Opill

Last updated
Opill
Opill (10-08-204).jpg
Background
TypeProgestin-only Pill
First useMarch 2024
Pregnancy rates (first year)
Perfect use2%
Typical use9%
Usage
User remindersDaily, within the same 3 hour period
Advantages and disadvantages
STI protectionNo
BenefitsOTC, no prescription required

Opill is a birth control pill formulated from norgestrel, which works to thicken the cervical mucus and prevent pregnancy. [1] Opill is manufactured by HRA Pharma and is the first ever over-the-counter contraceptive to be sold in the United States. [2] Opill is solely intended to be used for pregnancy prevention. It is not intended for use in emergency situations or for prevention of sexually transmitted diseases or infections. [3] Opill is marketed through social media and its partnership with the Women's National Basketball Association (WNBA). [4]

Contents

History

Opill was acquired by Perrigo during their acquisition of HRA Pharma, along with ellaOne and Hana, other over-the-counter emergency contraceptives. [5]

Opill was approved by the Food and Drug Administration (FDA) for over-the-counter use on July 13, 2023. [2] This approval was given to its manufacturer a year after their initial application for the prescription to over-the-counter switch. [6] This came a year after the overturning of Roe v. Wade, which heavily restricted or criminalized abortion in 24 states. [7]

Opill began sale at major retailers in the U.S., including CVS, Target, Walgreens, and Walmart in March 2024. It is also available online from the Opill website and Amazon. [8]

Product

Opill is a progestin-only daily birth control pill, also known as a “mini pill,” available over-the-counter without the need for health insurance. [1] [3] It has no age restrictions and is safe to use as long as menstruation has started. The pill should be taken orally at the same time each day for optimal effectiveness; it is 98% effective when taken correctly and 91% effective with typical use. [1] [9] Opill begins working 48 hours after the first dose. [10]

Opill is intended solely as a contraceptive and does not function as emergency contraception, provide protection against sexually transmitted infections (STIs), or act as an abortion medication. [3] Common side effects include irregular vaginal bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, bloating, and cramping. [2]

Opill can be purchased online through the company’s website or found in the family planning aisles of most drug stores, convenience stores, and grocery stores. Opill's presence in the family planning aisle could help reduce the U.S.' unplanned pregnancy rate of 41.6% as of 2019. [11] [12]

Marketing

When it comes to testing and labeling, Opill used several surveys to make sure that consumers could follow the instructions on dosing and understand the package labels. [13] This is an important step to the brand since consumers take the medication without doctor supervision. The colors of the packaging are also designed with the idea of avoiding gender-based stereotypes. They use a variety of colors, mainly teal with accents of blue, purple, and pink. [13] This variety of bright colors not only sets Opill apart, but it helps consumers gain brand recognition.

Opill also works with Snapchat to spread awareness to Generation Z. The results of the campaign report an increase in brand awareness by 24%. [14] According to Leila Bahbah, US Women's Health Brand Lead and Associate Director of Opill, Snapchat was a key player in reaching Gen Z audiences. [14]

In April 2024, Perrigo partnered with The Women's National Basketball Association to work together to build confidence and health equity. Colie Edison, Chief Growth Officer for the WNBA, said that the WNBA is dedicated to addressing issues important to the organization such as reproductive health. [4] This is why this multi-year partnership aligns with both Perrigo and WNBA's core beliefs. They are working to increase accessibility and reach students on college campuses across the country. [4]

Scientific foundation

Norgestrel is a progestin used in birth control pills, such as the Opill, which contains a synthetic version of the naturally occurring hormone progesterone. [1] [15] The Opill contains 0.075mg of the active ingredient norgestrel, along with inactive ingredients including cellulose, FD&C Yellow 5, lactose, magnesium stearate, and polacrilin potassium. [16]

The Opill primarily works by thickening the cervical mucus, making it harder for sperm to reach the egg. [10] [17] It can also prevent the release of eggs from the ovaries during some menstrual cycles and thins the uterine lining, creating a less hospitable environment for a fertilized egg to implant. [10] [16]

Progesterone plays a crucial role in preventing pregnancy by stopping ovulation. It works by inhibiting the development of ovarian follicles, preventing the release of an egg. This process is regulated by negative feedback on the hypothalamus, reducing the secretion of hormones like follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Without follicle development, estradiol levels remain low and the LH surge necessary for ovulation is blocked, effectively preventing ovulation. [16] [18]

Availability

Opill is currently available in all states in the U.S. after it was approved by the FDA on July 13, 2023. The active ingredient in Opill, Norgestrel, was legalized for prescription use in 1973. However, it was discontinued by the manufacturer in 2005. [1] Opill is available in major retailers like Walmart, Target, CVS, and Walgreens. In stores, a one month supply is sold for $19.99, and a three month supply is sold for 49.99. [19] Perrigo also offers a "Cost Assistance Reduction" program for those that are eligible.

Currently, there are no legal restrictions placed on the Opill, however, that could change as it did with the oral abortion pill Mifepristone. [11]

World wide, over-the-counter birth control is legal in most of Africa, South America, and Asia. However, in most of Europe it still requires a prescription. [20]

Related Research Articles

<span class="mw-page-title-main">Emergency contraception</span> Birth control measures taken after sexual intercourse

Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy.

<span class="mw-page-title-main">Combined oral contraceptive pill</span> Birth control method which is taken orally

The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. It is the oral form of combined hormonal contraception. The pill contains two important hormones: a progestin and estrogen. When taken correctly, it alters the menstrual cycle to eliminate ovulation and prevent pregnancy.

<span class="mw-page-title-main">Levonorgestrel</span> Hormonal medication used for birth control

Levonorgestrel is a hormonal medication which is used in a number of birth control methods. It is combined with an estrogen to make combination birth control pills. As an emergency birth control, sold under the brand names Plan B One-Step and Julie, among others, it is useful within 72 hours of unprotected sex. The more time that has passed since sex, the less effective the medication becomes, and it does not work after pregnancy (implantation) has occurred. Levonorgestrel works by preventing ovulation or fertilization from occurring. It decreases the chances of pregnancy by 57–93%. In an intrauterine device (IUD), such as Mirena among others, it is effective for the long-term prevention of pregnancy. A levonorgestrel-releasing implant is also available in some countries.

The Yuzpe regimen is a method of emergency contraception that uses a combination of ethinyl estradiol and levonorgestrel, specifically 1 mg of norgestrel and 100 mcg of ethinyl estradiol ASAP and again in 12 hrs. It is less effective and less commonly used than a larger dose of levonorgestrel alone, a dose of ulipristal acetate, or insertion of a copper intrauterine device. It is designed to be used within 72 hours of unprotected sexual intercourse because it works by inhibiting ovulation.

<span class="mw-page-title-main">Contraceptive patch</span> Transdermal patch applied to prevent pregnancy

A contraceptive patch, also known as "the patch", is a transdermal patch applied to the skin that releases synthetic oestrogen and progestogen hormones to prevent pregnancy. They have been shown to be as effective as the combined oral contraceptive pill with perfect use, and the patch may be more effective in typical use.

Progestogen-only pills (POPs), colloquially known as "mini pills", are a type of oral contraceptive that contain synthetic progestogens (progestins) and do not contain estrogens. They are primarily used for the prevention of undesired pregnancy, although additional medical uses also exist.

Extended or continuous cycle combined oral contraceptive pills are a packaging of combined oral contraceptive pills (COCPs) that reduce or eliminate the withdrawal bleeding that would occur once every 28 days in traditionally packaged COCPs. It works by reducing the frequency of the pill-free or placebo days. Extended cycle use of COCPs may also be called menstrual suppression, although other hormonal medications or medication delivery systems may also be used to suppress menses. Any brand of combined oral contraceptive pills can be used in an extended or continuous manner by simply discarding the placebo pills; this is most commonly done with monophasic pills in which all of the pills in a package contain the same fixed dosing of a synthetic estrogen and a progestin in each active pill.

<span class="mw-page-title-main">Drospirenone</span> Medication drug

Drospirenone is a progestin and antiandrogen medication which is used in birth control pills to prevent pregnancy and in menopausal hormone therapy, among other uses. It is available both alone under the brand name Slynd and in combination with an estrogen under the brand name Yasmin among others. The medication is an analog of the drug spironolactone. Drospirenone is taken by mouth.

<span class="mw-page-title-main">Norgestrel</span> Progestin medication used for birth control

Norgestrel, sold under the brand name Opill among others, is a progestin which is used in birth control pills. It is often combined with the estrogen ethinylestradiol, marketed as Ovral. It is also used in menopausal hormone therapy. It is taken by mouth.

<span class="mw-page-title-main">Hormonal contraception</span> Birth control methods that act on the endocrine system

Hormonal contraception refers to birth control methods that act on the endocrine system. Almost all methods are composed of steroid hormones, although in India one selective estrogen receptor modulator is marketed as a contraceptive. The original hormonal method—the combined oral contraceptive pill—was first marketed as a contraceptive in 1960. In the ensuing decades, many other delivery methods have been developed, although the oral and injectable methods are by far the most popular. Hormonal contraception is highly effective: when taken on the prescribed schedule, users of steroid hormone methods experience pregnancy rates of less than 1% per year. Perfect-use pregnancy rates for most hormonal contraceptives are usually around the 0.3% rate or less. Currently available methods can only be used by women; the development of a male hormonal contraceptive is an active research area.

<span class="mw-page-title-main">Beginning of pregnancy controversy</span> Cultural-linguistic, not scientific question

Controversy over the beginning of pregnancy occurs in different contexts, particularly as it is discussed within the debate of abortion in the United States. Because an abortion is defined as ending an established pregnancy, rather than as destroying a fertilized egg, depending on when pregnancy is considered to begin, some methods of birth control as well as some methods of infertility treatment might be classified as causing abortions.

<span class="mw-page-title-main">Birth control</span> Method of preventing human pregnancy

Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unintended pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth control only became available in the 20th century. Planning, making available, and using human birth control is called family planning. Some cultures limit or discourage access to birth control because they consider it to be morally, religiously, or politically undesirable.

Birth control pills come in a variety of formulations. The main division is between combined oral contraceptive pills, containing both estrogens and synthetic progestogens (progestins), and progestogen only pills. Combined oral contraceptive pills also come in varying types, including varying doses of estrogen, and whether the dose of estrogen or progestogen changes from week to week.

<span class="mw-page-title-main">Ulipristal acetate</span> Chemical compound

Ulipristal acetate, sold under the brand name Ella among others, is a medication used for emergency contraception and uterine fibroids. As emergency contraception it should be used within 120 hours of vaginally penetrating intercourse. For fibroids it may be taken for up to six months. It is taken by mouth.

<span class="mw-page-title-main">Drospirenone/ethinylestradiol/levomefolic acid</span> Pharmaceutical combination

Drospirenone/ethinylestradiol/levomefolic acid (EE/DRSP/LMF), sold under the brand name Beyaz among others, is a combination of ethinylestradiol (EE), an estrogen, drospirenone (DRSP), a progestogen, antimineralocorticoid, and antiandrogen, and levomefolic acid (LMF), a form of vitamin B9, which is used as a birth control pill to prevent pregnancy in women. The formulation contains folate as the calcium salt of levomefolic acid to lower the risk of complications such as fetal neural tube defects should the medication fail as a form of birth control. EE/DRSP/LMF was approved for use by the US Food and Drug Administration (FDA) in September 2010.

<span class="mw-page-title-main">Birth control in the United States</span>

Birth control in the United States is available in many forms. Some of the forms available at drugstores and some retail stores are male condoms, female condoms, sponges, spermicides, over-the-counter progestin-only contraceptive pills, and over-the-counter emergency contraception. Forms available at pharmacies with a doctor's prescription or at doctor's offices are oral contraceptive pills, patches, vaginal rings, diaphragms, shots/injections, cervical caps, implantable rods, and intrauterine devices (IUDs). Sterilization procedures, including tubal ligations and vasectomies, are also performed.

The first large-scale human trial of the birth control pill was conducted by Gregory Pincus and John Rock in 1955 in Puerto Rico. Before the drug was approved as safe in the mainland U.S., many Puerto Rican women were used as test subjects. These trials are a major component in the history of the development of female oral contraceptives, occurring in between initial small trial testing on the east coast and the release of the drug for public consumption. As a result, women gained more independence as they were able to delay pregnancies. The trials are controversial because the Puerto Rican women were uninformed of the potential health and safety risks of the drug. There was a large amount of criticism coming from feminist circles surrounding the trial.

<span class="mw-page-title-main">Ethinylestradiol/etonogestrel</span> Pharmaceutical birth control combination

Ethinylestradiol/etonogestrel, sold under the brand names NuvaRing among others, is a hormonal vaginal ring used for birth control and to improve menstrual symptoms. It contains ethinylestradiol, an estrogen, and etonogestrel, a progestin. It is used by insertion into the vagina. Pregnancy occurs in about 0.3% of women with perfect use and 9% of women with typical use.

<span class="mw-page-title-main">Combined hormonal contraception</span> Form of hormonal contraception combining both an estrogen and a progestogen

Combined hormonal contraception (CHC), or combined birth control, is a form of hormonal contraception which combines both an estrogen and a progestogen in varying formulations.

There are many types of contraceptive methods available in France. All contraceptives are obtained by medical prescription after a visit to a family planning specialist, a gynecologist or a midwife. An exception to this is emergency contraception, which does not require a prescription and can be obtained directly in a pharmacy.

References

  1. 1 2 3 4 5 Research, Center for Drug Evaluation and (2024-07-12). "Opill (0.075mg Oral Norgestrel Tablet) Information". FDA.
  2. 1 2 3 Commissioner, Office of the (2024-08-09). "FDA Approves First Nonprescription Daily Oral Contraceptive". FDA. Retrieved 2024-10-07.
  3. 1 2 3 "Five Things to Know About Opill, the First FDA-Approved Over-the-Counter Birth Control Pill". NYU Langone News. Retrieved 2024-10-06.
  4. 1 2 3 "Opill and WNBA Team Up for Groundbreaking Partnership". Opill.
  5. ↑ "Perrigo to Acquire Leading Consumer Self-Care Company, HRA Pharma". Perrigo InvestorRoom. Retrieved 2024-10-07.
  6. ↑ "Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill - Drugs.com MedNews". Drugs.com. Retrieved 2024-10-07.
  7. ↑ "Six Months Post-Roe, 24 US States Have Banned Abortion or Are Likely to Do So: A Roundup | Guttmacher Institute". www.guttmacher.org. 2023-01-09. Retrieved 2024-10-07.
  8. ↑ Lupkin, Sidney (2024-03-04). "First over-the-counter birth control pill now for sale online". NPR . Retrieved 2024-10-06.
  9. ↑ "What you need to know about Opill, the first over-the-counter birth control | OHSU". www.ohsu.edu. Retrieved 2024-10-06.
  10. 1 2 3 "About Opill | The First Over-the-Counter Birth Control Pill". Opill. Retrieved 2024-10-06.
  11. 1 2 "Opill: The First Over-the-Counter Daily Oral Contraceptive | Johns Hopkins | Bloomberg School of Public Health". publichealth.jhu.edu. 2023-07-13. Retrieved 2024-10-07.
  12. ↑ CDC (2024-05-20). "Unintended Pregnancy". Reproductive Health. Retrieved 2024-10-07.
  13. 1 2 "Our Story". Opill.
  14. 1 2 "How Opill Made Birth Control More Accessible With Snapchat Ads". Snapchat Business.
  15. ↑ Pitkin, R. M. (August 1995). "Editorial". Obstetrics & Gynecology. 86 (2): 293. doi:10.1016/0029-7844(95)00162-k. ISSN   0029-7844. PMID   7617364.
  16. 1 2 3 “Opill Tablets.” FDA Data Access, FDA, www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf. Accessed 6 Oct. 2024.
  17. ↑ "What You Need to Know About Opill, the First FDA-Approved Over-the-Counter Birth Control Pill | University of Utah Health". healthcare.utah.edu. 2023-07-28. Retrieved 2024-10-06.
  18. ↑ Cooper, Danielle B.; Patel, Preeti (2024-02-29), "Oral Contraceptive Pills", StatPearls [Internet], StatPearls Publishing, PMID   28613632 , retrieved 2024-10-06
  19. ↑ "Opill, first U.S. over-the-counter birth-control pill, to hit stores: What to know". Washington Post. 2024-03-05. Retrieved 2024-10-06.
  20. ↑ "OTC Access World Map". Free The Pill. Retrieved 2024-10-06.
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