Breaking News
June 22, 2018 - Research does not confirm antidiabetic action of natural fatty acid derivatives
June 22, 2018 - Oxidative stress can be used against tumors to treat cancer
June 22, 2018 - Simple, cost-effective test may help improve early diagnosis of mild cognitive impairment
June 22, 2018 - New guide published to help battle fatal disease caused by kissing bugs
June 22, 2018 - Stigma Adds to Burden of Type 1 Diabetes
June 22, 2018 - In retinoblastoma survivors, oculo-visual issues tied to QoL
June 22, 2018 - Most adults with allergies do not use prescribed epinephrine even in emergency situations
June 22, 2018 - Study provides clues to how cancer cells develop resistance to chemotherapies
June 22, 2018 - New consensus paper serves as basis for uniform medical management of DSD
June 22, 2018 - Researchers work to identify areas of the brain that help us wake up
June 22, 2018 - Alcohol hangovers more significant and costly than people realize, shows research
June 22, 2018 - Targeting cells involved in blood vessel formation could hinder brain tumor growth
June 22, 2018 - Young cancer survivors need more support as they feel dissatisfied with their sexuality
June 22, 2018 - Unusual cell-to-cell communication in glioblastoma promotes aggressiveness and therapy resistance
June 22, 2018 - Turning A Phage – Drug Discovery Today
June 22, 2018 - World-first study links birth interventions and long-term childhood illness
June 22, 2018 - Improving the quality of biomedical research samples
June 22, 2018 - Researchers identify cerebral palsy using AI and DNA sequencing
June 22, 2018 - Administering nitric oxide gas after heart surgery may decrease risk of kidney problems
June 22, 2018 - Measuring levels of ethyl sulphate in hair can help assess alcohol consumption
June 22, 2018 - Researchers develop robot bloodhound that can rapidly detect odors on the ground
June 22, 2018 - AAA doses first patients in two clinical studies with PSMA-R2 for prostate cancer
June 22, 2018 - UC San Diego launches new bacteriophage therapy center
June 22, 2018 - New review outlines current state of sex-sensitive issues linked to heart failure drugs
June 22, 2018 - Pelvic pain a major issue for women nearing mid-life, research reveals
June 22, 2018 - Researchers develop reliable DNA barcodes for biomedical research
June 22, 2018 - New risk-prediction model may help identify diabetic patients at high risk of pancreatic cancer
June 22, 2018 - Study reveals how mTORC1-driven changes in crowding could influence major diseases
June 22, 2018 - Researchers uncover new therapeutic opportunity in the treatment of malignant melanoma
June 22, 2018 - UC Riverside researcher receives grants to advance cancer, ALS research
June 22, 2018 - Radiation therapy alone may be enough to treat older, sicker patients with anal cancers
June 22, 2018 - Technical report describes how to make accurate particle size measurements on carbon black samples
June 22, 2018 - Nocdurna (desmopressin acetate) Approved by FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria
June 22, 2018 - Neuroscientists locate neurons in the brain that respond when a visual target is found
June 22, 2018 - First human Keystone virus infection reported
June 22, 2018 - New study reveals how ‘good’ bacteria help in regulating our metabolism
June 22, 2018 - Osteopathic manual therapy affecting the diaphragm improves chronic low back pain
June 22, 2018 - Researchers create revolutionary model to study pulmonary diseases
June 22, 2018 - Diagnosing Heart Disease Using AI
June 22, 2018 - Increasing biodefense risks posed by synthetic biology
June 22, 2018 - Many Women Report Vasomotor Symptoms in Their 60s
June 22, 2018 - Rare mutation of gene carried by Quebec family gives insight into how the brain is wired
June 22, 2018 - Chemists find new way to make enzymes do a non-natural reaction
June 22, 2018 - Summer is good time to check for signs of skin cancer
June 22, 2018 - Innovative method can help identify patients with spastic cerebral palsy
June 22, 2018 - Exercise alters characteristics of blood to reduce inflammation in obese people
June 22, 2018 - Researchers examine complications across different types of breast reconstructive surgeries
June 22, 2018 - Rhesus macaque model could be useful to test therapies for congenital Zika virus syndrome
June 22, 2018 - AHA: New Insights Into Sickle Cell and Stroke Risk
June 22, 2018 - Doctors prescribe opioids at high rates to those at increased overdose risk
June 22, 2018 - Reduction in US cigarette smoking rates
June 22, 2018 - Preconception binge drinking may have negative effect on future offspring
June 22, 2018 - FDA expands approval of novel diabetes management device to include younger pediatric patients
June 22, 2018 - Researchers confirm weight loss benefits of the 16:8 diet
June 22, 2018 - FDA approves Eversense CGM system for use in adults with diabetes
June 22, 2018 - State opioid monitoring programs are not created equal
June 22, 2018 - Autistic teens who are bullied have higher rates of depression
June 22, 2018 - Penn Medicine team launches universal stroke awareness program
June 22, 2018 - Scientists discover the molecular trigger of necroptosis
June 22, 2018 - Researchers report unusually high levels of herpesvirus in the brains of people with Alzheimer’s disease
June 22, 2018 - Theoretical models predict how juveniles evolve to be more susceptible than adults to infection
June 22, 2018 - USC study reveals how the cell launches emergency response to repair damaged DNA
June 22, 2018 - $1.9 million grant aims to enhance behavioral health services in community-based settings
June 22, 2018 - New 3D imaging technique could improve arthritis treatment
June 22, 2018 - Cytokinetics Announces Data From Phase 2 Clinical Study of Reldesemtiv in Patients With Spinal Muscular Atrophy
June 22, 2018 - Polarized cells give the heart its fully developed form
June 21, 2018 - Stem cells appear to help fight obesity in animal models
June 21, 2018 - Harnessing Pediatric Cancer Genomic Data in the Cloud
June 21, 2018 - Training nursing students with cost-effective 3D-printed task trainers
June 21, 2018 - Study provides insight into how planned and spontaneous movements are processed in the brain
June 21, 2018 - Suicide Prevention | SAMHSA – Substance Abuse and Mental Health Services Administration
June 21, 2018 - From designer microbes to stem cells, researchers are investigating new strategies to treat bowel disease
June 21, 2018 - Study suggests state-of-the-art genomic testing for routine autopsy of stillbirths
June 21, 2018 - Christiana Care Health System opens first Epilepsy Monitoring Unit in Delaware
June 21, 2018 - CDC: Obesity Prevalence Higher in Non-Metropolitan Counties
June 21, 2018 - Youths Treated for Non-Suicidal Self Harm at Increased Risk of Suicide Within a Year
June 21, 2018 - WVU researchers increase colorectal cancer screening rates in West Virginia
June 21, 2018 - Pediatric kidney recipients often have subclinical inflammation
June 21, 2018 - OHSU Knight Cancer Institute Director wins 2018 Tang Prize in Biopharmaceutical Science
June 21, 2018 - Researchers study broader effects of neonics on wildlife
Allergan Announces Positive Top Line Phase 3 Results for Ubrogepant – an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

Allergan Announces Positive Top Line Phase 3 Results for Ubrogepant – an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

image_pdfDownload PDFimage_print

DUBLIN , Feb. 6, 2018 /PRNewswire/ — Allergan plc , (NYSE: AGN), a leading global pharmaceutical company today announced positive results from ACHIEVE I (UBR-MD-01), the first of two pivotal phase 3 clinical trials evaluating the efficacy, safety and tolerability of orally administered ubrogepant 50 mg and ubrogepant 100 mg compared to placebo in a single migraine attack in adults.

The ACHIEVE I study included 1327 U.S. adult patients (modified ITT population) randomized (1:1:1) to placebo, ubrogepant 50 mg and 100 mg respectively, who were treated for a single migraine attack of moderate to severe headache intensity. Both doses showed a statistically significant greater percentage of ubrogepant patients achieving pain freedom at 2 hours after the initial dose as compared to placebo patients (50 mg vs placebo, p=0.0023, 100 mg vs placebo, p=0.0003) and a statistically significant greater percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose as compared to placebo patients (50 mg vs placebo, p=0.0023, 100 mg vs placebo, p=0.0023).

“We are pleased with the favorable results of our ACHIEVE I study, which support the efficacy, safety, and tolerability profile of ubrogepant. We are confident that ubrogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist will be an option for the treatment of migraines in adults,” said David Nicholson , Chief Research and Development Officer, Allergan . ” Allergan remains committed to identifying, developing and bringing to market therapies that address unmet need for patients suffering from this debilitating disease.”

Ubrogepant was well tolerated with an adverse event profile similar to placebo. The most common adverse events were nausea, somnolence, and dry mouth, none of which were reported with a frequency of =5%. In terms of hepatic safety, across all treatment arms including placebo, there were 6 cases with aminotransferase (ALT or AST) elevations greater than 3 times the upper limit of normal (ULN); there were alternative explanations in all cases (concomitant illness or medication) and none were noted by the liver safety adjudication board to have a probable relationship to ubrogepant. There were no cases of Hy’s Law.

“Despite the prevalence of migraine and availability of several treatment options, the disease remains underdiagnosed and undertreated. There is also low persistence and adherence to the current standard of care treatments,” said lead investigator Dr. Richard B. Lipton , Vice Chair of Neurology, Professor of Epidemiology and Population Health and Director of the Montefiore Headache Center, all at the Albert Einstein College of Medicine . “There remains a need for new treatments with improved benefit-risk profiles. Results from this ubrogepant phase 3 trial are important in progressing the research and developing therapies to help migraine patients.”

Additional results from this study are anticipated to be released at upcoming scientific meetings throughout 2018.

Results of the second phase 3 trial, ACHIEVE II (UBR-MD-02), are expected in the 1st half of 2018. Allergan anticipates filing of a New Drug Application (NDA) to the FDA in 2019.

About ACHIEVE I (UBR-MD-01) Study

The ACHIEVE I trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 mg and 100 mg) compared to placebo for the treatment of a single migraine attack. The modified ITT population included 1327 adult patients 18-75 years of age with a history of migraine (with or without aura) were randomized (1:1:1) to placebo, ubrogepant 50 mg, or ubrogepant 100 mg and treated a single migraine attack of moderate or severe headache pain intensity at home. The co-primary efficacy parameters were pain freedom (PF) at 2 hours after the initial dose (defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose) and absence of the most bothersome migraine-associated symptom (photophobia, phonophobia or nausea) at 2 hours after the initial dose.

About Ubrogepant

Ubrogepant is a novel, highly potent, orally-administered CGRP receptor antagonist in development for the acute treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. CGRP receptor antagonism is a novel mechanism of action for the acute treatment of migraine that clearly differs from the mechanisms of currently available triptans (serotonin 1B/1D agonists) and opioids.

About Migraine

Migraine is a chronic disease with episodic attacks defined by neurological symptoms such as headache pain, sensitivity to light, sound, and nausea that are often incapacitating. It is highly prevalent, affecting approximately 1 in 7 individuals, and is associated with significant disability leading to societal and economic burden. The current standards of care in the acute treatment of migraine are not optimal for many patients’ due to partial effectiveness, poor tolerability, or contraindications. As a consequence, patients may experience repeated, uncontrolled attacks leading to medication overuse and increased risk of migraine disease progression. There is a need for new treatments for migraine with improved benefit-risk profiles as compared to current standard of care.

Allergan , a leader in the Chronic Migraine space, markets BOTOX® (onabotulinumtoxinA) the first and only FDA -approved, preventive treatment for adult Chronic Migraine patients since it was approved in 2010. Allergan is also advancing its migraine program with two investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists, which are being developed for the treatment and prevention of migraine. Allergan’s CGRP receptor antagonists, ubrogepant in Phase III for the acute treatment of migraine and atogepant in Phase IIB for the prevention of migraine, are expected to be the first oral CGRP receptor antagonists to market.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland , is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 55+ mid-to-late stage pipeline programs currently in development.

Allergan’s success is powered by our more than 18,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. For more information, visit Allergan’s website at www.Allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission , including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan’s Quarterly Report on Form 10-Q for the period ended September 30, 2017 . Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

SOURCE Allergan plc

Posted: February 2018

Tagged with:

About author

Related Articles