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Women’s Health

Lupin Signs Promotional Agreement with Exeltis on SOLOSEC® (secnidazole) expanding access for Adult Women Suffering with Bacterial Vaginosis and Adults with Trichomoniasis

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BALTIMORE, January 27, 2022 /PRNewswire/ — Lupine Pharmaceuticals Inc., (Lupin) and Exeltis United States of America Inc. announced an advertising agreement for Exeltis to promote SOLOSEC® along with Exeltis’ existing line of women’s health products, further adding value to OBGYNs and their patients. SOLOSEC® is indicated for the treatment of bacterial vaginosis in adult women (a common vaginal infection) and trichomoniasis in adults (the most common non-viral, curable sexually transmitted infection in the US).1-4

“This partnership will expand the reach of SOLOSEC®, allow more healthcare providers to be aware of the benefits of SOLOSEC®, and improve access for adult women suffering from bacterial vaginosis and adults with trichomoniasis,” he said Vinita Gupta, CEO of Lupin. “We are very pleased about the partnership with Exeltis.Salustiano Perez, Exeltis Chief Executive Officer, added, “Our team is very excited about this partnership. The addition of Solosec fits neatly into our current product portfolio, enhances our business strategy and provides multiple solutions for our customers and their patients.

About Exeltis

Exeltis is a fast-growing division of the integrated health sciences group Insud Pharma. The company holds a leading position in the women’s health segment and is constantly searching for new treatments and devices to improve the health and well-being of women around the world. With a global presence in over 40 countries, Exeltis has a team of more than 4,000 professionals supported by a global manufacturing network. The overarching goal of Exeltis is to support and care for women in all phases of life. It offers a comprehensive portfolio of products to meet women’s fertility, reproductive health, contraception, pregnancy, childbirth and menopause needs. In recent years, Exeltis has also diversified into the areas of central nervous system (CNS), ophthalmology and endocrinology.

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SOLOSEC® (Secnidazole) 2g Oral Granules is the first and only single-dose oral granules approved for the treatment of bacterial vaginosis (BV), a common vaginal infection, in adult women and trichomoniasis, a sexually transmitted infection, in adults.1 – 4 SOLOSEC® is designed to be easy to take and one oral dose contains a full course of treatment.[1]

You can find more information about SOLOSEC® at


SOLOSEC® (Secnidazole) 2g Oral Granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in adult females and trichomoniasis in adults. Because trichomoniasis is a sexually transmitted disease, treat sexual partners of infected patients at the same dose and at the same time to prevent re-infection.


SOLOSEC® is a single dose therapy for oral use. The entire contents of the SOLOSEC® pack should be sprinkled on applesauce, yoghurt or pudding and consumed once within 30 minutes without chewing or crushing the granules. SOLOSEC® is not intended to be dissolved in any liquid. Avoid consuming alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC® and for at least 2 days after completing therapy.


  • SOLOSEC® is contraindicated in patients with known hypersensitivity to secnidazole or other nitroimidazole derivatives.
  • Vulvovaginal candidiasis can develop under SOLOSEC®, which requires treatment with an antifungal agent.
  • The potential risk of carcinogenicity is unknown and has not been studied in patients. Carcinogenicity has been observed in rodents chronically treated with nitroimidazole derivatives structurally related to secnidazole. Chronic use should be avoided.
  • Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC®.
  • The most common adverse reactions observed in clinical trials (incidence ≥ 2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain and vulvovaginal pruritus.

To report SUSPECTED SIDE EFFECTS, contact Lupine Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or the FDA at 1-800-FDA-1088 or

See Important Safety Information.
Please click here for full prescribing information.

Manufactured for and distributed by: Lupine Pharmaceuticals, Inc. Baltimore, Md 21202

Distributed by: Exeltis United States of AmericaInc., Florham Park, New Jersey 07932

About Lupine Pharmaceuticals, Inc.

Lupine Pharmaceuticals, Inc. is the wholly owned subsidiary of US-based Lupine Limited and is the third largest pharmaceutical company in the US by total prescriptions. Collectively, all Lupine-owned companies make up the eighth-largest generic pharmaceutical company in the world by revenue size. Lupine Pharmaceuticals, Inc. is dedicated to providing quality medicines for many treatment areas. The branded pharmaceuticals division of Lupine Pharmaceuticals, Inc. offers products designed to help prevent and treat health problems in women.

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© 2022 Lupine Inc. All rights reserved. SOLOSEC® is a registered trademark of Lupine Inc. and LUPIN® is a registered trademark of Lupine Pharmaceuticals, Inc.

Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995:

This press release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include clinical trial failures, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets, and the ability to maintain patents and other protections of intellectual property. The information contained in this press release is management’s expectations and intentions as of the date. Lupine expressly disclaims any obligation to update the information contained in this press release.

PP-SOL-XXXX, January 2022


[1] Solosec leaflet leaflet

[2] Workowski KA, Bolan GA; CDC. Sexually Transmitted Disease Treatment Guidelines, 2015 [published correction appears in MMWR Recomm Rep. 2015;64(33):924]. MMWR Recomm Rep 2015;64(RR-03):1-137

[3] Onderdonk AB, Delaney ML, Fichorova RN. The human microbiome during bacterial vaginosis. Clin Microbiol Rev. 2016;29(2):223-238.

[4] Koumans EH, Sternberg M, Bruce C, et al. The prevalence of bacterial vaginosis in The United States, 2001-2004; Associations with symptoms, sexual behavior, and reproductive health. Sex Transm Dis. 2007;34(11):864-869.

For more information or queries, please contact –

Schweta Munjal
Vice President & Global Head – Corporate Communications
E-mail: [email protected]

SOURCE Lupine Pharmaceuticals, Inc.

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Women’s Health

Breakthrough in bacterial vaginosis treatment

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Nov 29, 2022 05:07 IS

Boston [US], November 29 (ANI): Over the past ten years, the human microbiome has attracted a lot of attention due to research suggesting that disturbed bacterial communities are to blame for a variety of illnesses, including irritable bowel syndrome, dermatitis, and autoimmune diseases. The majority of research has concentrated on the microbiome found in the human stomach. Still, there is a growing consensus that another frequently understudied bacterial population, that of the vagina, merits equal study.
Bacterial vaginosis (BV), which affects about 30 per cent of reproductive-aged women worldwide and is expected to cost USD 4.8 billion to cure each year, is brought on by disturbances of the vaginal microbiome. Pre-term birth, the second-leading cause of newborn death, and several sexually transmitted infections, including HIV, are both made more likely by BV in pregnant women.
Antibiotics are now used to treat BV, but the condition returns frequently and can result in more serious problems such as pelvic inflammatory disease and even infertility.
Living biotherapeutics are being investigated for the treatment of BV, just as probiotics are now being prescribed to treat gut problems. The human vaginal microbiome differs significantly from those of popular animal models, making it challenging to undertake preclinical experiments. According to studies, lactobacilli bacteria make up more than 70 per cent of the vaginal microbiome in healthy humans, but less than 1 per cent in the vaginal microbiomes of other mammals.
Researchers at the Wyss Institute at Harvard University have created a solution to that problem in the form of a new organ chip that replicates the human vaginal tissue microenvironment including its microbiome in vitro. Composed of the human vaginal epithelium and underlying connective tissue cells, the Vagina Chip replicates many of the physiological features of the vagina and can be inoculated with different strains of bacteria to study their effects on the organ’s health. The chip is described in a new paper published in Microbiome.
Modeling the vaginal microbiome: The Bill and Melinda Gates Foundation provided financing for the creation of the Vagina Chip, which had the goal of developing a biotherapeutic therapy for BV and advancing it into human clinical trials in order to lower the incidence of infant mortality, genital infections, and pregnancy problems. especially in countries with few resources.
“A major stumbling block for that effort was that there were no good preclinical models that could be used to study which therapies can actually treat BV in human tissues. Our team’s project was to create a human Vagina Chip to aid in the development and testing of new therapies for BV,” said co-author Aakanksha Gulati, PhD, a Postdoctoral Researcher at the Wyss Institute.
The scientists seeded the top channel of a polymer chip with human vaginal epithelial cells using the microfluidic Organ Chip technology, which was created at the Wyss Institute and then licensed to Emulate. The other side of the permeable membrane between the top and bottom channels was then supplemented with human uterine fibroblast cells. The 3D design resembled the human vaginal wall in structure.
The Vagina Chip has grown several unique layers of differentiated cells after five days that mirrored those in human vaginal tissue. The Vagina Chip’s gene expression patterns varied in response to the introduction of the female sex hormone estradiol (a kind of oestrogen), showing that it was hormone sensitive–another essential quality for in vitro reproduction of human reproductive organs.

The scientists then moved to study the vaginal microbiome armed with a living replica of the human vagina. They collaborated with Dr Jacques Ravel, PhD, and his group at the University of Maryland School of Medicine, who had developed three different consortia, each of which contained multiple strains of Lactobacillus crispatus, in light of recent research showing that healthy human vaginal microbiomes typically contain multiple strains of Lactobacillus bacteria.
After three days, all three of these consortia successfully colonized the Vagina Chip after being introduced. Lactic acid, which contributes to maintaining the vagina’s low pH and prevents the growth of other microbes, which also started by the consortia.
Beyond helping to maintain an acidic environment, the presence of the L. crispatus bacteria also affected the Vagina Chip’s innate immune responses. Chips with bacterial consortia produced lower levels of several inflammation-causing cytokine molecules than chips without the bacteria, which is consistent with the current theory that these “good” microbes help keep inflammation in check in healthy human vaginas.
Bad bacterial tenants, on a chip: Having created a healthy Vagina Chip with optimal bacterial residents, the team then conducted a new experiment in which they inoculated chips with different species of bacteria that are associated with BV: Gardnerella vaginalis, Prevotella bivia, and Atopobium vaginae.
A consortium of those three “bad” microbes caused the chips’ pH to increase,damaging the vaginal epithelial cells and significantly increasing the production of multiple proinflammatory cytokines – all responses that were similar to what has been observed in human patients with BV.
“It was very striking that the different microbial species produced such opposite effects on the human vaginal cells, and we were able to observe and measure those effects quite easily using our Vagina Chip,” said co-author Abidemi Junaid, PhD, a Research Scientist at the Wyss Institute.
“The success of these studies demonstrate that this model can be used to test different combinations of microbes to help identify the best probiotic treatments for BV and other conditions.”
The team is now using the Vagina Chip to test new and existing treatments for BV to identify effective therapies that can be advanced into clinical trials. They are also working on integrating immune cells into the chip to study how the vaginal microbiome might drive systemic immune system responses.
“There is growing recognition that taking care of women’s health is critical for the health of all humans, but the creation of tools to study human female physiology is lagging,” said senior author Don Ingber, MD, PhD, who is the Wyss Institute’s Foundation Director. “We’re hopeful that this new preclinical model will drive the development of new treatments for BV as well as new insight into female reproductive health.” Ingber is also the Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children’s Hospital and the Hansjorg Wyss Professor of Bioinspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences. (ANI)

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Women’s Health

International Relations Degree: Jobs You Can Pursue with It

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Child marriage is very common menace in Pakistan and is deeply ingrained in traditional, societal, and customary norms. Yet it indicates a severe abuse of the human rights of girls. One in three girls in Pakistan get married before becoming 18 years old (Demographic and Health Survey 2012-13).

A girl’s access to a sound and secure childhood, a good education that can lead to better employability, civic and political empowerment are all violated through early marriages. With 1821 child brides in 2020, Pakistan was placed sixth among nations with the highest number of child brides. Girls lose their childhood and future opportunities when they are married as minors. Girls who marry are less likely to complete their education and are more vulnerable to abuse, marital rape, and health problems. Furthermore, child marriage puts girls at risk for unsafe births, ulceration, STDs, and maybe even death. Also, teenage girls are more likely than women in their 20s to pass away due to difficulties during pregnancy. Firstborn children of women who were 16 years old, 17 years old, and 18-19 years old at the time of birth experienced death rates that were, respectively, 2-4 times, and 1.2-1.5 times higher than those of mothers who were 23 to 25 years old. This is an unfortunate truth, that while the humankind has reached the moon and mars, our women are still dying from unsafe births.

This threat has also been documented in a number of previous articles. However, the latest event of the forced marriage of a young girl from Balochistan, who was just five years old, has shaken me from the core. The girl’s father filed a FIR with the Khuzdar Police Station alleging that his daughter was forced into marriage as a result of regional and tribal beliefs. After the FIR was filed, the Federal Shariah Court Chief Justice took suo-motu notice of the situation and stated that the act appeared to be against both the 1973 Constitution of the Islamic Republic of Pakistan and Islam.

Factors behind forced marriages in Pakistan

There are several factors why early age marriages are prevalent in Pakistan. The majority of these causes include: permissive legislation; a failure to enforce existing laws; the treatment of children as slaves; a primitive feudal class fabric; lack of public awareness of the negative effects of child marriages; widespread poverty; Watta Satta (Weddings between the children of siblings or the exchange of girls in marriage between two households.) underlying trafficking; Concept of Vani (Another harmful tradition is the offering of girls, frequently minors, in marriage or enslavement to a family who has wronged them as payment to settle disputes) and a lack of political will on the part of the government. The inadequacy of birth registration system and lack of responsiveness is a major contributor to forced marriages. The age of the child or children at the time of marriage can be falsified because birth registration for minors, especially girls, is hardly given priority here. Moreover, there is no unified, impartial, or robust child rights associations that might keep an eye on violations of children’s rights, specially female teens.


The Prevention of Anti-Women Practices (Criminal Law Amendment) Act 2011, which has “reinforced protections for women against discrimination and abuse,” was passed in Pakistan in 2012, according to the country’s National UPR report to the HRC. Forced marriages, child marriages, and other social customs that are harmful to women are being made illegal.

The following headings represent how the Committee on the Rights of the Child addressed the problem of child or early marriages in its Final Report and Recommendations (2009): the child’s definition, non-discrimination, respecting the child’s opinions, teenagers’ health, harmful society customs, trafficking and selling

The International Covenant on Civil and Political Rights and the Convention on the Elimination of Discrimination Against Women, whose Article 16 affirms that every woman has the right to get into matrimony “just with her free and unconditional approval,” have both been signed and ratified by Pakistan.

Pakistan has joined the Child Rights Convention, which requires state parties to uphold children’s rights to freedom of thought, conscience, and religion in Article 14.

The Sindh Provisional Assembly unanimously approved the Bill on November 2016 to put an end to forced marriages and conversions. The bill was compellingly prevented by the agitation of the Islamist groups and parties, and was never enacted into law.


First, it seems that nobody in Pakistan, including a lot of women, cares about the precarious status of women. In reality, some educated working women are subjected to so much harassment from men, their families, and society at large that they lack the strength to fight back against their critics. Therefore, the small group of women representatives campaigning for the rights of marginalized women in Pakistan deserve special recognition for their bravery in standing up for and promoting women’s rights despite the fact that doing so would subject them to harassment from males and society.

The government should spend on education particularly in marginalized areas of Pakistan where majority girls have no access to even primary education. Instead of just being a consequence of financial adversity, social conservatism may also contribute to the educational disparity between boys and girls. Long-term policy considerations need to be taken. Lack of maternal education would have a detrimental impact on future generations and is, therefore, just as important as boys’ education because it is believed that mothers’ education plays a significant part in children’s overall development and a complete generation.

Forced marriage victims are also denied access to their most basic yet important right, good education. Here, I want to share a story of a 17 year old advocate fighting child marriages from Swat. Given that it was customary in her household for girls to enter into marriage when they are old enough to fetch water, she was getting married to a taxi driver just at tender age of 11. In an interview, she stated:

“I bravely told my family that if they get me married to that person, I will file a case against them in law. Firstly, they and my community didn’t support me, even denigrated me. But now they do. One human being with conviction can bring the change”

Moreover, police need to be given the capacity to look into the culprits and take appropriate action. I definitely do not mean “Freedom From Law” or “No Accountability” when I talk about empowerment. To ensure that the complaints filed get noticed and are addressed, rigorous policies regarding the institution of police must be devised and put into effect along with increase in the severity of punishments for such activities.

All those engaged in a child marriage, including the parents of the bride and groom as well as the person who solemnises the marriage; the NikahKhwan shall face serious punishment.

The legal age for marriage should be the same for both sexes, which is 18 years. However, the system for registering births needs to be improved. Nadra needs to implement a digital birth registration system that is systematic and reliable.

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Women’s Health

What is women’s health and why is it important?

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At the Norwegian Research Center for Women’s Health, we appreciate the public attention on women’s health over the past weeks here in Norway. I suspect that some of the reason for this debate is that we have different perceptions of what women’s health really is.

Menstrual complaints or life-long health care?

On the labor ward as an obstetrician, I get to share incredible moments with a new family, but I also see women struggling with illness and concerns related to pregnancy, birth and maternity. This part of women’s health, reproductive health, is obviously near to my heart.

For me, as a gynecologist and medical doctor, it is also natural to include menopausal complaints, cervical cancer and endometriosis as a part of women’s health. The fact that women react differently to some medications than men, or that research on how women are treated by the healthcare system is a part of women’s health, can be easier to forget.

I have a plea to politicians and the administration for more earmarked research funds for women’s health (…)

Gender differences in health are also women’s health. These are diseases and disorders that only affect women, affect more women than men, affect especially many women, or have different consequences for women than for men.

A few examples of these inequalities are that women have different signs of a heart attack than men and risk not getting the correct diagnosis, that rheumatic diseases affect more women than men and lack research-based knowledge, or that many older women have osteoporosis that is not optimally treated.

What about women’s health outside of Norway?

Health is often understood in terms of a society’s expectations and resources, and although it perhaps shouldn’t be, I think women’s health in Afghanistan has different issues than women’s health in Norway.

Globally, it is a big problem that women die due to pregnancy and childbirth, or that they do not receive the health care they need because of inequality or lack of access to qualified health care.

In the research project I participate in, we investigate severe bleeding after childbirth. This is potentially life-threatening, but fortunately in Norway women rarely die due to bleeding. Nevertheless, it is important to find out more about such serious complications to childbirth in order to ensure safe births for Norwegian women, but also to contribute to increased knowledge of a complication that may affect all women giving birth all over the world.

Research into women’s health in Norway can therefore also be useful to countries that for various reasons cannot conduct themselves. Research papers are mostly published in a way that makes it possible for everyone to read, and at congresses, we can meet doctors and researchers from all over the world to share the results.

What about women’s health in Norway today, and what are the knowledge gaps?

As a woman in Norway in 2022, I actually believe I am quite well off. I am lucky to live in a society with a focus on equality between men and women, and with a public healthcare system available to all.

Nevertheless, I know that certain women’s diseases have a lower priority by both health personnel and in research. The Norwegian Women’s Public Health Association has demonstrated how endometriosis is a disease with a knowledge gap, which is not prioritized enough by health care personnel. Another, and often shameful condition with lack of attention, is chronic genital pain, and these examples are far from alone.

Just before the turn of the millennium, a report on women’s health in Norway came out (NOU 1999:13, The report that there was a lack of knowledge, both about specific women’s diseases and about connections between health and living conditions. It also demonstrated that there was already important knowledge about women’s health and living conditions that was not taken into account in health care policy decisions or in the health care system.

Lack of research on girls and older women

In Norway, the time has now come for a new evaluation of women’s health, and a new report will be drawn up by the women‘s Health Committee, a public committee on women’s health and health from a gender perspective.

I hope that the updated collection of knowledge will reach our decision makers, and that the content is taken into account in other ways, so that the committee’s work contributes to change and improvement of women’s health in Norway.

With regard to further research into women’s health, a report was recently published by the Norwegian Institute of Public Health. The report shows that there is a lack of research on girls as children and adolescents, as well as older women.

It also revealed that there is a lack of systematic reviews on certain conditions, for example prolapse of the vaginal wall. We also need more knowledge on how traditional treatments affect women in diseases such as COPD, skin cancer and lipoedema.

What do we research at the Norwegian Research Center for Women’s Health?

I am so proud of all my colleagues that advocate women’s health at the hospital, and in the field of research!

In our shared office is obstetrician and senior researcher Katariina Laine. Among other things, she has researched, and contributed to the reduction of perineal injuries after childbirth.

Also in the office is dermatologist Kristin Skullerud. Her research project is testing medications against the painful vulva disease genital erosive lichen planus. Her supervisor and dermatologist Anne Lise Helgesen has also created the website, which contributes to increased knowledge about vulvar complaints, a part of women’s health previously neglected.

I hope you have learned a little more about women’s health, and understand my passion for women’s health care and research.

I have a plea to politicians and the administration for more earmarked research funds for women’s health. And to the same politicians and to the health care facilities, a demand for action to implement the treatment that the research demonstrates is missing.

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