Levonorgestrel

Daré Bioscience’s DARE-LARC1 Platform Technology Achieves Proof-of-Concept Device that has Transformative Potential for Women’s Health as well as in Treating a Broad Range of Diseases

Retrieved on: 
Thursday, January 4, 2024
Levonorgestrel, LARC, Woman, IND, Software, FDA, Injection, Electronics, Diabetes, SAN, Fertility, DSM-IV codes, Osteoporosis, Obesity, Patient, Birth, Communication

This milestone reflects the drug delivery platform’s potential to address the treatment burden for various conditions where treatment requires frequent dosing or regular injections.

Key Points: 
  • This milestone reflects the drug delivery platform’s potential to address the treatment burden for various conditions where treatment requires frequent dosing or regular injections.
  • Daré is currently developing the platform technology internally with funding from a foundation grant in DARE-LARC1, a potential new class of long-acting, reversible contraceptive (LARC).
  • Key features of the implant technology include:
    Precision dosing: Unique design allows for precise dose timing and amount using individually addressable drug micro-reservoirs.
  • Smartphone integration: Platform can be paired with custom mobile apps designed for each application to create a personalized experience for the user.

Daré Bioscience Announces Grant Funding Installment to Support Further Development of Novel Contraceptive Technology DARE-LARC1

Retrieved on: 
Thursday, September 21, 2023
A Closer Look (Steve Harley & Cockney Rebel album), Human, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Human services, Office of Inspector General, U.S. Department of Health and Human Services, Birth, CRADA, Clinical trial, Levonorgestrel, MIT, NICHD, Bangladesh Technical Education Board, Trial of the century, Massachusetts Institute of Technology, Development, Bayer, Investigational New Drug, PMA, Cooperative research and development agreement, SAN, Menstrual cycle, Human development, Experience, Eunice Kennedy Shriver National Institute of Child Health and Human Development, FDA, Birth control, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Frederiksen, IND

Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1.

Key Points: 
  • Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1.
  • Daré received an initial $11.5 million payment in 2021 and aggregate payments of approximately $12.4 million in 2022 under the grant agreement.
  • “The DARE-LARC1 product candidate is one of a number of novel contraceptive technologies being developed by Daré,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • Bayer, in its sole discretion, has the right to make the license effective by paying $20.0 million to Daré.

Emergency contraception: here’s what you probably don’t know but should

Retrieved on: 
Thursday, August 31, 2023
Nausea, Acetate, Pregnancy, Headache, Life, STI, Friends, IUD, Pharmacy, Tubing (recreation), Method, Ovulation, Birth, Abortion, Levonorgestrel, Uterus, Tablet, Vomiting, Dizziness, Risk, Fertility, Quarterlife, Ulipristal acetate, Menstrual cycle, Chronic pain, Condom, NHS, Mental health, Family, Environment, Birth control

Whatever the reason, if you need to prevent an unplanned pregnancy you might decide to use emergency contraception.

Key Points: 
  • Whatever the reason, if you need to prevent an unplanned pregnancy you might decide to use emergency contraception.
  • For emergency IUD fittings, you need to go to a contraceptive and sexual health clinic, or your GP or gynaecologist.
  • This article is part of Quarter Life, a series about issues affecting those of us in our twenties and thirties.

How does it work?

    • Levonorgestrel and ulipristal both work by delaying ovulation.
    • This means that if there are sperm inside the fallopian tubes, there won’t be an egg for them to meet and fertilise.
    • In a typical menstrual cycle, you’re most at risk of pregnancy on days nine to 14.
    • But even if you’re more than halfway through your typical monthly cycle, these tablets can still work.

How effective is it?

    • While it’s the most effective form of emergency contraception, it can be uncomfortable or even painful to have an IUD fitted.
    • It’s at least 95% effective at stopping pregnancies when taken within this time frame.
    • Levonorgestrel is 95% effective at preventing pregnancy if taken within 24 hours of unprotected sex.
    • But both tablets are up to 95% effective at stopping pregnancies when taken soon after unprotected sex.

What should you expect?

    • It may also cause your next period to begin earlier or later than normal.
    • Ectopic pregnancy (when a fertilised egg implants in a fallopian tube) may be possible if emergency contraception fails.
    • It’s also worth noting that emergency contraceptives have no effect on long-term fertility and can be used even if you plan to have children later on.

Agile Therapeutics Announces the Availability of Twirla® to MMCAP Infuse Members

Retrieved on: 
Monday, June 26, 2023
Growth, City, Partnership, GPO, Therapy, Agile, Levonorgestrel, Patient, MMCAP, Pharmaceutical industry, Contraceptive patch

PRINCETON, N.J., June 26, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that Twirla will become available to MMCAP Infuse Members effective July 1, 2023. The Company expects this increased availability to positively impact growth of demand and factory sales in the non-retail channel, which grew 20% and 15% respectively from the fourth quarter 2022 to first quarter 2023.

Key Points: 
  • Twirla (levonorgestrel and ethinyl estradiol) transdermal system will be made available nationwide to members of MMCAP Infuse, effective July 1, 2023
    PRINCETON, N.J., June 26, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that Twirla will become available to MMCAP Infuse Members effective July 1, 2023.
  • “We expect to see accelerated growth in the Twirla non-retail channel by partnering with MMCAP Infuse, a national cooperative GPO for government facilities that provides contracts for healthcare products and services, including birth control products,” said Agile Therapeutics’ Chief Commercial Officer Amy Welsh.
  • MMCAP Infuse has over 26,000 member facilities in all 50 states, including state agencies, counties, cities, and school districts,.
  • This partnership with MMCAP Infuse reinforces Agile’s commitment to making Twirla available to as many patients as possible.

Agile Therapeutics Announces the Availability of Twirla® through FPA Women’s Health

Retrieved on: 
Thursday, June 15, 2023
Health, Levonorgestrel, Growth, Therapy, FPA, Birth control, Contraceptive patch

PRINCETON, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that Twirla will become available through FPA Women’s Health. The Company expects this increased availability to positively impact growth of demand and factory sales in the non-retail channel, which grew 20% and 15% respectively from the fourth quarter 2022 to first quarter 2023.

Key Points: 
  • FPA Women’s Health is the largest independent family planning service network in the United States, and the Twirla (levonorgestrel and ethinyl estradiol) transdermal system is now the exclusive patch dispensed within FPA clinics in California
    PRINCETON, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that Twirla will become available through FPA Women’s Health.
  • The Company expects this increased availability to positively impact growth of demand and factory sales in the non-retail channel, which grew 20% and 15% respectively from the fourth quarter 2022 to first quarter 2023.
  • As California’s leading provider of in-clinic and telehealth women’s healthcare, FPA Women’s Health has 24 locations throughout Los Angeles County and other regions across California.
  • “We are thrilled to be the exclusive patch dispensed within FPA’s California clinics, and we expect to tap into a significant proportion of Twirla’s target population through the FPA network,” says Chief Commercial Officer Amy Welsh, “a connection that was made with the help of our partners at Afaxys.”
    Agile continues to prioritize strategic partnerships that have the potential to efficiently and effectively grow Twirla while simultaneously allowing the Company to responsibly manage its operating expenses.

Curae Pharma360 Promotes Autumn Ehnow to Chief Executive Officer

Retrieved on: 
Tuesday, June 13, 2023
Levonorgestrel, Policy, MD, Operational definition, IUD, Doctor of Philosophy, OTC, Management, Pharmaceutical industry, Growth, Cura del Popolo

SAN FRANCISCO, June 13, 2023 /PRNewswire/ -- Curae Pharma360 (Curae), a mission-driven pharmaceutical company strengthening access to and affordability of life-changing generic medicines, announced today it has promoted Autumn Ehnow to Chief Executive Officer. A founding leader of Curae and its Chief Operating Officer since the company's inception last year, Ehnow will continue to serve as Executive Vice President, Policy & Strategic Market Access at Medicines360, the nonprofit parent company of Curae.

Key Points: 
  • Ehnow's Leadership and Operational Expertise to Drive Curae's Growth, Partnerships, and Product Portfolio
    SAN FRANCISCO, June 13, 2023 /PRNewswire/ -- Curae Pharma360 (Curae), a mission-driven pharmaceutical company strengthening access to and affordability of life-changing generic medicines, announced today it has promoted Autumn Ehnow to Chief Executive Officer.
  • A founding leader of Curae and its Chief Operating Officer since the company's inception last year, Ehnow will continue to serve as Executive Vice President, Policy & Strategic Market Access at Medicines360, the nonprofit parent company of Curae.
  • Ehnow, who had a major role establishing the commercial operations at Curae, brings two decades of experience as a pharmaceutical and nonprofit leader to the CEO role.
  • "Autumn's expertise is exactly what Curae needs in a leader," said Andrea Olariu, MD, PhD, CEO of Medicines360.

Public advisory - Unauthorized drugs for abortion and emergency contraception sold illegally on "Dr. Pooja" websites

Retrieved on: 
Tuesday, May 16, 2023
Infection, DIN, Pregnancy, Asthma, Mifepristone, Pharmacy, Misoprostol, Health Canada, Medical abortion, Levonorgestrel, Coagulopathy, Uterus, Sale, Plasma protein binding, Abortion, NPN, Patient, Risk, Allergy, Drug identification number, Natural product, Birth, Health, Safety, Birth control, Dietary supplement

Health Canada is aware (link available in French only) of two "Dr. Pooja" websites ( https://www.drpoojaclinic.ca/ and http://drpoojacliniccynaecologist.com/ ) selling unauthorized prescription drugs for medical abortion labelled to contain mifepristone and misoprostol, and unauthorized over-the-counter drugs for emergency contraception labelled to contain levonorgestrel.

Key Points: 
  • Health Canada is aware (link available in French only) of two "Dr. Pooja" websites ( https://www.drpoojaclinic.ca/ and http://drpoojacliniccynaecologist.com/ ) selling unauthorized prescription drugs for medical abortion labelled to contain mifepristone and misoprostol, and unauthorized over-the-counter drugs for emergency contraception labelled to contain levonorgestrel.
  • Selling unauthorized health products in Canada is illegal, and Health Canada will do everything it can to stop this activity.
  • Unauthorized drugs may have no active ingredients, the wrong ingredients, or dangerous additives such as prescription drugs not listed on the label.
  • Health Canada has directed the websites to stop selling unauthorized health products and is working to have the websites removed.

Emergency contraception is often confused with abortion pills – here's how Plan B and other generic versions work to prevent pregnancy

Retrieved on: 
Wednesday, April 19, 2023
People, Rape, Survivor, Ulipristal acetate, Pregnancy, IUD, Pharmacy, Rite Aid, Misoprostol, Birth, Ovulation, Gestational sac, Abortion, Woman, Levonorgestrel, Intrauterine device, Uterus, Child care, Sale, Hormonal intrauterine device, Supreme, Roe v. Wade, Copper, Mifepristone, Time, Supreme court, Plan B, Copper IUD, Law of the United Kingdom, Parental consent, Confusion, Condom, Transport, Health, FDA, Mucus, Egg, Birth control, Amazon, Walmart

Attempting to control inventory, Amazon, Rite Aid and Walmart have imposed purchase limits on the emergency contraception known as Plan B since the Supreme Court’s ruling.

Key Points: 
  • Attempting to control inventory, Amazon, Rite Aid and Walmart have imposed purchase limits on the emergency contraception known as Plan B since the Supreme Court’s ruling.
  • Several legislators and proposed bills have conflated emergency contraception with abortion and are trying to limit access to it.
  • As a researcher of women’s sexual and reproductive health and decision-making, I have extensively researched access to emergency contraception.

What is emergency contraception?

    • Emergency contraception can take the form of pills – sometimes called the morning-after pill – or an intrauterine device, or IUD that delays ovulation.
    • There are two types of emergency contraception pills.
    • The second type of emergency contraception pill is ulipristal acetate, which is sold under the brand name ella.
    • Both Paragard and Mirena IUDs have been approved by the FDA for use as contraception, but they are not yet approved specifically for use as emergency contraception.

How is emergency contraception different from the abortion pill?

    • There has been confusion about whether emergency contraception is an abortifacient – that is, a medication that triggers an abortion.
    • The key difference is that the abortion pill works only when a woman is pregnant, and emergency contraception works only when she is not.
    • The so-called abortion pill is used for a medication abortion and actually consists of two separate pills that do different things.

How do abortion restrictions jeopardize emergency contraception?

    • With the increase in abortion restrictions, access to a full range of contraceptive options – including emergency contraception – is more critical than ever.
    • There are already numerous barriers to obtaining emergency contraception in a timely manner.
    • The most effective types of emergency contraception, ulipristal acetate and both hormonal and nonhormonal IUDs, must be obtained from a health care provider.
    • People also encounter high rates of misinformation about when to take levonorgestrel for maximum effectiveness and about sales restrictions.

What are the benefits of emergency contraception?

    • Access to emergency contraception promotes women’s health in several ways.
    • Nearly half of pregnancies in the U.S. are unintended, and emergency contraception can prevent about 95% of unwanted or mistimed pregnancies when used within five days of sex.
    • Overall, access to a full range of contraceptive options – including emergency contraception – gives women greater control over their reproductive choices.

Sebela Women's Health Shares Findings from a Real-World Cost Comparison of Hormonal and Non-hormonal IUD Use Among Privately Insured Individuals in the U.S.

Retrieved on: 
Tuesday, March 21, 2023
Database, University, Obstetrics, IUD, Associate professor, Obstetrics and gynaecology, Birth, Woman, Levonorgestrel, Intrauterine device, Bayer, Incidence, Patient, The Cooper Companies, Gynaecology, Ageing, Copper, FDA, Aetna Health Inc. v. Davila, Medicine, Birth control, Pharmaceutical industry, LNG

ROSWELL, Ga., March 21, 2023 /PRNewswire/ -- Sebela Women's Health Inc, a part of Sebela Pharmaceuticals, will present findings from a post-hoc comparison of payer costs for hormonal and non-hormonal intrauterine devices (IUDs) during the Academy of Managed Care Pharmacy Congress, March 21-24, 2023, in San Antonio, TX. Seven years of U.S. commercial claims data were analyzed to improve estimates of long-term, real-world costs, with specific attention to costs related to IUD complications and device removals.

Key Points: 
  • The study included paid claims from individuals aged 12-45 years who had an IUD inserted in 2014 and were continuously enrolled for one year prior and after the insertion of a new IUD.
  • The cohort included 45,709 (72.1%) individuals with a hormonal IUD (13.5mg [Skyla®] or 52mg levonorgestrel (LNG)-releasing [Mirena®]) and 8,035 (12.7%) with a non-hormonal (copper-based [Paragard®]) IUD.
  • The data—obtained from MarketScan®, a commercial claims database from Merative™—were examined using diagnosis codes for procedures and services related to IUD use.
  • Costs due to complications incorporated any paid claims associated with known adverse events during the time of IUD use.

EQS-News: This Biotech Company is Pursuing Positive Cash Flow In 2023

Retrieved on: 
Sunday, January 22, 2023
Agile, Health minister, Buttocks, Advertising, Freedom, Food, Therapy, Levonorgestrel, Planned Parenthood, Organization, Skin, Abdomen, Parenthood, OPEX, Patient, NYSE, Birth, Prescription, Contraceptive patch, CTV, Health, FDA, Pharmacy, Conference, Food and Drug Administration, Woman, Pharmaceutical industry, Birth control, Video game, Dietary supplement, Princeton University

Biotech company Agile Therapeutics Inc. (NASDAQ: AGRX) began selling its contraceptive patch in 2021, and the company is pursuing positive cash flow by the end of 2023.

Key Points: 
  • Biotech company Agile Therapeutics Inc. (NASDAQ: AGRX) began selling its contraceptive patch in 2021, and the company is pursuing positive cash flow by the end of 2023.
  • About 80% choose to adhere it to their buttocks or lower abdomen, according to the company.
  • Agile has also expressed a desire to acquire or license another commercial women’s health product, which could potentially accelerate the timeline to generating positive cash flow.
  • “Our job now is to continue growing Twirla, achieve positive cash flow, and deliver shareholder value.”
    Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women.