O-136 Once-daily relugolix combination therapy results in sustained reduction in symptoms and improved quality of life in women with uterine fibroids treated over 52 weeks
AbstractStudy questionWhat is the effect of relugolix combination therapy (Relugolix-CT) on symptom burden and health-related quality-of-life (HR-QoL) in patients with uterine fibroids (UF) over 52 weeks?Summary answerRelugolix-CT demonstrated sustained, clinically meaningful improvement in patient-reported symptom severity and HR-QoL over 52 weeks in women with UF.What is known alreadyIn LIBERTY 1 and 2 randomized clinical trials, once-daily Relugolix-CT (40 mg relugolix, an oral gonadotropin-releasing hormone receptor antagonist, estradiol 1 mg, norethindrone acetate 0.5 mg) significantly reduced menstrual blood l...
Source: Human Reproduction - August 6, 2021 Category: Reproduction Medicine Source Type: research
O-135 Long term secondary efficacy of linzagolix for heavy menstrual bleeding (HMB) due to uterine fibroids (UF): 52-week results from two placebo-controlled, randomized, phase 3 trials
AbstractStudy questionAre symptomatic improvements in women with UF observed after 24 weeks of linzagolix treatment with or without add-back therapy (ABT) maintained over 52 weeks?Summary answerImprovements in anemia, pain and quality of life previously reported at 24 weeks were maintained at 52 weeks.What is known alreadyWe previously reported that partial or full suppression of estradiol (E2) with once daily doses of either 100 or 200 mg linzagolix for 24 weeks, with or without ABT, were effective in reducing heavy menstrual bleeding associated with uterine fibroids, improving other symptoms such as pain and anemia an...
Source: Human Reproduction - August 6, 2021 Category: Reproduction Medicine Source Type: research
O-132 Sustained efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT 52-week data
AbstractStudy questionTo assess the long-term (52-week) efficacy and safety of relugolix combination therapy (Relugolix-CT) in the treatment of endometriosis-associated pain.Summary answerRelugolix-CT demonstrated a sustained improvement of endometriosis-associated pain and maintenance of bone mineral density (BMD) over the extension treatment period. It was well tolerated.What is known alreadyEndometriosis is a chronic condition characterized by symptoms of menstrual and non-menstrual pain, and dyspareunia, which have a substantial impact on women ’s lives. SPIRIT 1 and 2 were Phase 3, randomized, double-blind, placebo-...
Source: Human Reproduction - August 6, 2021 Category: Reproduction Medicine Source Type: research
O-131 The effect of time since surgical diagnosis of endometriosis on treatment outcomes with relugolix combination therapy in women with endometriosis-associated pain: SPIRIT program
AbstractStudy questionTo assess the efficacy of Relugolix-CT vs placebo in women who were surgically diagnosed with endometriosis<5 and > = 5 years ago.Summary answerTreatment outcomes did not differ for dysmenorrhea and daily functioning between subgroups of patients with<5 years or ≥ 5 years since surgical diagnosis.What is known alreadyTime since clinical manifestation and diagnosis of endometriosis may influence the treatment success of patients with endometriosis-associated pain. SPIRIT 1 and 2 were randomized, double-blind, placebo-controlled Phase 3 studies of Relugolix-CT (relugolix 40 mg, ...
Source: Human Reproduction - August 6, 2021 Category: Reproduction Medicine Source Type: research
Relugolix, Estradiol, and Norethindrone Acetate
Am J Health Syst Pharm. 2021 Jul 21:zxab268. doi: 10.1093/ajhp/zxab268. Online ahead of print.NO ABSTRACTPMID:34286333 | DOI:10.1093/ajhp/zxab268 (Source: American Journal of Health-System Pharmacy : AJHP)
Source: American Journal of Health-System Pharmacy : AJHP - July 21, 2021 Category: Drugs & Pharmacology Source Type: research
Relugolix, Estradiol, and Norethindrone Acetate
Am J Health Syst Pharm. 2021 Jul 21:zxab268. doi: 10.1093/ajhp/zxab268. Online ahead of print.NO ABSTRACTPMID:34286333 | DOI:10.1093/ajhp/zxab268 (Source: American Journal of Health-System Pharmacy : AJHP)
Source: American Journal of Health-System Pharmacy : AJHP - July 21, 2021 Category: Drugs & Pharmacology Source Type: research
Myfembree for Fibroid-Associated Heavy Menstrual Bleeding
Date: August 9, 2021
Issue #:
1630Summary: Myfembree (Myovant/Pfizer), an oral fixed-dose
combination of the gonadotropin-releasing hormone
(GnRH) receptor antagonist relugolix, the estrogen
estradiol, and the progestin norethindrone acetate,
has been approved by the FDA for management of
heavy menstrual bleeding associated with uterine
leiomyomas (fibroids) in premenopausal women. It is
the second product to be approved in the US for this
indication;Oriahnn, which contains the GnRH receptor
antagonist elagolix in combination with estradiol and
norethindrone acetate, was approved earlier. R...
Source: The Medical Letter - June 29, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Effects of Lemborexant on the Pharmacokinetics of Oral Contraceptives: Results From a Phase 1 Drug ‐Drug Interaction Study in Healthy Females
AbstractLemborexant is a dual orexin receptor antagonist approved in multiple countries including the United States, Canada, and Japan for the treatment of insomnia in adults. As women of childbearing potential may be prescribed insomnia drugs, a drug-drug interaction study was conducted. This single-center, open-label, fixed-sequence study examined potential drug-drug interactions between lemborexant and an oral contraceptive (OC) in healthy females (18 –44 years, n = 20). The purpose of this study was to determine the effect of lemborexant 10 mg (at steady state) on the pharmacokinetics of a single dose of OC (0.03 mg ...
Source: Clinical Pharmacology in Drug Development - June 9, 2021 Category: Drugs & Pharmacology Authors: Ishani Landry,
Jagadeesh Aluri,
Nancy Hall,
Gleb Filippov,
Satish Dayal,
Margaret Moline,
Larisa Reyderman Tags: Original Manuscript Source Type: research
Oriahnn: New Drug Approved for Treating Heavy Menstrual Bleeding in Women With Uterine Fibroids
CONCLUSIONS: Elagolix plus add-back therapy is effective in reducing menstrual bleeding associated with uterine fibroids. However, there are several warnings and precautions that must be considered.PMID:33998300 | DOI:10.1177/10600280211015987 (Source: The Annals of Pharmacotherapy)
Source: The Annals of Pharmacotherapy - May 17, 2021 Category: Drugs & Pharmacology Authors: Sarah E Lynch Danielle C Mayer Source Type: research
Oriahnn: New Drug Approved for Treating Heavy Menstrual Bleeding in Women With Uterine Fibroids
CONCLUSIONS: Elagolix plus add-back therapy is effective in reducing menstrual bleeding associated with uterine fibroids. However, there are several warnings and precautions that must be considered.PMID:33998300 | DOI:10.1177/10600280211015987 (Source: The Annals of Pharmacotherapy)
Source: The Annals of Pharmacotherapy - May 17, 2021 Category: Drugs & Pharmacology Authors: Sarah E Lynch Danielle C Mayer Source Type: research
Oriahnn: New Drug Approved for Treating Heavy Menstrual Bleeding in Women With Uterine Fibroids
CONCLUSIONS: Elagolix plus add-back therapy is effective in reducing menstrual bleeding associated with uterine fibroids. However, there are several warnings and precautions that must be considered.PMID:33998300 | DOI:10.1177/10600280211015987 (Source: The Annals of Pharmacotherapy)
Source: The Annals of Pharmacotherapy - May 17, 2021 Category: Drugs & Pharmacology Authors: Sarah E Lynch Danielle C Mayer Source Type: research
Synthesis of [H ‐3]‐ and [C‐14]‐labeled elagolix
Gonadotropin ‐releasing hormone (GnRH) receptor antagonists are an important class of compounds designed to block the pituitary gland from synthesizing follicle‐stimulating hormone and luteinizing hormone for the treatment of sex hormone dependent disorders. Elagolix (ABT‐620) is currently approved for the treatment of pain associated with endometriosis and as a combination with estradiol and norethindrone acetate is approved for management of heavy menstrual bleeding due to uterine fibroids. In order to support the development of elagolix, we prepared [3H]elagolix for preclinical metabolism studies and [14C]elagolix...
Source: Journal of Labelled Compounds and Radiopharmaceuticals - March 23, 2021 Category: Biochemistry Authors: Eric D. Soli,
Bruce W. Surber,
Aimee D. Reed Tags: RESEARCH ARTICLE Source Type: research
Oriahnn for Fibroid-Associated Heavy Menstrual Bleeding
Date: April 5, 2021
Issue #:
1621Summary: Oriahnn (Abbvie), a fixed-dose combination of the
gonadotropin-releasing hormone (GnRH) receptor
antagonist elagolix, the estrogen estradiol, and the
progestin norethindrone acetate copackaged with
elagolix alone, has been approved by the FDA for oral
treatment of heavy menstrual bleeding associated
with uterine leiomyomas (fibroids) in premenopausal
women. It is the first product to be approved in the
US for this indication. Elagolix(Orilissa) has been
available since 2018 for treatment of moderate to
severe pain associated with endometriosis. The
...
Source: The Medical Letter - March 18, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
