healthcare provider can tell you if it is safe to take Brekiya autoinjector with other medicines. How should I use Brekiya autoinjector? Certain people should take their first dose of Brekiya autoinjector in their healthcare provider’s office or in another medical setting.Brekiya autoinjector is for injection under the skin (subcutaneous) only.Use Brekiya autoinjector exactly as your healthcare provider tells you to use it.Each autoinjector contains one dose (1 mg).If your headache comes back after the first complete dose, you may give yourself up to 2 more doses as needed. Wait at least one hour between doses.Do not inject more than 3 doses (3 mg) of Brekiya autoinjector in a 24-hour period or 6 doses (6 mg) in a 1-week (7 day) period. What are the possible side effects of Brekiya autoinjector?Brekiya autoinjector can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking Brekiya autoinjector and get emergency medical help right away if you have any symptoms of a heart attack, such as: numbness or tingling in your fingers and toes, muscle pain or cramps in your arms and legs, weakness in your legs, temporary speeding or slowing of your heart rate, or swelling or itching. Brekiya autoinjector is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. Stroke. Stop using Brekiya autoinjector and get emergency medical help right away if you have any of the symptoms of a stroke.Changes in color or sensation in your fingers and toes (Raynaud’s syndrome).Stomach and intestinal problems.Increased blood pressure.Medicine overuse headache. Some people who use too much Brekiya autoinjector may make their headaches worse. If your headaches get worse, your healthcare provider may decide to stop your treatment with Brekiya autoinjector.Preterm labor.Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Brekiya autoinjector. Call your healthcare provider for medical advice about side effects. How should I store Brekiya autoinjector? Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze.Protect Brekiya autoinjector from light.Keep Brekiya autoinjector in the original pack until ready to use. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use at Brekiya.com. *Sustained represents a duration of approximately 24-72 hours2,3†Cluster headache results reported using IV administration.4 References: Brekiya [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.Data on File. Amneal Pharmaceuticals LLC.Winner P, Ricalde O, Le Force B, Saper J, Margul B. Arch Neurol. 1996;53(2):180-184.Mather PJ, Silberstein SD, Schulman EA, Hopkins MM. Headache. 1991;31(8):525-532.Silberstein SD, Shrewsbury SB, Hoekman J. Headache. 2020;60(1):40-57. doi:10.1111/head.13700Aurora SK, Papapetropoulos S, Kori SH, Kedar A, Abell TL. Cephalalgia. 2013;33(6):408-415.https://migraineresearchfoundation.org/about-migraine/migraine-facts/https://americanmigrainefoundation.org/resource-library/cluster-headache-2/Phelan, M, Thompson NR, Zubair A et al. Emergency department utilization among patients who receive outpatient specialty care for headache: A retrospective cohort study analysis. Headache. 2023;63:472–483. Brekiya is a registered trademark of Amneal Pharmaceuticals LLC. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Investor Contact Anthony DiMeoVP, Investor Relations anthony.dimeo@amneal.comMedia ContactBrandon SkopSr. Director, Corporate CommunicationsBrandon.skop@amneal.com PP-PRS-DHE-US-0001 05/2025

Drug Approval

13 May 2025

·www.prnewswire.com

Gensco Pharma® Acquires Global Rights and IP for RizaFilm® and RizaPort®

Company Plans Q4 2025 U.S. Launch and Global Expansion MIAMI, May 13, 2025 /PRNewswire/ -- Gensco Laboratories LLC d/b/a Gensco Pharma, (Gensco or the Company) a leader in specialty pharmaceuticals, proudly announces the acquisition of the global rights and intellectual property for the first and only rizatriptan Oral Dissolvable Film (ODF), which was co-developed under the trade names RizaFilm in the U.S. and both RizaFilm and RizaPort globally. Continue Reading Gensco Pharma® Acquires Global Rights & IP for RizaFilm® & RizaPort® - Plans Q4 2025 U.S. Launch and Global Expansion Post this RizaFilm® Packaging by Gensco® Pharma With this acquisition, Gensco Pharma is advancing its strategic initiatives by bringing innovative migraine treatment solutions to patients worldwide. RizaFilm is currently approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of migraine and associated nausea, photophobia and phonophobia. The EMA approval is from age 6 and upwards with the FDA approval from age 6-11 planned at launch. With the FDA and EMA approvals already secured, the Company is ramping up manufacturing and actively preparing for a U.S. launch of RizaFilm in Q4 2025. Concurrently, Gensco is working with existing and new licensing partners to expand market availability for RizaFilm and RizaPort internationally including China, India, the Middle East and the Americas. Gensco is strategically positioned to tap into the multi-billion-dollar migraine treatment market. The novel ODF technology of RizaFilm offers rapid administration not requiring water in a category dominated by tablets. This addresses unmet patient needs for convenience, portability, and faster relief. With global licensing discussions underway and a global supply chain, Gensco anticipates strong adoption by both patients and prescribers. Gensco's pricing strategy ensures RizaFilm will be affordable globally and makes treatment accessible to patients worldwide. "We are excited to bring RizaFilm to market under Gensco's leadership to deliver a consistent, high-quality and convenient treatment for patients in need," said Paul Zimmerman, MD, CEO of Gensco. "This acquisition solidifies our commitment to providing innovative solutions for migraine sufferers, and positions Gensco as a key player in the migraine treatment space." About RizaFilm and RizaPort RizaFilm and RizaPort utilize Gensco's proprietary oral dissolving film formulation of rizatriptan benzoate, designed for the acute treatment of migraines. This novel formulation offers an alternative to traditional tablets by eliminating the need for water, allowing for easier access, portability, administration, and faster relief. RizaFilm is particularly beneficial for patients experiencing migraine-associated nausea, photophobia, and phonophobia. The global migraine drugs market was valued at nearly $5.65 billion in 2023, and is projected to reach nearly $11 billion by 2030, with a compound annual growth rate of 15.6%. According to the American Migraine Foundation, approximately 42 million Americans suffer from migraines, making it the second leading cause of disability nationwide. According to an article published by the World Health Organization in March 2024, approximately 40% of the global population, equating to around 3.1 billion individuals, were affected by migraine and other headache disorders in 2021. About Gensco Gensco is a specialty pharmaceutical company focused on the development and commercialization of prescription and OTC products. The company leverages its expertise in innovative drug delivery systems to introduce products that improve patient outcomes. With a strong commitment to research and development, Gensco targets significant niche markets with high unmet medical needs. For more information, visit . Gensco Disclosure Notice: This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein, or which are otherwise made by or on behalf of Gensco that are not statements of historical facts may be deemed forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "enable", "believe," "anticipate," "intend," "could," "should," "would," "estimate," or "continue," or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. Readers are cautioned that all forward-looking statements involve risk and uncertainties which may cause results to differ materially from those set forth in the statements. Such risks and uncertainties include, but are not limited to the following: the success of research and development activities and the speed with which regulatory authorizations and product launches may be achieved; government regulation generally; the ability to successfully market products domestically and internationally; difficulties or delays in manufacturing or issues relating to manufacturing capacity; commercial obstacles to the successful introduction of brand products generally; and the risk of an adverse decision or settlement relating to product liability, patent protection, governmental investigations, and other legal proceedings; any changes in business, political and economic conditions; business interruption due to hurricanes or other relevant events outside of Gensco's control. For Gensco: Lissa Ajmo Gensco Pharma 8550 NW 33rd Street Miami, FL 33122 Phone : 855-7GENSCO (743-6726) Email : [email protected] SOURCE Gensco Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalAcquisitionLicense out/in

13 May 2025

·firstwordpharma.com

Axsome locks in $570M credit line as it gears up for migraine launch

Axsome Therapeutics has secured a $570-million term loan and revolving credit facility with Blackstone, giving the biotech a major line of credit ahead of the expected June rollout of its newly approved migraine drug Symbravo.The drug, which combines the 5-HT1B/1D agonist rizatriptan with COX-2 preferential non-steroidal anti-inflammatory drug meloxicam, was cleared by the FDA in January as an acute migraine treatment for adults, regardless of whether they experience aura. It later also succeeded in a Phase III trial involving patients who don't respond to oral CGRP inhibitors (see – Spotlight On: Axsome's Symbravo attacking gepants from all sides in migraine).However, while US doctors seem open to prescribing Symbravo, a recent FirstWord poll found that lack of awareness and unwillingness to switch from existing options could pose early hurdles for the drug's uptake (see – Physician Views Results: Axsome's Symbravo shows potential, but awareness and switching reluctance could pose headaches).Axsome said it gets better terms and more financial flexibility under the new loan agreement. Specifically, the new arrangement consists of a $500-million term loan facility and a $70-million revolving credit facility. In addition, Axsome can also access up to $250 million more at its discretion, plus another $200 million with Blackstone's approval. The company said it has already drawn $120 million to retire its previous term loan with Hercules Capital."The new agreement with Blackstone simultaneously expands our total available credit facility by more than $200 million, and significantly reduces our cost of capital," said CEO Herriot Tabuteau. Blackstone also purchased $15 million of Axsome's stock at the 30-day volume weighted average price of $107.14 per share.Meanwhile, Axsome is also advancing its depression candidate solriamfetol, already approved as Sunosi for narcolepsy. A recent Phase III trial fell short, but the company is hoping a positive signal in a subgroup will bear out in a larger Phase III trial of solriamfetol.

Phase 3Drug Approval

100 Deals associated with Rizatriptan Benzoate

External Link

KEGG	Wiki	ATC	Drug Bank
D00675	Rizatriptan Benzoate	N02CC04	DB00953

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Migraine Disorders	Mexico	Merck Sharp & Dohme Corp.	21 Jan 1998

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Migraine With Aura	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Apr 2007
Migraine Without Aura	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Apr 2007
Acute migraine	Phase 3	-	Organon & Co.	01 Mar 1995
Post-Traumatic Headache	Clinical	United States	Merck Sharp & Dohme Corp.	01 Feb 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FDA Manual	Not Applicable	Migraine Disorders	-	Rizatriptan 10 mg (Studies 1)	vwekniaact(quctlmzzcx) = lfsrlvmcmx lkywmjassh (hqzwchenok )	Positive	14 Apr 2023
				Placebo (Studies 1)	vwekniaact(quctlmzzcx) = iaxvesuius lkywmjassh (hqzwchenok )
NCT00360282 (Pubmed \| Cochrane Database Syst Rev)	Not Applicable	Migraine Disorders	133	Triptans	paulsuxmzh(kwgbcrxlwu): risk ratio = 0.84 (95% CI, 0.66 - 1.07)	-	12 Apr 2023
				Placebo
NCT02447991 (CTgov)	Phase 2/3	Vertigo \| Dizziness \| Migraine Disorders	223	Placebo (Placebo)	jqtftpnidg = hugemealpp ajvnvhidkq (uarqgltfvs, mlvlyourws - indljawayv) View more	-	04 Nov 2021
				Rizatriptan (Rizatriptan)	jqtftpnidg = kyvocvayyc ajvnvhidkq (uarqgltfvs, hjwerfxnpx - hoxcayfspq) View more
NCT01086358 (CTgov)	Phase 4	Migraine Disorders	60	almotriptan+eletriptan+Treximet+rizatriptan+sumatriptan+zolmitriptan+triptan (Arm 1 - Triptan)	eoymmbhgbf(uzylgiyvqb) = wctkdemcjv jiebnhiiyi (tvssvsxwyc, xsypfctdyr - ivuowzcfhh) View more	-	01 May 2018
				Naproxen Sodium (Treximet)+Sumatriptan (Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm)	eoymmbhgbf(uzylgiyvqb) = lnavkkstpk jiebnhiiyi (tvssvsxwyc, afnbdtoxmm - elepszjbqq) View more
NCT01004263 (Pubmed \| Headache)	Phase 3	Migraine Disorders	674	Rizatriptan 5mg	vdmsikderm(eudznhofzs) = sockdehrct zrmkixtalt (oxdukregpb ) View more	-	01 Jan 2013
				Rizatriptan 10mg	vdmsikderm(eudznhofzs) = icuoczrrzj zrmkixtalt (oxdukregpb ) View more
NCT01001234 (CTgov)	Phase 3	Acute migraine	1,382	Rizatriptan (Rizatriptan)	unghbcrhgx = vvmzkvajlj mqjajvlaqh (vzjpldsdqa, czugghsdah - zzxdhuuiun) View more	-	08 May 2012
				placebo (Placebo)	unghbcrhgx = zgunrqgxxd mqjajvlaqh (vzjpldsdqa, wgbmmiivdu - qvrzcweajt) View more
NCT01004263 (CTgov)	Phase 3	Migraine Disorders \| Acute migraine	674	rizatriptan benzoate	uhblrnuoxx = aboouavvza oxlimmwzvn (nuflnniwmq, dsonlyirfk - vzyrmqkoxp) View more	-	04 May 2012
NCT00604812 (Pubmed \| Headache)	Phase 1	Migraine Disorders	-	Rizatriptan ODT 5mg	uojsnyoiex(tavwhezrod) = yfzdvxahqv ctvwbtngax (brtbxqcdmo, 48.60 - 66.09) View more	-	01 Apr 2012
				Rizatriptan 10mg ODT	uojsnyoiex(tavwhezrod) = kolvwnmbyy ctvwbtngax (brtbxqcdmo, 68.93 - 89.38) View more
NCT00812006 (Pubmed \| Headache)	Phase 3	Acute migraine	108	Rizatriptan 10-mg ODT	ayexgprmkh(gspzvmryfa) = dpjirfltjl comdshiuri (dfyaxsyyjs ) View more	-	01 Jan 2012
				Placebo	ayexgprmkh(gspzvmryfa) = upjoqitjbs comdshiuri (dfyaxsyyjs ) View more
NCT01286207 (CTgov)	Phase 3	Migraine Disorders	1,959	Rizatriptan 5 mg (Rizatriptan 5 mg)	iuouvpjdtf(scwilwkdop) = uqyktqywrb qsmsinvovi (becjhxellc, bnuktuikzd - owmrqipuip) View more	-	10 Jun 2011
				Rizatriptan 10 mg (Rizatriptan 10 mg)	iuouvpjdtf(scwilwkdop) = nxmamfztqo qsmsinvovi (becjhxellc, sfmnxntjzm - hdpobhfirc) View more

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