hypoactive sexual desire disorder

Low sex drive? Kisspeptin hormone injection may help, researchers say

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  • Hypoactive sexual desire disorder (HSDD) affects about 30% of women and 15% of men.
  • Researchers from Imperial College London in the United Kingdom say the hormone kisspeptin could be used to treat HSDD.
  • Scientists found that kisspeptin helps improve sexual brain processing, boosting sexual responses in both men and women with low sex drive.

Hypoactive sexual desire disorder (HSDD) — where a person has an extremely low sex drive that causes them distress — affects about 30% of women and 15% of menTrusted Source.

Treatment options for HSDD include psychotherapy, sex therapy, lifestyle changes, medications, and hormonal therapies.

Adding to these choices, researchers from Imperial College London in the United Kingdom say the hormone kisspeptinTrusted Source could be used to treat HSDD by boosting their sexual response.

Two studies examining the effect of kisspeptin on HSDD were recently published in the journal JAMA Network Open — one focused on womenTrusted Source and the other on menTrusted Source.

What is HSDD? 

HSDD research suggests that it tends to affect more womenTrusted Source than men. The condition may come on at any time and can either be a long-term issue or only occur in certain situations.

Those at a higher risk for HSDD include those with:

Symptoms of HSDD include:

  • little to no sexual desire
  • little to no sexual thoughts
  • no interest in masturbation
  • inability to be aroused
  • no response to sexual signals
  • inability to orgasm
  • loss of erectile or ejaculatory function in men.

A person can have a low sex drive but not have HSDD. When a person has HSDD, it causes them distress.

Previous research finds people with HSDD have a lower quality of life, lower general happiness, and experience more negative emotions.

What is kisspeptin? 

Kisspeptin is a naturally occurring hormone found in the hypothalamus region of the brain. It helps stimulate the release of other reproductive hormones in the body.

Past research shows that kisspeptin plays an important role in the female reproductive systemTrusted Source, and it also helps regulate a person’s emotions and mood.

According to Dr. Alexander Comninos, honorary senior lecturer in the Department of Metabolism, Digestion and Reproduction at Imperial College London, consultant endocrinologist at Imperial College Healthcare NHS Trust, and co-senior author of the studies, about 10 years ago scientists realized that there was a lot of kisspeptin in areas of the brain related to sexual behavior.

“We tested this in healthy men and found that there was a boosting of sexual brain pathways,” he explained to Medical News Today. “Hence, we wanted to see if we could translate this to determine if giving kisspeptin could help individuals distressed about their low sexual desire.”

Dr. Comninos added there is currently a need for new treatment options for HSDD.

“Currently available treatments in [the] U.S, for women have limited effectiveness and carry significant side effects such as nausea, drowsiness, and interactions with alcohol,” he detailed.

“In men, there are no licensed treatments, as Viagra is predominantly a mechanical agent acting on the penis. Hence there is a significant unmet need to discover new safe and effective treatments for distressing low sexual desire,” Dr. Comninos explained.

Treating HSDD with kisspeptin

For these studies, researchers conducted two clinical trials — one with 32 premenopausal women and another with 32 men, all with an HSDD diagnosis. Participants underwent MRI brain scans, as well as blood and behavioral tests.

At the conclusion of the studies, researchers found men and women who received the treatment with kisspeptin experienced increased sexual brain processing, resulting in positive effects on their sexual behavior, compared to participants who had not received the hormone.

“Kisspeptin receptors are in the reward areas which control sexual desire in the brain,” Prof. Waljit Dhillo, an NIHR senior investigator in the Department of Metabolism, Digestion and Reproduction at Imperial College London. consultant endocrinologist at Imperial College Healthcare NHS Trust, and co-senior author of the studies told MNT.

“When men and women are looking at erotic images, their reward areas in the brain which control sexual arousal are more stimulated,” he explained.

“Our results suggest that giving kisspeptin can restore and even boost the brain balance related to sexual behavior,” Dr. Comninos added.

“It appears to suppress areas related to overthinking that are often overactive in HSDD and thereby release the brake on sexual arousal so they become more aroused. It was great to see that both women and men responded well to kisspeptin and in men, there was even a pro-erectile effect.”

– Dr. Alexander Comninos

When might the treatment be available? 

For the next step in this research, Dr. Dhillo said that “[f]urther trials will be needed in a large group of patients taking it at home to see how effective it will be.”

Dr. Comninos agreed and said if further studies and development go well, we might see kisspeptin-based treatments for distressing low sexual desire in five to 10 years.

“Crucially, kisspeptin appears to be very well tolerated — we did not see any side effects in these studies,” he continued. “Interestingly, there also appear to be other beneficial effects of giving kisspeptin. We have performed early work suggesting that kisspeptin may also have beneficial effects on bones and the liver.”

Potential especially to help men

MNT also spoke with Dr. Barbara Chubak, associate professor of urology at the Icahn School of Medicine at Mount Sinai, about kisspeptin as a treatment option for HSDD.

She said she was pleased by the possibility of having another medication with which to potentially help men struggling with low sexual desire.

“HSDD is a problem that affects men and women alike, and one that can be present in the setting of normal sex hormone levels,” Dr. Chubak explained. “And HSDD — I suspect because of gender stereotyping — is the rare exception to the rule in medicine, where we actually have more treatments available for women than we do for men.”

“Currently, the only FDA-approved medications for HSDDTrusted Source are approved for pre-menopausal women; they are used off-label in men, but there is scant research data to support that use,” she continued.

“The use of testosterone to increase male sexual interest is more established, but typically unhelpful when the patient has normal testosterone level at baseline. We also often use erectile dysfunction medications (e.g. sildenafilTrusted Source) to compensate for the manifestation of low libido as [erectile dysfunction], but this can also be unhelpful, as these medications rely on the presence of sexual interest to prompt genital arousal response,” Dr. Chubak went on to say.

As for what she would like to see next in this research, she said scientists need to evaluate whether kisspeptin is a safe and effective treatment for HSDD.

“Additional important considerations for any new medication are ease of use — ideally in a form that can be self-administered by the patient themselves, rather than the intravenous bolus used in the study — and durability of effect,” she continued. “I look forward to seeing research along these lines in the future.”

‘Viagra for Women’ Wins FDA Panel Support | Medpage Today

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Mixed but strong support for so-called ‘Viagra for women’

An FDA advisory committee voted 18-6 Thursday to recommend approval for flibanserin, a drug meant to treat sexual dysfunction and loss of sexual desire in women.

The “yes” vote at the joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee included a requirement for “certain risk management options beyond labeling,” such as provider certification and postmarketing studies.

Flibanserin, a product of Sprout Pharmaceuticals, is proposed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The suggested dose is a 100-mg tablet taken in the evening before bed.

Sprout Pharmaceuticals describes HSDD on its website as “a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty.” It clarifies that diagnosis is not related to “a medical, substance-related, psychiatric (e.g., depression), or other sexual condition.”

Walid Gellad MD, MPH, of the University of Pittsburgh, voted to recommend approval of the drug, but tempered his support saying he saw its benefits as “modest” or “less than modest.” “But I think that puts it in good company with other approved drugs.”

Gellad supported a risk evaluation and management strategy (REMS) and also supported provider certification.

Michele Orza, ScD, the panel’s acting consumer representative and a senior adviser at the Patient-Centered Outcomes Research Institute, in Washington, voted against approving the drug. Orza called the treatment effect “minimal” or “marginal at best” and said she worried that as the FDA considers future products it will find that the standard is “too low and problematic.”

If You Drink, Don’t

The majority of the committee recommended a REMS strategy as well as other postmarketing studies specifically focused on use of the drug with alcohol, long-term studies to assess the drugs effects on fertility, harm to a fetus, cancer risks, and accidental injury.

In his opening statement, Hylton Joffe, MD, director of the Division of Bone, Reproductive and Urologic Products (DBRUP) acknowledged that there is an unmet need for a drug to treat HSDD. He agreed that the sponsor had met its primary endpoints in three phase III clinical trials.

Missing the Endpoint

All three trials showed “statistically significant improvement” in the number of orgasms and other satisfying sexual events (SSE) and a reduction in sex-related distress in participants taking flibanserin compared with control participants, according to FDA reviewers. The sponsor drug showed a median placebo-corrected increase of approximately 0.5-1.0 SSEs per month, from the median baseline of two to three events per month.

Neither of the first two trials demonstrated a statistically significant improvement in the secondary endpoint of sexual desire, when rated in a daily electronic diary. However, both showed a statistically significant improvement when such desire was rated using the Female Sexual Function Index (FSFI). A third trial, which used the FSFI as a co-primary endpoint for sexual desire, found the endpoint statistically significant:

“From a mean baseline of about 1.8-1.9 on the FSFI desire score, flibanserin resulted in a placebo-corrected mean increase of 0.3-0.4 (the FSFI desire score range is 1.2-6.0).”

“From a mean baseline of 3.2-3.4 on the distress score, flibanserin resulted in a placebo-corrected mean improvement of 0.3-0.4 (on a scale of 0-4).”

But the sponsor and FDA are “not in full agreement that the FSFI is optimized for assessing sexual desire,” the staff review noted. At the meeting, Ashley Slagle, MS, PhD, endpoints reviewer for FDA, said the FSFI “specifically includes multi-barrel instruction, making it unclear what components might be driving any score change, so … if one component [like fantasizing] improves but other components might not improve; it’s unclear whether a change in one single element represents meaningful change.”

Safety Concerns

Joffe also highlighted the drug’s major safety concerns: hypotension, syncope, and central nervous depression and its “sizable placebo effect.”

Some of the panel’s safety concerns centered on alcohol use while on flibanserin. The committee noted the data on alcohol use was particularly unhelpful as Sprout’s pivotal alcohol study included only two women.

Speakers for the meeting’s public hearing portion were divided on the drugs’ approval.

Lisa Larkin, MD, a women’s health internist who practices in Cincinnati, told the committee “day after day” she sees patients distressed by their sexual health concerns.

“I take real issue with those who suggest that low libido in women is always the result of relationship or situational issues, anxiety, depression, something that can always be addressed in psychotherapy or that pharma has somehow created this disorder as a niche for a drug.” She urged those who ascribe to those view to spend a day in her practice.

Sidney Wolfe, MD, founder of Public Citizen’s Health Research Group, in Washington, D.C., questioned whether there was any new information on the drug now compared with 5 years ago, “when an FDA advisory committee voted 11-0 that the benefits did not outweigh the risks … I have concerns about exclusions in the trials and [the drug’s] minimal level of effectiveness.”

Wolfe noted that hypotension and syncope are not trivial and can result in serious, irreversible, or life-threatening injuries. “If there were clear evidence of a clinically meaningful benefit, accompanied by manageable risk, approval might be appropriate, but neither of these two is the case. I would urge the FDA to reject the drug; it isn’t ready for prime time.”