Estetrol/drospirenone

Mithra and Searchlight Pharma Announce Nextstellis® Approval in Canada

Retrieved on: 
Monday, March 8, 2021
Organic compounds, Chemical compounds, Sex hormones, Hormonal contraception, Estranes, Estrogens, Phenols, Polyols, Estetrol, Drospirenone, DRSP, Estetrol/drospirenone

Developed by Mithra, Nextstellis is composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP) in a 24/4 dosing regimen.

Key Points: 
  • Developed by Mithra, Nextstellis is composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP) in a 24/4 dosing regimen.
  • "For this reason, the approval of an additional novel contraceptive option in Canada is incredibly welcome.
  • The approval in Canada is the first marketing authorization for Nextstellis in any jurisdiction, anywhere in the world.
  • "We are excited that Canada is the first market globally to approve Nextstellis, and that Searchlight Pharma can now move forward with its commercial launch and making this new contraceptive option available to Canadian women," said Mark Nawacki, President & CEO of Searchlight Pharma.

New Data Show NEXTSTELLIS® Has Selective Impact On Endocrine Markers Compared With Common Combined Oral Contraceptives

Retrieved on: 
Saturday, March 6, 2021
Steroids, Drugs, Sex hormones, Combined oral contraceptives, Estrogens, Hormonal contraception, Estranes, Phenols, Estetrol/drospirenone, Estetrol, Drospirenone, DRSP

"Based on our findings, treatment with DRSP/E4 has limited effects on some of these endocrine parameters compared to the tested EE-containing products, giving DRSP/E4 a different and potentially favorable endocrine profile compared to those EE-based COCs."

Key Points: 
  • "Based on our findings, treatment with DRSP/E4 has limited effects on some of these endocrine parameters compared to the tested EE-containing products, giving DRSP/E4 a different and potentially favorable endocrine profile compared to those EE-based COCs."
  • Comparative findings include:
    A significant increase in sex hormone-binding globulin (SHBG) was observed at cycle 3 (240%) and 6 (251%) with DRSP/EE as compared to baseline or those observed with NEXTSTELLIS (52% and 55%).
  • At cycle 6, NEXTSTELLIS had a significantly lower impact on dehydroepiandrosterone sulfate (DHEA-S) levels than DRSP/EE (10% vs. 27%).
  • Developed by Mayne Pharma's development and manufacturing partner Mithra Pharmaceuticals SA, NEXTSTELLIS is a novel, investigational combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 15 mg estetrol (E4).

Mayne Pharma launches another generic oral contraceptive

Retrieved on: 
Thursday, March 4, 2021
Combined oral contraceptives, Drugs, Health care, Ethinylestradiol/etonogestrel, Pharmacology, Combined oral contraceptive pill, Birth control pill formulations, Ortho, Estetrol/drospirenone, Generic drug, Ortho Pharmaceutical

This is the fourth oral contraceptive launched this calendar year after launching generic versions of LOESTRIN24 FE, ORTHO CYCLENand ORTHO TRI-CYCLEN.

Key Points: 
  • This is the fourth oral contraceptive launched this calendar year after launching generic versions of LOESTRIN24 FE, ORTHO CYCLENand ORTHO TRI-CYCLEN.
  • Mayne Pharma's CEO Scott Richards said, "We are very pleased to expand our Women's Health portfolio which now covers ~80% of Obstetrician/Gynaecologist oral contraceptive prescription volumes[1] and includes 24 marketed branded generic contraceptives.
  • Mayne Pharma is committed to helping meet the needs of women in the US by providing cost effective, high-quality and novel contraceptive options.
  • "In addition, Mayne Pharma has four women's health pipeline products pending at the FDA including the novel combined oral contraceptive NEXTSTELLIS (E4/DRSP) and a generic version of NUVARING.