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    Home > Medical News > Medical World News > FDA approves first hormone-free contraceptive gel Phexxi contraceptive efficiency 93%

    FDA approves first hormone-free contraceptive gel Phexxi contraceptive efficiency 93%

    • Last Update: 2020-05-28
    • Source: Internet
    • Author: User
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    Evofem Biosciences is committed to developing and commercializing innovative products to meet the unmet needs of women's and reproductive healthThe U.SFood and Drug Administration (FDA) has approved Phexxi (L-lactic acid, citric acid and potassium citearate, vaginal gel) vaginal gel as an on-demand contraceptive method for women with reproductive potential to prevent pregnancy, the company announcedPhexxi is the first non-hormonal, on-demand, vaginal pH-regulating method, with a unique mechanism of action, can keep the vaginal pH within the normal range of 3.5-4.5, which is an acidic environment not suitable for spermPhexxis, a highly innovative contraceptive product, is the first and only over-the-counter prescription gel for pregnancy-prevention hormones, opening up a new category of female contraceptive methods that will give women control over their sexual and reproductive healthIt should be noted that Phexxis vaginal gels need to be used before sexual intercourse and cannot prevent pregnancy after sexual intercourseEvofem is expected to launch Phexxi in early September, along with the Phexxi Concierge Experience, a comprehensive patient and healthcare provider's telemedicine support system designed to provide on-demand educational support to doctors and accelerate and simplify women's access to Phexxi"The FDA's approval of Phexxis means that the women's community now has a non-hormonal contraceptive method that can be controlled at their own discretion and only use when needed," said Saundra Pelletier, ceo ofEvofemEmpowerment comes from innovation, and we are proud and excited to bring a transformative approach to birth control for women"
    Phexxi vaginal gel is a first-use (first-in-class) multi-purpose vaginal pH regulator (MVP-R) designed to regulate vaginal pH within the normal range of 3.5-4.5, even in the presence of semen (semen usually increases the vaginal pH to 7.0-8.0), thus maintaining a condition not suitable for sperm and certain viral and bacterial pathogens associated with sexually transmitted infections, but essential for vaginal health and acidic environments, Evofem Biosciences is currently developing Amphora vaginal gels for a variety of potential indications, including: prevention of female genitourinary dystoria chhelato infection, prevention of female gonorrhea Neisseria infectionThe top line of the IIb AMPREVENCE trial, published by Evofem Biosciences in December, showed that the study reached primary and secondary endpoints: Phexxi reduced the relative risk of chlamydia infection by 50 percent and gonorrhea infection by 78 percent compared to placeboIn April, Evofem released three new data sets for the Phexxi Contraceptive Phase III AMPOWER trialThe AMPOWER study (NCT03243305), a validation one-arm, open label Phase III trial, assessed The effectiveness, safety, and subject satisfaction of Phexxi in about 1,330 healthy women aged 18-35, with a seven-cycle pregnancy rate (21-35 days per cycle)The trial was designed under FDA guidance and advice The latest data released by the this time: (1) Among women who followed instructions to use Phexxi correctly, the effectiveness of contraception was as high as 93.3 percent over seven cycles (extended to 21-45 days per cycle) (2) Women's satisfaction with sex increased after using Phexxi (in the baseline survey, only 17% of women reported that their recent contraceptive practices made their sex life "a little better or better" than before, while after using Phexxi at least one cycle, 45% of women reported that their sex life was "a little better or better"), increased ability to maintain vaginal lubrication during sex (73.9% at baseline and 82.5% on the third follow-up) (3) The reported side effects are rare, the most common adverse reactions are vaginal burning and itching, the rate of reporting continued to decline in each continuous cycle (up to 7 cycles), vaginal burning decreased from 20% to 1.4%, itching decreased from 11.2% to 0.3%, no serious treatment-related adverse events were reported these results support Phexxi's potential to become the first non-hormonal, on-demand, female-controlled prescription birth control vaginal gel, while consolidating Phexxi's position as the most substantial birth control innovation in nearly 20 years and making significant progress for women and their sexual and reproductive health new data not only show that Phexxi was more than 93% effective when instructed to use it, but also highlighted the sexual satisfaction and lubrication factors experienced by women in the AMPOWER trial, which has never been reported in other contraceptive trials original origin: U.S FDA approves Evofem Biosciences' Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Non-Hormonal Prescription Gel for the Case of The original title: this article is sourced from BioValley, download BioValley (http://
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