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New Efficacy Data Reinforces NEXTSTELLIS® Benefits Across Patient Populations

New Efficacy Data Reinforces NEXTSTELLIS® Benefits Across Patient Populations Results presented at the 2021 American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting News provided by Share this article Share this article GREENVILLE, N.C., April 30, 2021 /PRNewswire/ Mayne Pharma announced today results from two studies showing treatment with NEXTSTELLIS® (3 mg drospirenone [DRSP] and 14.2 mg estetrol [E4] tablets) demonstrated contraceptive efficacy and excellent cycle control across subgroups, including age, body mass index (BMI)[1] and prior contraceptive use. NEXTSTELLIS is the first contraceptive pill containing E4, a new naturally occurring estrogen with a unique mechanism of action that offers potential advantages over other estrogens. The findings were presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting, held virtually in the U.S. from April 30 – May 2.

United statesMashonaland eastMayne pharmaPrnewswire mayne pharmaEstetrol drospirenoneKaren dombekMitchell creininUniversity of californiaMayne pharma groupAmerican college of obstetriciansWomen healthAnnual clinicalScientific meetingFamily planningPearl indexSubgroup analysis

U S FDA Approves NEXTSTELLIS®, New Oral Contraceptive

GREENVILLE, N.C., April 16, 2021 /PRNewswire/ Â Mayne Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved NEXTSTELLIS (3 mg drospirenone [DRSP] and 14.2 mg estetrol [E4] tablets) for the prevention of pregnancy. NEXTSTELLIS is the first and only contraceptive pill containing E4, a naturally occurring estrogen, now produced from a plant source, with a unique mechanism of action that offers potential advantages over other estrogens. When speaking with patients about their contraceptive options, one of the most common concerns is side effects, said Mitchell Creinin, Professor and Director of Family Planning at the University of California, Davis. NEXTSTELLIS is an innovative contraceptive that has been shown to be not only safe and effective, but also well tolerated in clinical trials with a desirable bleeding profile and minimal impact on triglycerides, cholesterol, and glucose, as well as weight and endocrine markers.

United statesMashonaland eastScott richardsMayne pharmaMitchell creininMithra pharmaceuticalsUniversity of californiaMayne pharma groupWomen healthDrug administrationFamily planningNative estrogenPrescribing informationSensitive malignancyFull prescribing informationMayne pharma group limited

U S FDA Approves NEXTSTELLIS®, New Oral Contraceptive

U S FDA Approves NEXTSTELLIS®, New Oral Contraceptive
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United statesMashonaland eastScott richardsMayne pharmaMitchell creininMithra pharmaceuticalsUniversity of californiaMayne pharma groupWomen healthDrug administrationFamily planningPrescribing informationSensitive malignancyFull prescribing informationMayne pharma group limitedLaura de zutter