Friday, April 19, 2024

Fda Approved Non Hormonal Birth Control

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How Does Phexxi Work

Non-hormonal birth control gel gets US FDA nod

“It the bodys own natural, vaginal environment to act as a contraceptive method,” she explained.

She added that Phexxi is “highly viscous,” so it doesn’t leak during sex, and it leaves the body with the sperm and other vaginal fluids.

Phexxi does not protect against sexually transmitted diseases or infections.

What About Side Effects

  • The most common side effect is irritation of the vulva and vaginal area, such as a burning or an itching sensation. Nearly a third of women reported one of these symptoms.
  • Less than 1% of women had more serious side effects, such as severe urinary tract infection.
  • Nearly 10% of male partners reported some itching, burning, or pain as well after their partner used Phexxi.

Phexxi cannot prevent sexually transmitted infections , so women should continue to use condoms to prevent STIs.

Birth Control Gel Approved As First No

A new birth control gel is the first non-hormonal contraceptive to win FDA approval in decades, bringing another option to the $5.4 billion market.

The approval marks a rare new option in the contraceptive market, which has been dominated by pills for the past 60 years. The last wholly new type of birth control without hormones was the female condom, approved in 1993.

This is for women who arent using hormonal contraceptive, who want to prevent against pregnancy and wont use an IUD , Evofem Chief Executive Officer Saundra Pelletier said by telephone. Our product is the only contraceptive product with no hormones, with no systemic side effects, and that women use only when they need it.

Oppenheimer analyst Leland Gershell, who recommends investors buy shares, forecast annual sales in the U.S. could reach $440 million by 2024. The company is still working on the exact pricing, which is expected to be in-line with branded birth control pills. However, it anticipates health insurance companies will pay between $250 and $275 per pack of 12 prefilled applicators.

Rather than replace or compete with the pill out of the gate, Pelletier said the company is looking to first target the 17 million U.S. women who identify as beyond hormone, meaning they either dont want to use or cant use a hormonal contraceptive.

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Short Acting Hormonal Methods

Prevent pregnancy by interfering with ovulation and possibly fertilization of the egg. If you want to get pregnant, you can stop using them at any time.

Combination Oral ContraceptivesThe Pill

What is it?

  • A pill that has two hormones to stop the ovaries from releasing eggs
  • It also thickens the cervical mucus, which keeps sperm from getting to the egg.

How do I use it?

  • You should swallow the pill at the same time every day, whether or not you have sex.
  • If you miss one or more pills, or start a pill pack too late, you may need to use another method of birth control, like a condom and spermicide

How do I get it?

  • You need a prescription from a healthcare provider.

Chance of getting pregnant with typical use

  • Out of 100 women who use this method, about 9 may get pregnant.

Some Side Effects

  • Spotting or bleeding between periods

Less Common Serious Side Effects

  • It is not common, but some women who take the pill develop high blood pressure.
  • It is rare, but some women will have blood clots, heart attacks, or strokes.

Does it protect me from sexually transmitted infections ? No.

  • A pill that has only one hormone, a progestin.
  • It thickens the cervical mucus, which keeps sperm from getting to the egg.
  • Less often, it stops the ovaries from releasing eggs.

How do I use it?

How do I get it?

  • You need a prescription from a healthcare provider.

Chance of getting pregnant with typical use (Number of pregnancies expected per 100 women who use this method for one year

Some Side Effects

Where’s The Demand For New Birth Control

This FDA

The Roe decision amplifies the urgency.

With more open conversation about contraceptive needs, the next decade could be an exciting time for nonhormonal contraception, Lai said. These conversations, he believes, could help pharmaceutical investors see a real demand.

NIH funds early stage nonhormonal birth control research, but Johnston agreed that investment in the methods isnt where it needs to be. Products cant get to pharmacy shelves unless the biopharma industry steps in to fund drug development, but its difficult to determine how many women want hormone-free birth control options. Pharmaceutical companies usually want to see clear demand before investing in a product.

Worldwide, there were more than 151 million users on the hormonal pill in 2019, according to to a report from the United Nations. Analysts say sales of all hormonal contraceptives made the global market for these options worth more than $15 billion in 2020 a value thats estimated to grow to more than $20 billion by 2030.

From a business perspective, the contraceptive market seems to be healthy and growing, reads a 2020 commentary in the journal Nature. Yet the demand from women for transformational change is not reflected as a reduction in sales.

Hormonal contraceptives work tremendously well, said Johnston. But they basically involve the changing of the expression of hundreds, if not thousands, of genes, to give you the effect.

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What Are The Benefits Of Hormone

Birth control containing the hormone estrogen can increase your risk of blood clots, stroke, and high blood pressure, and has been linked to increased risk of breast cancer andovarian cancer. With hormone-free birth control, such as Phexxi, you wont experience any of the side effects common with such contraceptives .

Non-hormonal birth control such as condoms offer protection from sexually transmitted infections like gonorrhea and chlamydia that hormonal options dont protect from. Though they dont protect you from STDs, non-hormonal IUDs can be used long-termfor 3-12 years.

The Latest In Contraceptives For 2022

A presentation at the 2022 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting discussed the recent updates in contraceptives including new nonhormonal intrauterine devices.

The latest and greatest in contraception, including new nonhormonal intrauterine devices and male birth control, was discussed during a presentation on updates in contraception at the 2022 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting held in San Diego, California from May 6-8.1

Kathleen Morrell, MD, MPH, director of Family Planning Division and residency program director in the Department of Obstetrics & Gynecology at Maimonides Medical Center in Brooklyn, New York, first outlined the IUDs that were just approved for use extension by the US Food and Drug Administration .

This includes Mirena , which was approved to prevent pregnancy for up to 7 years by the FDA on August 11, 2021. Previously, Mirena was approved for use for up to 6 years. The approval was based on the Mirena Extension Trial, a multicenter study investigating the efficacy in preventing pregnancy, as well as treating heavy menstrual bleeding. Bayer plans on seeking approval for use for up 8 years.

Another IUD that was recently given approval for extended use is Liletta , which is now approved for up to 6 years and is expected to see a 7-year approval relatively soon.

Whats new on the market

Whats in the pipeline?

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Are There Side Effects

Phexxi’s most common side effectvaginal burningis uncommon with other types of contraceptives. During the clinical trial, 18% of users experienced vaginal burning, while 14.5% reported vaginal itching.

Other reported side effects include:

  • Vaginal infection
  • Painful urination

Ultimately, it’s important to talk to your healthcare provider about potential birth control benefits and side effects to determine what works best for you.

“I think its great to have another choice in the market,” Chen said. “But the bottom line is that women really have to take charge of their own bodies and their own health and actually see a doctor.”

Evofem Terms Of Service For Phexxicom

The Tech Behind the First FDA-Approved Birth Control App

The website Phexxi.com is provided by Evofem Biosciences, Inc. to provide information and selected functionality to interested parties and provides important information related to the unmet needs that women face today with the lack of non-hormonal contraceptive options and a product that is in development to meet those needs. Healthcare professionals can provide their contact information to engage in communications with Evofem.

PLEASE READ THESE TERMS OF SERVICE AND OUR PRIVACY POLICY CAREFULLY BECAUSE THIS AGREEMENT CONSTITUTES A LEGALLY BINDING CONTRACT BETWEEN YOU AND EVOFEM. IF YOU DO NOT WISH TO ACCEPT THIS AGREEMENT, PLEASE DO NOT ACCESS OR USE THE SITE. BY ACCESSING, DOWNLOADING, USING, THE SITE, YOU AGREE TO BE BOUND BY THIS AGREEMENT, YOU ARE AT LEAST 18 YEARS OLD, YOU HAVE READ AND UNDERSTAND THIS AGREEMENT AND YOU ACCEPT THIS AGREEMENT.

NOTE: THESE TERMS CONTAIN A DISPUTE RESOLUTION AND ARBITRATION PROVISION, INCLUDING CLASS ACTION WAIVER THAT AFFECTS YOUR RIGHTS UNDER THESE TERMS AND WITH RESPECT TO DISPUTES YOU MAY HAVE WITH THE COMPANY. YOU MAY OPT OUT OF THE BINDING INDIVIDUAL ARBITRATION AND CLASS ACTION WAIVER AS PROVIDED BELOW.

1 MODIFICATION OF THIS AGREEMENT.

2 OWNERSHIP PROPRIETARY RIGHTS.

3 GUIDELINES USAGE RULES PROHIBITED CONDUCT AND USES.

3.1. YOU UNDERSTAND AND HEREBY ACKNOWLEDGE AND AGREE THAT YOU WILL NOT ENGAGE IN THE PROHIBITED CONDUCT AND USES LISTED BELOW . YOU WILL NOT:

3.1.2. use the Site if you are under the age of eighteen years old

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A Word From Get Meds Infos Medical Review Board

Phexxi is a new vaginal gel contraceptive. It is female-controlled and on-demand, meaning you only use it when you need it. Many women may like the fact that it is non-hormonal. This means it may have fewer side effects. But if you decide to try it, know that it is probably not as effective as IUDs or the pill. It also will not protect against STIs. Anju Goel, MD, MPH

Effectiveness Of Nonhormonal Birth Control Gel

When used as directed by a medical professional, Phexxi is 93 percent effective, according to the company. But in typical use , its effectiveness drops to 86 percent.

That means it may not work for roughly 14 out of every 100 people who use Phexxi as their sole method of birth control.

Nonhormonal birth control gel has a higher effectiveness than that of a male condom, female condom, or spermicide, per the FDA . However, its less effective at preventing pregnancy than oral contraception, the patch, shots, IUDs, or surgical sterilization.

Using Phexxi with some other types of birth control can make the gel more effective, though. While it cant be used with vaginal rings, it can be used with:

While Phexxi doesnt come with the same side effects as hormonal birth control, it does have certain risks.

The most common side effects of the nonhormonal birth control gel include:

  • vaginal burning, itching, or discomfort
  • yeast infections
  • bacterial vaginosis
  • vaginal discharge

In clinical studies of the gel, a few cases of bladder and kidney infections were reported, one of which was serious.

With that said, side effects are uncommon, and when they do happen, they tend to be mild. Fewer than 2 percent of participants in clinical trials stopped using Phexxi due to an adverse reaction, according to the manufacturer.

You should not use Phexxi if you or your partner are allergic to the birth controls ingredients, which include:

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How Much Does Phexxi Cost

Phexxi may not be covered by your health insurance. Without insurance, Phexxi costs $374 for 12, 5 gm of 1.8-1-0.4% gel*. You can save money on your prescription with a SingleCare coupon.

*Prescription prices change frequently. Search for Phexxi on singlecare.com for current prices before you go to the pharmacy.

A Different Nonhormonal Birth Control Option

Everything You

Until recently, people seeking hormone-free birth control have found few options available. The most effective and long-lasting nonhormonal option is the copper intrauterine device . Barrier methods sometimes are paired with spermicide to boost pregnancy prevention rates, or spermicides may be used alone . Apps and tests to track fertile days bring a high-tech sheen to the so-called rhythm method, but most ob/gyns do not recommend these as a way to prevent pregnancy.

Not until 2020 did the FDA approve a new nonhormonal birth control, Phexxi, which came on the market last fall. Should you try it if youre looking for a new option?

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Cervical Cap With Spermicide

What is it?

  • A soft latex or silicone cup with a round rim, which fits snugly around the cervix.

How do I use it?

  • You need to put spermicide inside the cap before you use it.
  • You must leave the cap in place for at least 6 hours after having sex.
  • You may leave the cap in for up to 48 hours.
  • You do NOT need to use more spermicide each time you have sex.

How do I get it?

  • First, a healthcare provider needs to determine the correct cervical cap size for you. Then you need a prescription for the device.

Chance of getting pregnant with typical use

  • Out of 100 women who use this method, about 17 to 23 may get pregnant.

Some Side Effects and Risks

  • Aabnormal Pap test

Some Less Common Risks

  • If you keep it in place longer than 48 hours, there is a risk of toxic shock syndrome. Toxic shock syndrome is a rare but serious infection.

Does it protect me from sexually transmitted infections ? No.

Does Phexxi Have Any Side Effects Or Risks

According to the FDA, the following symptoms or conditions are listed as potential side effects of using Phexxi:

  • Vaginal burning
  • Vulvovaginal pain

Phexxi isn’t perfect, and experts are particularly concerned about the 86% effectiveness.

“It doesn’t give ideal contraception, so if you are going to be having frequent intercourseand particularly if you are a young fertile womanI would suggest speaking with your health care provider to get a more effective contraceptive,” , a clinical professor of obstetrics and gynecology and reproductive sciences at Yale Medical School, told Health.

Dr. Minkin noted that more effective non-hormonal birth control options are available, such as the Paragard IUD. Also known as a Copper-T, the IUD is made of copper, which creates a toxic environment for sperm. “It gives them 99% effective contraception, has no hormones, and lasts for at least 10 years,” Dr. Minkin added.

The side effects can also make Phexxi a less-than-ideal choice for some. “Women prone to urinary tract infections or recurrent yeast infections should definitely check in with their doctor,” Dr. Wider said.

Overall, Phexxi adds one more birth control option to the table, which is never bad. “It’s a great addition for women who are seeking non-hormonal methods,” Dr. Wider said. And when more options are available, more women may use them to prevent pregnancy. As Dr. Levitt noted: “Anything is better than nothing.”

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Related: Patients And Doctors Are Clashing About Side Effects Of Hormonal Birth Control

These new contraceptives would be welcome news to women seeking alternative options, except many women lack access to them because they are not covered by many health insurance plans by dint of their not being included in the FDAs Birth Control Guide.

The Essential Health Benefits of the Affordable Care Act and regulations from the Department of Health and Human Services require insurers to cover preventive services and screenings for women as defined by the Health Resources and Services Administration . HRSAs guidance calls for all women to have access to the full range of contraceptive methods that are currently identified by the U.S. Food and Drug Administration.

And therein lies the problem.

At the time the ACA was implemented, no comprehensive regulatory document existed for contraceptive coverage. So federal agencies, health insurers, and pharmacy benefit managers turned to the FDA Birth Control Guide as formal guidance. Coverage has been determined this way ever since, even though the guide is out of date.

Some women find it difficult to remember to take a daily pill. Some dont want to have to go to a clinician to have an IUD inserted. Others have medical concerns or experience adverse effects such as mood changes, abnormal bleeding, or even cardiovascular or cancer risk that keep them from using other commonly accessible options or using hormones of any kind.

The FDA needs to step up to the plate.

How Do You Take It

Verify | No, over the counter daily birth control pills aren’t currently available in US

You only need to take Phexxi when you need it. It can be taken immediately before or up to one hour before sex.

According to Gersh, Phexxi “requires thoughtful use and preparation,” so it’s best suited for women who are prepared for some level of forethought.

Phexxi, which comes in a box of 12, will only be available through a prescription. If your insurance doesn’t cover it, it will cost about $250 to $275 per box, or $20 to $23 per dose.

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So Why Arent Doctors Prescribing It

The first time I tried hormonal birth control, I vomited into my college dormitory toilet for hours. That nausea continued for weeks. Weeks turned into months of trying one hormonal birth control pill after another. When my weight dropped below 105 lbs, my doctor told me it was time to admit

How To Use Phexxi

Phexxi can be used on its own or in tandem with other forms of birth control, including condoms, diaphragms, spermicide, intrauterine devices , and the Pill. However, Phexxi should not be used with vaginal rings like the NuvaRing, according to the FDA.

Phexxi’s ingredients are non-toxic and commonly found in food products. Lactic and citric acids are natural preservatives, and potassium bitartrate is better known as cream of tartar used in baking. That means it is safe to engage in mouth-to-vulva oral sex while using Phexxi. But be warned, Phexxi is acidic and has a very tart taste.

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