FDA to Review Relugolix Combination Therapy for Uterine Fibroids
The NDA submission is supported by results from the phase 3 LIBERTY program.
Dysmenorrhea
Sustained Clinical Benefits Observed With Linzagolix in Uterine Fibroid Trials
Positive topline data were announced from two phase 3 studies evaluating the efficacy and safety of linzagolix (Yselty®; ObsEva) for the treatment of heavy menstrual bleeding due to uterine fibroids.
Clinically Meaningful Pain Reduction Observed With Relugolix in Endometriosis Trial
Positive topline results were announced from the phase 3 SPIRIT 1 study investigating relugolix (Myovant Sciences), in combination with estradiol and norethindrone acetate, in women with pain associated with endometriosis.
Oriahnn Approved for Heavy Menstrual Bleeding Due to Uterine Fibroids
The FDA has approved Oriahnn™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules; AbbVie) for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
FDA Approves OTC Combination of Ibuprofen and Acetaminophen
The FDA has approved Advil Dual Action with Acetaminophen (GlaxoSmithKline), the first over-the-counter (OTC) fixed-dose combination therapy containing ibuprofen and acetaminophen for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis. Each caplet contains 125mg of Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID)…
New Guidance Addresses Early Dx of Dysmenorrhea in Adolescents
Endometriosis is most common cause of secondary dysmenorrhea, looks different in teens than adults
Women Fed Soy Formula as Infants More Likely to Experience Menstrual Pain
Researchers at the National Institute of Environmental Health Sciences (NIEHS), Vanderbilt University Medical Center, and the Henry Ford Health System analyzed patient data from African-American women aged 23 to 35 years (N=1553) who were participating in the NIEHS Study of Environment, Lifestyle, and Fibroids (SELF).
Orilissa Approved for Moderate to Severe Pain Associated With Endometriosis
The approval was based on data from 2 multinational double-blind, placebo-controlled Phase 3 trials involving 1686 premenopausal women with moderate to severe pain associated with endometriosis.
Long-Term Efficacy Data Show Sustained Pelvic Pain Reduction With Elagolix
No new safety concerns were identified with elagolix use for the 12-month treatment period
Elagolix NDA Submitted for Treating Endometriosis-Associated Pain
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain.
