Dyspareunia

Daré Bioscience Reports Full Year 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, March 28, 2024
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SAN DIEGO, March 28, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the year ended December 31, 2023 and provided a company update.

Key Points: 
  • In addition, we are excited about the increased attention that women’s health has received more broadly,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • In December 2023, Daré announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1.
  • Financial Highlights for the Year Ended December 31, 2023 and 2024 Projections
    Cash and cash equivalents: $10.5 million at December 31, 2023.
  • Daré will host a conference call and live webcast today, March 28, 2024, at 4:30 p.m. Eastern Time to review financial results for the year ended December 31, 2023 and to provide a company update.

EDAP Announces FDA Breakthrough Device Designation for Focal One® in the Treatment of Deep Infiltrating Rectal Endometriosis

Retrieved on: 
Monday, March 4, 2024
TMS, Woman, Diarrhea, FDA, Quality of life, Tenesmus, Food, DIE, Endometriosis, Quality, Constipation, Dyspareunia, Rectum, Prostate, Fatigue, EDAP, Patient, Diagnosis, MRI, Weakness, Pharmaceutical industry

“This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives.

Key Points: 
  • “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives.
  • The Focal One system being granted a Breakthrough Device designation underscores the significance of this innovative development for DIE patients.
  • In January 2022, EDAP reported positive results from the Phase 2 Endo-HIFU-1R study (N=60) evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis, and this data was included in EDAP’s submission in consideration for receiving Breakthrough Device designation from the FDA.
  • In February 2024, EDAP announced the completion of enrollment in a Phase 3 study evaluating Focal One HIFU therapy for the treatment of deep infiltrating rectal endometriosis.

Mycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd's Commercial Launch of VIVJOA® (Oteseconazole) Capsules for the Treatment of Severe Vulvovaginal Candidiasis (VVC) in China

Retrieved on: 
Wednesday, February 7, 2024
Partnership, Oteseconazole, Vaginal discharge, Red, Candidiasis, Capsule, Irritation, CYP, Fluconazole, Yeast, Patient, National Medical Products Administration, Azole, Enzyme, FDA, Candida albicans, Excipient, Dyspareunia, Vaginal yeast infection, Hypersensitivity, Combustion, Fissure, CYP51, Woman, Pharmaceutical industry

DURHAM, N.C., Feb. 7, 2024 /PRNewswire/ -- Mycovia Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical company, today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui") has commercially launched VIVJOA® (oteseconazole) in China, making available an innovative oral azole antifungal indicated for the treatment of severe vulvovaginal candidiasis (VVC). VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.

Key Points: 
  • VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.
  • "The disease burden in China is significant, and access to VIVJOA provides health care providers and women suffering with severe VVC a new treatment option."
  • Vulvovaginal candidiasis is an exceedingly common mucosal infection usually caused by Candida albicans but can occasionally be caused by other Candida species or yeasts.
  • In April 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole) Capsules as the first medication for Recurrent Vulvovaginal Candidiasis (RVVC, or chronic yeast infection).

EDAP Announces Completion of Enrollment in Phase 3 Study Evaluating Focal One HIFU Therapy for the Treatment of Deep Infiltrating Rectal Endometriosis

Retrieved on: 
Thursday, February 1, 2024
Quality of life, Weakness, EDAP, MRI, Patient, Endometriosis, Tenesmus, TMS, Rectum, Diarrhea, Physician, Dyspareunia, Constipation, Quality, Fatigue, Woman, Pharmaceutical industry

LYON, France, February 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis.

Key Points: 
  • LYON, France, February 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis.
  • The ongoing Phase 3 study ( NCT05755958 ) is a comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels in 60 patients.
  • In January 2022, EDAP reported positive results from the Phase 2 Endo-HIFU-1R study (N=60) evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis.
  • The study also evaluated the effect of HIFU treatment on endometriosis symptoms and Quality of Life (QoL).

Medicines360 and DKT WomanCare Announce Strategic Partnership to Expand Access to the Hormonal IUD Avibela™

Retrieved on: 
Wednesday, January 31, 2024
SAN, Nausea, Clinical trial, Perforation, Birth, Fibroid, Internal bleeding, Liver failure, Infection, Artery, Pelvic pain, DKT International, Jaundice, Anticoagulant, Blood pressure, Ovarian cyst, Woman, Acne, Organization, Partnership, Endometritis, Angioedema, History, Abscess, Contraindication, DKT, Peritonitis, Rash, Coagulopathy, Dyspareunia, Inflammatory cytokine, Adhesion, Vomiting, Bacterial vaginosis, Headache, Bowel obstruction, IUS, Uterus, STI, Breast cancer, Miscarriage, Patient, Fertility, Sepsis, Marketing, Risk, Stroke, Organ, Streptococcus, Hormone-sensitive cancer, Liver tumor, Cyst, Intrauterine device, GAS, Pregnancy, PID, Social marketing, Vaginitis, Migraine, Myocardial infarction, Health, Brain, Birth control

"As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.

Key Points: 
  • "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.
  • “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception.
  • As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies.
  • Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market.

Knight Therapeutics Announces Product Launch for IMVEXXY® in Canada

Retrieved on: 
Thursday, January 4, 2024
Quality of life, Woman, GUD, Estradiol, Pain, Menopause, Dry, Dyspareunia, Therapy, Vaginal discharge, VVA, Ageing, Common, Health Canada, TSX, Patient, Birth control

MONTREAL, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of IMVEXXY® in Canada.

Key Points: 
  • MONTREAL, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of IMVEXXY® in Canada.
  • “We are very excited about the launch of IMVEXXY®, a new treatment option for postmenopausal women in Canada.
  • Knight and TherapeuticsMD signed a license agreement in July 2018 pursuant to which TherapeuticsMD granted Knight the exclusive Canadian commercialization rights to IMVEXXY® (estradiol vaginal inserts).
  • Under the terms of the license agreement related to IMVEXXY® in Canada, Knight will pay TherapeuticsMD sales milestone fees and royalties based upon certain aggregate annual sales of IMVEXXY® in Canada.

Daré Bioscience Announces FDA Clearance of Investigational New Drug (IND) Application for DARE-VVA1, a Novel Intravaginal Formulation of Tamoxifen for Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy Associated with Menopause

Retrieved on: 
Thursday, December 7, 2023
Personal lubricant, Quality of life, Food, Woman, IND, Breast cancer, HR, FDA, Prevalence, Menopause, Syndrome, Dyspareunia, SAN, Inflammation, VVA, History, Tamoxifen, Pharmaceutical industry

With the IND clearance from the FDA, Daré can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1.

Key Points: 
  • With the IND clearance from the FDA, Daré can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1.
  • VVA is an inflammation and thinning of the vaginal epithelium due to chronic hypo-estrogenism, which is the reduction in levels of circulating estrogen.
  • Typical symptoms include vaginal dryness, itching, burning, and painful intercourse (dyspareunia), adversely impacting quality of life.
  • Products containing estrogen are commonly used to treat VVA but some women cannot or choose not to use these products, including those with a history of hormone-receptor positive (HR+) breast cancer.

Vulva health conditions: it's time to shatter the silence

Retrieved on: 
Tuesday, September 5, 2023
Dyspareunia, Shame, Vagina, Hotlines, Male, Self-harm, Surgeon, Lifeline, Vaginismus, Awareness, Suicide, Dermatitis, Anatomy, Terminologia Anatomica, National Suicide Prevention Week, Taboo, Cancer, Woman, Anger, Research, Blog, Language, Psoriasis, Vulvodynia, British Association of Dermatologists, Pain, Thought, Itch, Man, Radiation, Patient, Association, Clitoris, Fracture, Menopause, Dermatology, Miscarriage, Pleasure, Mouse, Health, Vulva, Recurrence, GP, Female, Breast cancer, Disease, Dietary supplement, Dentistry, Birth control, Nursing

I didn’t know I had a vulva until I was diagnosed with lichen sclerosus and stage three vulval cancer.

Key Points: 
  • I didn’t know I had a vulva until I was diagnosed with lichen sclerosus and stage three vulval cancer.
  • She spoke of her anger at how, despite numerous doctor appointments, her cancer was not spotted until it was at an advanced stage.
  • Baumhauer had had symptoms since the age of five, feeling burning pain “like razor blades” when going to the toilet.
  • Despite undergoing 58 rounds of radiotherapy in 2016- 2017, Baumhauer experienced a recurrence in 2023 and had to have further surgery.

A disturbing silence

    • There are accounts of women experiencing dyspareunia (pain during sex) in ancient Egyptian papyri.
    • Yet today there is still an oppressive silence around the vulva and vulval disease.
    • This article is part of Women’s Health Matters, a series about the health and wellbeing of women and girls around the world.
    • So young women and those who menstruate grow up thinking gynaecological pain is just something to be accepted, even expected.
    • Instead, we receive the message that we shouldn’t be surprised when we experience pain or itching, but we also shouldn’t talk about it.

Breaking the silence

    • In the 1970s and 1980s, women began to break the silence and share their breast cancer experiences with the public.
    • The disease claims tens of thousands of lives a year, but a silence surrounded it meaning many missed the early signs.
    • And recently singer Meghan Trainor shared her experience of vaginismus, a condition causing the pelvic muscles to tense up painfully during sex.
    • Visual, literary and performing arts can be powerful tools for breaking down stigma.

Women's sexual desire often goes undiscussed – yet it's one of their most common health concerns

Retrieved on: 
Friday, September 1, 2023
Desire, Dyspareunia, Education, Life, Pregnancy, Virginity, Orgasm, Menopause, Woman, Infertility, Emotion, Libido, Perineum, Mindfulness, Hormone, Pain, Body image, Man, Arousal, Shame, Human, Blue balls, Personal lubricant, Blame, Pleasure, Miscarriage, Research, Health, Mental health, Fatigue, Birth control, Nursing, Female

Despite desire (also known as libido or sex drive) being the most common sexual health concern for women, most women aren’t really taught about it growing up.

Key Points: 
  • Despite desire (also known as libido or sex drive) being the most common sexual health concern for women, most women aren’t really taught about it growing up.
  • Discrepancies in sexual desire and satisfaction are often reported as key reasons for relationship difficulties.
  • This article is part of Women’s Health Matters, a series about the health and wellbeing of women and girls around the world.

Desire is constantly changing

    • Desire is also a multifaceted response, which can either follow or occur at the same time as pleasure or arousal.
    • Sexual desire can also be affected by many environmental factors, which helps explain why it may wane during periods of stress or in longer term relationships.
    • Even factors such as gender roles and norms are thought to cause low sexual desire for women in heterosexual relationships.

Certain life transitions can have a major effect

    • Pregnancy, the post-partum period, perimenopause and menopause are all significant transitional periods in women’s lives that can also have a major impact on sexual desire.
    • For example, body changes that may happen during these transitional periods can affect body image and self-esteem, which in turn affects desire.
    • Importantly, these life transitions also affect other areas of our lives – and may lead to stress, fatigue, changes in relationship roles and less time for intimacy.

Desire can be cultivated

    • Recent psychosocial approaches to addressing low sexual desire emphasise the importance of balancing intimacy and eroticism, which is a focus on sensuality and pleasure over arousal and orgasm.
    • Research indicates that, while intimacy is essential in healthy partnered sexuality, eroticism helps increase desire by promoting mystery and sexual excitement.
    • Sexual desire is not a problem to be solved – but a skill to be learned and cultivated throughout life.

The Feminine Well-Being: Quanta System’s Laser Improves Intimate Health and Quality of Life for Women With Various Pathologies

Retrieved on: 
Wednesday, August 30, 2023
Health, Medical Devices, Consumer, Women, Surgery, Health Technology, Biotechnology, Quanta, Dyspareunia, Vagina, Atrophic vaginitis, Vaginal discharge, Elastin, Pathology, Quality of life, Multimedia, Research, Cell, Fibroblast, Embarrassment, Regenerative medicine, Urinary tract infection, Lichen, Gold standard, Lubricant, Dermatology, GSM, Personal lubricant, Urination, Menopause, Collagen, Vulva, EMPOWER, Urinary incontinence, Birth control, Nursing, Woman

Genitourinary syndrome of menopause (GSM), previously known as atrophic vaginitis or vulvovaginal atrophy, affects more than half of postmenopausal women.

Key Points: 
  • Genitourinary syndrome of menopause (GSM), previously known as atrophic vaginitis or vulvovaginal atrophy, affects more than half of postmenopausal women.
  • However, most would be willing to try a product for symptom relief and would appreciate information and treatment suggestions from their healthcare professional.
  • "This means that we, gynecologists or healthcare professionals, must actively inquire about these types of problems and refer women to specialists who can help them.
  • "Laser treatments are definitely non-painful, fast, and efficient procedures, and they are real solutions to return to a normal and better life."