X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development Clinical Trials

ABBVIE ANNOUNCES PLANS TO PROCEED TO PHASE 3 EVALUATION OF ELAGOLIX IN PATIENTS WITH UTERINE FIBROIDS

Yuvraj_pawp by Yuvraj_pawp
5th October 2015
in Clinical Trials

AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced the completion of a Phase 2b clinical trial evaluating the safety and efficacy of elagolix alone or in combination with add-back therapy compared to placebo. The trial was conducted in women with heavy menstrual bleeding (HMB) associated with uterine fibroids. Preliminary results showed that all of the elagolix treatment arms, with and without add-back therapy, reduced heavy menstrual bleeding as compared to placebo (p<0.001). The study’s primary endpoint was a composite design where subjects had to achieve a menstrual blood loss (MBL) volume of less than 80 mL as well as a 50 percent or greater reduction in MBL volume from baseline at the final study month as measured by the alkaline hematin method.

Uterine fibroids (also called leiomyomas or myomas) are noncancerous muscle tissue tumors of the uterus.1 Fibroids are most common in women aged 30-40 years but can occur at any age.1 They can range in size from nearly undetectable to bulky masses that can distort the uterus.2 Fibroids can be asymptomatic but in some women cause symptoms such as: longer, more frequent, or heavy menstrual bleeding; menstrual pain; vaginal bleeding at time other than menstruation; pain in the abdomen or lower back; pain during sex; difficulty urinating; frequent urination; constipation or rectal pain.

“The positive results from this trial represent an important milestone in the development of elagolix as a potential new treatment option for women suffering from heavy menstrual bleeding associated with uterine fibroids,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “Our clinical research with elagolix for the treatment of uterine fibroids complements ongoing Phase 3 endometriosis research. These two development programs demonstrate AbbVie’s continued commitment to therapeutic advances in women’s healthcare.”

Among the most common adverse events (AEs) were hot flush, headache, nausea, and vomiting. Some AEs such as hot flush were more frequent in the elagolix only treatment arms as compared to the placebo and elagolix with add-back therapy treatment arms. Reduction in bone mineral density associated with elagolix alone was attenuated when elagolix was co-administered with add-back therapy.

Discontinuations due to AEs were slightly greater for the elagolix 600 mg once-daily (QD) treatment arms with and without add-back therapy as compared to elagolix 300mg twice-daily (BID) treatment arms with and without add-back therapy.

 

The Phase 3 program is targeted to begin the first quarter of 2016 and will include two replicate, pivotal, six-month efficacy and safety studies followed by a six-month safety and efficacy extension study. The primary endpoint in Phase 3 studies will be the same as that employed in the Phase 2b study; percent of subjects with reduction in uterine blood flow as measured by the alkaline hematin method. Final results from this 2b trial will be presented at a medical conference in the future. Elagolix Uterine Fibroid Phase 2a data have been accepted for presentation at the 2015 Annual Meeting of the American Society of Reproductive Medicine in Baltimore, October 2015.

Trial Design

The Phase 2b trial (M12-813) is a 24-week, randomized, double-blind, multicenter, placebo-controlled, two cohort-design study that evaluates the safety and efficacy of two different elagolix treatment regimens (300 mg BID and 600 mg QD) alone and in combination with two different strengths of add-back therapy (estradiol/norethindrone acetate). It was conducted in approximately 567 premenopausal women, age 18 to 51, with HMB associated with uterine fibroids, at approximately 100 sites in the United States, Canada, Puerto Rico, Chile, and the United Kingdom.

About Elagolix

Elagolix is an oral agent currently being investigated for the inhibition of gonadatropin releasing hormone (GnRH) receptors in the pituitary gland which ultimately reduces circulating sex hormone levels.

To date, elagolix has been studied in over 40 clinical trials totaling more than 3,000 subjects. Phase 3 trials of elagolix for the management of endometriosis-associated pain are also ongoing.

Tags: Europe
Previous Post

Bayer aligns organization with Life Science businesses

Next Post

ABBVIE ANNOUNCES SUBMISSION OF A SUPPLEMENTAL NEW DRUG APPLICATION FOR IMBRUVICA® (IBRUTINIB) FOR TREATMENT-NAIVE CHRONIC LYMPHOCYTIC LEUKEMIA

Related Posts

Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer
Clinical Trials

Major Success Factors For Clinical Development Organizations

12th April 2022
ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East
Clinical Trials

ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

8th April 2022
Takara Bio and Boston IVF Fertility Center Announce Partnership to Enable the Derivation of Clinical-grade hES cell lines for Cell Therapy Applications
Clinical Trials

Calyx Selected by ProTrials as Partner for Improving Clinical Trial Outcomes Data

22nd March 2022
Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials
Clinical Trials

Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

7th February 2022
Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials
Clinical Trials

Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

7th February 2022
Qatar approves emergency use of Modernas COVID-19 vaccine
Clinical Trials

Moderna Starts Variant Specific Vaccine Trials After Pfizer

28th January 2022
Next Post

ABBVIE ANNOUNCES SUBMISSION OF A SUPPLEMENTAL NEW DRUG APPLICATION FOR IMBRUVICA® (IBRUTINIB) FOR TREATMENT-NAIVE CHRONIC LYMPHOCYTIC LEUKEMIA

Latest News

Global Biopharmaceutical Bioseparation Market Eyeing $20bn
Manufacturing

Global Biopharmaceutical Bioseparation Market Eyeing $20bn

4th July 2022
FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters
Manufacturing

FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters

4th July 2022
COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters
Manufacturing

COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters

4th July 2022
Fasenra shows consistent safety and sustained efficacy in long-term Phase III BORA trial in severe eosinophilic asthma
Manufacturing

AstraZeneca Cites Early Lung Cancer Immunotherapy Success

4th July 2022
FDA Experts Recommend Changing COVID Jab Formulation In Fall
Manufacturing

FDA Experts Recommend Changing COVID Jab Formulation In Fall

30th June 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In