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FDA approves application for investigational hormone-free contraceptive

Ovaprene could become the first FDA-approved monthly, self-administered, hormone-free contraceptive product



FDA's IDE application allows investigational devices to be used in clinical studies to collect safety and effectiveness data

The Food & Drug Administration has approved an Investigational Device Exemption (IDE) application to allow the US company Daré to conduct an efficacy study of its hormone-free contraceptive.

Daré Bioscience, a clinical-stage biopharmaceutical company aiming to advance innovative products for women’s health, has designed Ovaprene to prevent pregnancy by releasing a locally acting, non-hormonal agent which impedes sperm motility, and physically blocking sperm from entering the cervical canal with a knitted polymer barrier.

The IDE approval reflects that the FDA determined the company provided sufficient data to support the initiation and conduct of the study.

The IDE submission included the results of the postcoital test (PCT) clinical study of Ovaprene, in which Ovaprene prevented all sperm from entering the cervical canal across all women and all cycles evaluated. PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness.

“We are driven to bring forward innovative options that support women’s health and wellness, and we are motivated to accelerate the development and introduction of differentiated product candidates, like Ovaprene, which is both hormone-free and designed to be conveniently kept in place vaginally continuously over the weeks between menstruation,” said Sabrina Martucci Johnson, president & CEO of Daré Bioscience.

“When it comes to contraception, many of the top-selling brands in the category are delivering both convenience and efficacy, suggesting that women and healthcare providers have a preference for contraceptive methods that are effective, that don’t need to be administered every day, and that don’t require action at the time of intercourse.”

In order for the planned study to serve as the primary clinical support for a future marketing approval or clearance, the FDA provided additional study design considerations with the IDE approval letter.

“The FDA communication confirms our alignment on a number of key aspects of the clinical study, including the adequacy of a 12-month (13 menstrual cycles) duration,” explained Johnson.

“The additional study design considerations provided by the FDA are considered by the administration to be recommendations that do not need to be addressed in order for us to initiate and conduct this study. However, implementing the guidance that we received will further position this pivotal study to collect safety and effectiveness data that will support the submission of a Premarket Approval (PMA) application.

“We look forward to working with our collaborators at the NIH and at Bayer to review and implement the recommendations and we are targeting mid-year 2023 study recruitment initiation.”

The single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive device along with its safety and usability. If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the US and other countries.

In January 2020, Daré and Bayer announced an exclusive licensing agreement for US commercial rights to Ovaprene. Under the agreement, Daré received an upfront payment and access to Bayer’s extensive clinical and market capabilities while retaining control over Ovaprene’s development and regulatory approval process.

Bayer received the right to obtain exclusive rights to commercialise the product in the US following completion of the clinical trial being undertaken by Daré.

If Ovaprene is approved by the FDA, it could be the first monthly non-hormonal contraceptive product for women and a first-in-category option for women seeking a hormone-free, self-administered and monthly birth control method.


Start-up launches London Underground campaign to break down period stigma

The two-week campaign seeks to challenge societal taboos surrounding menstrual health



The Irish women’s health start-up Riley has launched an ad campaign on the London Underground to “take the fear out of periods”.

Riley, an eco-friendly period product subscription service, aims to take action against period poverty and democratise access to period products.

The company seeks to encourage the introduction of menstrual health policies and foster a workplace where discussions around periods are normalised.

Its two-week London Underground campaign, which coincides with the opening of its first office in London, is hoped to help destigmatise periods and normalise conversations around menstrual health.

“The idea behind this campaign comes from the fact that free period care in the office is often seen as an employee perk or a ‘nice to have’, when it should actually be an essential offering in every office,” Meaghan Droney, eCommerce manager at Riley, told Femtech World.

“Our aim with this campaign is to flip those current mindsets and get people to change their attitudes towards period care in the workplace.

“With 79 per cent of menstruators feeling unsupported in relation to their periods at work, this oversight is clearly fundamentally unfair and it’s time for change.

“We’re encouraging any and all businesses to get in touch with us so we can support them in introducing menstrual policies and free period care in their workplace to empower all employees, no matter their gender, to thrive and feel valued at work.”

Research by the Chartered Institute of Personnel and Development (CIPD) shows that only 12 per cent of UK companies provide support for menstruation and menstrual health, despite 85 per cent of women experiencing stress or anxiety when managing their period at work.

Data suggests that half of the women who take absence because of their menstrual cycle feel unable to tell their manager, underscoring the deep-rooted stigma around periods.

Fiona Parfrey, co-founder of Riley, said: “Access to safe and high-quality sustainable period care products not only demonstrates a commitment to employee welfare but also fosters a culture of empathy, equality, and respect, ultimately contributing to a more engaged and empowered workforce.

“Menstrual policies and free period care are a fundamental necessity for every individual in the workplace. It’s about ensuring that employees have the resources they need to maintain their wellbeing and productivity without interruption.”

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Singapore-based fertility centre sets up grant for couples struggling to conceive

This grant aims to support eligible Singaporean couples facing financial and family planning challenges



A Singapore-based fertility centre is to set up a grant to support couples struggling to conceive.

Virtus Fertility Centre Singapore (VFCS) announced that it would set up a grant to support aspiring parents on their IVF journey.

The initial grant is set for at $50,000 SGD and, depending on the take-up rate over the next 12 fiscal months, VFCS plans to increase the pool to benefit more couples in the subsequent years.

The grant will cover the main costs associated with IVF treatments and procedures, including embryo retrieval and transfer, laboratory services and embryo prep. It will also be applicable to fresh and frozen egg transfers.

As grant recipients, their samples will similarly be given a radio frequency identification (RFID) tag, a service VFCS provides for all its patients. It locks the patient’s identity with the respective sample. The RFID identifies gametes—eggs, sperms, or embryos—at every stage of the IVF treatment.

According to VFCS, the grant will also include access to counselling services and wellness resources.

“I’ve witnessed firsthand the emotional toll and occasional frustration that infertility can take on individuals and couples, especially for some who are still young and healthy,” said Dr Roland Chieng, medical director at VFCS.

“The common deterrent of going for fertility treatment is always associated with the cost, more so in a private care setting where their only source of funds is through Medisave.

“By alleviating their financial concerns, we hope ReadyBaby Fertility Grant empowers patients to approach their IVF journey, focusing on their clinical needs and working towards a healthy pregnancy and less on financials.

“With access to the necessary treatments and support, patients can embark on their path to parenthood with renewed confidence, knowing they have the clinical resources and guidance they need to navigate this journey,” he added.

Tim Kwan, VFCS’s managing director, said: “We believe every couple deserves the opportunity to experience the profound joy of parenthood.

“With the ReadyBaby Fertility Grant, we aim to support aspiring couples on their IVF journey and help them bring new life into the world.”

To be eligible for the grant, applicants must be married Singaporean couples diagnosed with medical infertility by a fertility specialist and first-time parents who have not tried IVF before.

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Canadian insurer launches partnership to support women’s health

Members of the Canadian insurer Medavie Blue Cross will have access to a dedicated women’s health platform



Angela Johnson, co-founder and CEO of sanoLiving

The Canadian insurer Medavie Blue Cross (MBC) has partnered with the virtual health platform sanoLiving to support women on their menopause journey.

Currently, more than 10 million Canadian women are navigating menopause, often with little support and misinformation about treatments.

With sanoMidLife, sanoLiving’s online menopause platform, Medavie Blue Cross members will have access to a national women’s health platform tailored to provide care and services for women going through the menopause.

The service includes personalised assessments, access to clinicians, treatments, educational content, peer support and AI assistance.

“Many women lack support for their menopause transition due to the misunderstandings of what is ‘normal’ and misinformation about treatments,” said Angela Johnson, co-founder and CEO of sanoLiving.

“Women are seeking solutions that allow them to thrive during midlife. We are thrilled about our alliance with Medavie Blue Cross, and our shared commitment to providing access to care that empowers women.”

Anita Swamy, senior vice president operations at Medavie Blue Cross, added: “We’ve heard first-hand from our members about the need for more menopause-related services.

“Our partnership with sanoLiving creates an innovative way to increase access to care for our members as we continue to focus on the support women need to navigate their benefits and provide forward-thinking options to support their health.”

Studies report one in 10 women exit the workforce due to unmanaged symptoms. Early onset of menopause and symptoms before age 45 can elevate the risk of health issues like heart disease, diabetes, dementia and osteoporosis.

With this new service, Medavie Blue Cross and sanoLiving are aiming to open up the conversation around menopause, reduce stigma and work towards giving women the access to the care they need.

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