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Novel pill shows promise in treating postpartum depression

One in eight women experience perinatal or postpartum depression, research suggests

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Dr Kristina M. Deligiannidis, professor at the Institute of Behavioral Science at the Feinstein Institutes

A novel investigational postpartum depression pill has shown significant improvement in depressive symptoms in Phase 3 clinical trial.

The Feinstein Institutes for Medical Research at Northwell Health have announced the results from the SKYLARK Study, a phase 3 placebo-controlled clinical trial of an investigational oral, neuroactive steroid zuranolone pill in the treatment of postpartum depression, demonstrating the drug showed rapid, clinically meaningful improvements in depressive symptoms at measured time points.

This would support the potential for the US Food and Drug Administration (FDA) approval of the first oral, at-home, neuroactive steroid therapy to treat PPD.

Approximately one in eight women experience perinatal or postpartum depression (PPD) and current treatment options such as therapy can take months for new mothers to find symptom relief.

The trial, led by Dr Kristina M. Deligiannidis – professor at the Institute of Behavioral Science at the Feinstein Institutes – and published in The American Journal of Psychiatry, has shown a 14-day treatment with zuranolone versus placebo resulted in “significant” improvement in depressive symptoms.

At day 15, the study’s primary outcome measure, with statistically significant improvement in depressive symptoms, reported as early as day three and with improvements sustained at all measured time points through day 45.

Results showed that 57 per cent of the women taking zuranolone versus 38 per cent of women taking placebo experienced a 50 per cent or more improvement in their depressive symptoms at day 15.

At day 45, 61 per cent of the trial participants who received zuranolone compared to 54 per cent of women receiving placebo, experienced a 50 per cent or more improvement in their depressive symptoms.

“Postpartum depression is underrecognised, undertreated and disruptive for those who live with the condition, said” Dr. Deligiannidis, the trial’s principal investigator and lead author of the paper.

“We collaborate with researchers around the world in an effort to develop more rapid and effective therapies for the many women who need support.

“We have been working on neuroactive steroid research in PPD for nearly 15 years. The SKYLARK study follows previous successful clinical trials, and publishing its results is a pinnacle moment in treating postpartum depression.”

Among the 200 enrolled patients and randomised diverse patients screened across international clinical sites, 196 female patients between ages 18 to 45 with postpartum major depressive episodes received the blinded study drug.

Zuranolone (50mg) or placebo was given once daily for 14 days and the patient’s depressive symptoms were evaluated at several defined points in the study for 45 days.

In 2021, Dr Deligiannidis reported the publication of the phase 3 results of the ROBIN Study, which was published in the Journal of the American Medical Association (JAMA) Psychiatry.

The trial demonstrated the improvement in depressive symptoms with zuranolone at 30mg versus placebo in patients with PPD and that zuranolone was generally well tolerated.

Evidence suggests that PPD is partly due to a disruption in the normal interaction between the nervous system’s stress response, ɣ-aminobutyric acid (GABA) signalling, and neuroactive steroids (NAS).

The SKYLARK and ROBIN clinical trials, researchers say, could provide some of the most substantial results for improving depressive symptoms in women with PPD.

Dr Kevin Tracey, president and CEO of the Feinstein Institutes, said: “Dr Deligiannidis is a leader in postpartum depression medical research.

“These clinical trial results are evidence that years of perseverance and dedication lead to significant advances in medicine.”

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Start-up raises US4.2m to address disparities in women’s mental health

LunaJoy Health seeks to address the complex needs of high-risk women

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LunaJoy Health co-founders Sipra Laddha, MD and Shama Rathi, MD

The US telehealth start-up LunaJoy Health has raised US$4.2m in funding to address disparities in women’s mental health.

LunaJoy aims to eliminate inequalities in mental health and “redesign” the way women access care.

The platform, which offers mental health therapy, counselling and medication management, is developing care models that cater to underserved populations, providing care that seeks to address the complex needs of high-risk women.

The funding round, supported by Y Combinator, FoundersX Fund, Goodwater Capital, Magic Fund, VentureSouq, Nurture Ventures and NorthSouth Ventures, is hoped to help the company expand its capabilities and close disparities in maternal health care.

“The support from our investors, coupled with the current focus on maternal health improvements through TMaH funding, sets the stage for the change we need to see so badly across the industry,” said Sipra Laddha, co-founder and CEO of LunaJoy Health.

Mental health is a lifetime pursuit, and we want to design a way to engage and support women with a variety of needs and varying degrees of risk.

“By using technology, we can measure and treat symptoms more effectively, delivering a better service model to meet rising demand and a shortage of therapists in the US.”

This financial and strategic support, Laddha said, will help LunaJoy roll out its “novel” integrated care programme, LunaCare, across select communities in need of maternal mental health.

The investment will also facilitate the integration of advanced technology solutions to enhance care coordination and patient monitoring.

Surbhi Sarna, partner at Y Combinator, said: “LunaJoy Health’s mission to bring a new standard to maternal health care for Medicaid mothers aligns perfectly with our goal of supporting scalable solutions to the world’s most pressing challenges.

“We are proud to back such a vital initiative that promises significant impact.”

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New survey to ‘amplify’ marginalised voices in healthcare decision-making

UK charities enter partnership to address gender gap and advocate for inclusive healthcare policies

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The gynaecological health charity Cysters and Endometriosis UK have announced a partnership to amplify women’s voice in healthcare decision-making.

Despite progress in healthcare data collection, there remains a gap in representing the experiences of marginalised groups, particularly for those impacted by conditions and diseases like endometriosis.

Decision-makers in Parliament and the NHS often rely on data and statistics to inform policy and resource allocation. However, these datasets may not accurately reflect the experiences of marginalised communities.

A recent report from Endometriosis UK that gathered data on the experiences of being diagnosed with endometriosis in the UK found that whilst the ethnicity of respondents who identified as ‘white’ was proportionate to the data collected in the Census 2021, the remaining data was not illustrative of the ethnic diversity of the UK, with 15 per cent of respondents choosing not to respond to the ethnicity question.

To address this gap and advocate for inclusive healthcare policies, Cysters and Endometriosis UK are launching a new survey initiative aimed at amplifying the voices of marginalised groups in healthcare decision-making.

“We know that the current statistics are not inclusive of all communities, particularly marginalised groups,” said Neelam Heera-Shergill, founder of Cysters.

“By encouraging those from marginalised communities to share their experiences through this survey, they will be helping us to advocate for the changes that are needed, backed by evidence from their communities.

“In addition to delving into the diagnosis journey for people of colour and the unique barriers they encounter. We aim for this research and findings to pave the way for additional funded research on all menstrual-related conditions affecting people of colour.”

The survey seeks to gather insights into the experiences of marginalised communities, particularly concerning conditions and diseases like endometriosis.

Participants are encouraged to share their experiences openly and honestly, knowing that their responses will contribute to shaping more inclusive healthcare policies.

Sarah Harris, a researcher at Cysters, said: “We urge everyone to participate in this survey and share it far and wide. Together, we can ensure that all voices are considered in the conversation surrounding healthcare policy and resource allocation.”

The survey is anonymous and takes approximately 15 minutes to complete. To participate, visit Delayed Diagnosis of Endometriosis Among People of Colour in the UK Survey.

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Menstrual care start-up launches period equity initiative across college campuses

The initiative is hoped to facilitate access to period care and educate students on the use of more sustainable products

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Cherie Hoeger, founder and CEO of Saalt

The US menstrual care start-up Saalt has launched a new initiative aimed at addressing period poverty and environmental sustainability.

The Period Equity Initiative aims to reduce 100 million tampons from the environment while combatting period poverty.

Institutions, including Harvard University, Vanderbilt University, Northwestern University, the University of Utah and the University of Nebraska, are already participating in the programme.

One in five female college students in the US have had to decide between buying period products and paying for other basic essentials like food and other bills according to a nationwide survey.

The initiative, a direct response to the demand for more units for student populations, underscores the issue of period poverty, which affects students across America, challenging the misconception that it is solely an “overseas problem”.

Saalt aims to make period care accessible and affordable through the subsidisation of reusable period products, such as cups, discs, and period underwear, to participating universities and their campus affiliates.

The project is hoped to not only facilitate access to period care, but also educate students on the use of more sustainable products, which are designed to be reused rather than discarded.

“Every day we hear from customers about how life-changing Saalt cups are for them,” said Cherie Hoeger, founder and CEO of Saalt.

“Creating period equity and managing the environmental impact created by disposables are pressing matters that demand urgent attention and innovative solutions.

“Through our Period Equity Initiative, we’re taking a proactive approach to tackle these challenges by leveraging our expertise and aligning with universities across America to make a big impact closer to home.”

The Period Equity Initiative, Hoeger added, furthers Saalt’s commitment to making period care more affordable, accessible and sustainable.

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