Freya Pharma Solutions Announces Advice from the FDA on its US Clinical Development Program of LybridoTM for the treatment of Female Sexual Interest/Arousal Disorder

 

Freya Pharma Solutions, a pharmaceutical company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), announced today that the United States (US) Food and Drug Administration (FDA) has informed Freya that they will provide a written response by 4 June on the request for advice on the US Clinical Development Program of Lybrido^TM for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD).

After obtaining advice from the European Medicines Agency (EMA) in September 2022, Freya Pharma Solutions is currently preparing the confirmatory ALETTA trial as part of the clinical development program of Lybrido^TM in Europe. As a next step Freya has designed a clinical development program for the US in close collaboration with its Scientific Advisory Board consisting of leading experts in the field of FSD from the US and Europe, to prepare for a Marketing Authorization Application (MAA) of Lybrido^TM in the US. On Freya’s request for advice, the FDA has now planned to provide a written response by 4 June 2023, where Freya’s objective is to reach an agreement with the agency regarding the clinical development program of Lybrido^TM in the US.

Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions said:

"The announced response from the FDA on our clinical development program for Lybrido^TM in the US marks a major next step in our plans to bring Lybrido^TM to the market, and to make a contribution to the lives of many women suffering from FSD.  It can be concluded that there is a high unmet need among women suffering from FSD for effective and safe treatments, which are currently not available in Europe and are very limited in the US, and that Lybrido^TM is expected to address such a need. The ALETTA confirmatory clinical trial is planned to start soon in Europe, and we hope that with the advice from the FDA we can also soon start preparing clinical trials in the US. The company is highly confident that it is well on track with the clinical development of Lybrido^TM as a treatment for women suffering from sexual disorders and the related distress which often negatively interferes with their quality of life and their relationships.”

Just six months of frequent exercise improves men’s sperm quality

Sedentary men who start exercising between three and five times per week improve their sperm counts and other measures of sperm quality in just a few months, according to a new study published today in Reproduction. The researchers also found that men exercising moderately and continuously improved their sperm quality more than those following popular intensive exercise programs like HIIT.

1 in 3 couples struggle to conceive due to poor semen quality. The only treatment available for couples unable to conceive naturally is IVF, but using poor quality sperm may increase the risk of miscarriage, birth defects and the development of childhood cancer.

Current advice for men seeking to improve their chances of conceiving include combining healthy eating with regular exercise while giving up smoking and reducing the intake of alcohol. However, the link between exercise and sperm quality is not definitely proven. Some studies have even shown that strenuous exercise, such as long-distance running and endurance cycling, may actually have a negative impact on sperm quality.

In this study, researchers from the Urmia University in Iran set out to investigate whether the time men spend exercising and the intensity at which they work out have an impact on sperm quality. The researchers investigated 261 healthy men aged between 25 and 40 years old. Men who followed a regular exercise program or did more than 25 minutes of exercise more than 3 days per week were excluded from participating.

The researchers assigned each participant to one of four groups: moderate intensity continuous training (MICT), high intensity continuous training (HICT), high intensity interval training (HIIT), or a control group that did no exercise.

MICT and HICT exercises consisted of running on a treadmill for half an hour and one hour for 3-4 days per week respectively. HIIT consisted of short one-minute bursts of sprinting on a treadmill, followed by a one minute recovery period, repeating between ten to fifteen times. These routines were followed during a 24-week period.

Semen samples were taken before, during and after the different exercise regimens to assess the men’s semen volume, sperm count, morphology, motility, levels of inflammatory markers and their response to oxidative stress.

The researchers found that men in all exercise groups had improved sperm quality across all measures when compared to the samples from the control group.

After completing the 24-week program, the MICT exercise group showed the biggest improvements in sperm quality, and also maintained these benefits for longer. Compared to the control group, those following MICT had:

·         8.3% more semen volume

·         12.4% higher sperm motility

·         17.1% improved sperm cell shape/morphology

·         14.1% more concentrated sperm

·         and 21.8% more sperm cells on average

However, the benefits to sperm count, shape and concentration started to drop back towards pre-training levels after a week of stopping the exercise program, and sperm motility 30 days after stopping.

“Our results show that doing exercise can be a simple, cheap and effective strategy for improving sperm quality in sedentary men,” said Behzad Hajizadeh Maleki, lead author of the study. “However, it’s important to acknowledge that the reason some men can’t have children isn’t just based on their sperm count. Male infertility problems can be complex and changing lifestyles might not solve these cases easily.”

The authors noted that while losing weight in general is likely to have contributed to improving sperm quality, MICT may have had the most profound impact on sperm quality because it reduces the gonad’s exposure to inflammatory agents and oxidative stress.

The researchers’ next steps are to investigate whether the training-induced changes in sperm quality will affect their fertilizing potential.

  

Study highlights women’s distress at lack of interest in sex

A qualitative study from a team of researchers at Monash University (Melbourne) has sought to understand the personal impact of loss of sexual interest on women and the expectations of women seeking treatment for their problem. This is the first study to consider the real-life situation of women seeking treatment at a clinic; previous studies have actively sought out women with sexual problems, which may change the expectations and experiences of the patients. This work is published in the December edition of the peer-reviewed journal Climacteric*.

Loss of sexual interest is the most commonly reported sexual problem amongst women. Although researchers have identified that loss of interest in sex can be very concerning for women, there has been little understanding as to what motivates women to seek help for this problem. There is also little known about women’s expectations of treatment for female sexual dysfunction.

The team interviewed 17 women who had been referred to the Cabrini Medical Centre (Melbourne, Australia) for specialist assessment and possible treatment.  In depth face-to-face interviews took place prior to the medical consultation, in which women were asked to talk about their sexual worries and the reasons for attending the clinic. Four major themes emerged during the course of the interviews.

1 Personal psychological distress: these feelings manifested themselves in low self-esteem, feelings of guilt, sadness, worthlessness, inadequacy, frustration, disappointment and embarrassment:

·         ‘I think a feeling of guilt from my point of view and from my husband probably a feeling of not being attractive to me. A feeling of not being adequate maybe’ (Olivia, aged 43).

·         Older participants also reported psychological distress. Justine, aged 70, stated: ‘I just do not feel inclined to have sex. I want to approach my husband, to be physical. There is nothing there. I just don’t feel anything at all. You know it has been for a few years now and I just don’t think that’s normal because I am not that old. This is disappointing that I do not like to be touched. ’

2: Concern about the adverse effect of lack of sexual interest on the relationship with their sexual partner Although most women appreciated their partner ’s support, they were concerned about the negative effects of their sexual problems on intimacy and cited this as a driving factor for seeking medical help:

·         Stella, aged 47 described: ‘Physically I don’t really feel like I need to be sexually active. I do get concerned about the future and whether it is going to affect the relationship with my husband. ’

·         Emma, aged 51 stated: ‘It’s not like our marriage is in trouble because of it, but it is definitely something that we both would like to enjoy and my husband would like more of. It is important for any marriage and relationship. You still need to have that regardless of how long we’re together whether it’s 10, 20, 30 years. I guess it’s always the thought of hearing other people having regular sex and you say “what’s wrong with me?”. ’

 

Theme 3: A belief in a relationship between lack of sexual interest and ‘hormone deficiency ’

Many women spoke of a ‘lack of hormones in their bodies ’:

·         Clara, aged 62 said ‘… But you are not dead yet, you are still functioning, your body still functions, but when we are menopausal our levels go down and of course you don’t feel like sex.

 

Theme 4: An expectation of treatment outcomes, which included positive physical and sexual changes

Many women viewed hormonal treatment as a ‘magic bullet’. Postmenopausal women were eager to receive menopausal hormone therapy and testosterone. Women hoped these would benefit them physically and sexually, that they would have more energy, look younger and fitter and be healthier. They anticipated increased spontaneous sex drive, arousal, orgasm and an enjoyable sex life:

·         Adele, aged 53, said ‘ … I want some energy. I feel I am a young, fit, healthy, happy woman. I am blessed, but I just would like to not feel like I’m 80 years old sometimes. I don’t recover from exercise anymore. I am quite exhausted and I fall asleep all the time. I like to feel more energetic, to not be asleep at 9 o’ clock at night every night. That would be nice and probably to feel more spontaneous’.

 

3-4 months after treatment, 10 of the women were again interviewed. Treatment with vaginal estrogen alone or MHT (Menopausal Hormone Therapy) alleviated the symptoms of concern and was associated with improved sexual wellbeing. Four women who were treated with testosterone therapy, in addition to MHT, all reported a benefit of treatment.

 

·         Justine, 70 years, said: ‘Before I did not like to be touched and that is improved after treatment. I feel ok. I am feeling better in myself.

·         Alice, a breast cancer survivor, reported only partial symptom relief with vaginal estrogen therapy said: ‘ … there is (still) some pain, but intercourse is not impossible’

 

Research leader, Professor Susan Davis said.

 

“It is important to understand that this is a qualitative study, not a clinical trial. Studies such as this help us get to the core of what women who want treatment are experiencing and inform us about what we should be looking at, and which questions to ask in a clinical trial.  A huge number of women are affected by sexual problems globally, but we don’t really know much about how it makes women feel and what they expect of treatment. The important feature about this study is that the participants didn’t respond to an ad to be in the study. These were simply women attending a practice seeking help for their problem.  This study shows that the women who are seeking help for sexual interest/arousal problems are profoundly affected by their problem.  Most of the women we interviewed were deeply concerned about intimacy and about the effect of lack of sexual interest on their relationship.  Often the distress many women feel because of this just isn’t understood”.

Commenting, Professor Camil Castelo-Branco (Chair of the Council of Affiliated Menopause Societies**, and Professor of Obstetrics and Gynecology at Barcelona University) said:

 

“This qualitative study examines the personal impact of loss of sexual interest on women, and also what were the expectations of those women who sought treatment for their sexual problems. But data from this qualitative study may give additional clues for health care providers.   If we could reproduce this work on a larger sample, we may be able to assign these patients into groups which would allow us to design specific therapies for sexual problems and better management of this condition: in other words, to give a more personalized management of sexual problems.

Health care providers should keep in mind that the women in this study have broken through considerable personal barriers in talking about their problems. Intimacy is difficult to talk about, and these women deserve our respect. We owe it to them, and to other women (and indeed men) suffering as a result of this problem, to help improve their quality of life”.