Something that surprises lot of people, female Viagra isn’t approved in UK, and that’s not an oversight. It is a deliberate regulatory decision with layers of medical, political and commercial reasoning. Men had access to phosphodiesterase-5 inhibitors like sildenafil since 1990s but women dealing with sexual dysfunction have been left with few options in UK, none that carry official approval for female sexual desire disorders.
This article breaks down why that gap exists, what the science actually says and what women in UK can and can’t access today.
What is Female Viagra and Why Has This Name Stuck?
Female Viagra is a colloquial term used to refer a small number of medicines best known of which are flibanserin (marketed as Addyi) and bremelanotide (Vyleesi). Sildenafil which increases blood flow to genital. Flibanserin acts on neurotransmitters in brain.
Bremelanotide is an injectable drug act on melanocortin receptors. So, these are not female versions of same mechanism. These different drugs address distinct biological puzzles. This term is medically misleading, and this confusion has complicated public and regulatory discussions regarding these products.
Why Has Female Viagra Isn’t Approved In UK?
MHRA has not granted marketing authorization for flibanserin or bremelanotide in UK. EMA also rejected flibanserin in 2019, stating that the balance of benefits and risks was unfavorable. Main reasons by regulatory bodies cited are:
- Clinical Benefit: Flibanserin increase number of satisfying sexual encounters from 0.5-1, this is too narrow to justify approval.
- Safety Concerns: Flibanserin carry warning in US for hypotension and syncope when combined with alcohol or certain CYP3A4 inhibitors. For a lifestyle adjacent condition, this risk benefit calculus weighed heavily.
- Female Sexual Dysfunction: Erectile dysfunction is mostly attributed to vascular causes and can be measured. Hypoactive Sexual Desire Disorder in women involve psychological, relational, hormonal and contextual factors.
- UK/EMA Application Absence: Manufacturers have not submitted applications to Medicines and Healthcare products Regulatory Agency following UK’s withdrawal from EU. Without an active application no approval is pursued.
There is also criticism including from some physicians and patient advocates that regulators apply a stricter lens to drugs targeting female sexual health than they historically did to male equivalents.
US Approval Story and What it Means For UK?
Flibanserin approved by FDA in 2015 after two rejections following advocacy campaigns under banner of “Even the Score,” which argued that gender bias was driving the rejections. FDA approved it with a Risk Evaluation and Mitigation Strategy requiring no alcohol agreement from patients. That US approval did not translate UK or EU approval.
Regulatory bodies are independent and they evaluate same data differently. The EMA’s 2019 rejection noted insufficient evidence of clinical benefit and disproportionate risks. When UK left EU, it inherited EMA decisions made before Brexit meaning flibanserin’s non-approval was carried forward. For anyone looking to Buy Viagra Online (the male kind) through UK pharmacies, that’s now straightforward as sildenafil has been available OTC since 2018.
What is Cialis for Women?
Tadalafil (Cialis) is another PDE5 inhibitor like sildenafil is prescribed to treat ED and benign prostatic hyperplasia in men. Cialis for Females has been studied for women sexual dysfunction with arousal difficulties or those on antidepressants that suppress sexual response.
The results have been mixed. Some studies showed improvement in arousal and lubrication for women with sexual arousal disorder particularly in postmenopausal women or those with diabetes. But no regulatory body has approved tadalafil for women and it remains an off-label consideration in clinical practice.
Some UK specialists may prescribe it off-label in specific circumstances but it is not a sanctioned treatment for female sexual dysfunction in this country.
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Understanding Female Sexual Arousal Disorder
Female Sexual Arousal Disorder is characterized by a persistent or recurrent inability to maintain sufficient sexual excitement which may be expressed as lack of subjective excitement, lack of genital lubrication/swelling or both causing personal distress. FSAD is distinguished from HSDD (hypoactive sexual desire disorder), though they frequently co-occur. Contributing factor include:
- Menopause
- Postpartum Changes
- Thyroid Issues
- Anxiety
- Depression
- Trauma
Treatment in UK focus on sex therapy, relationship counselling and hormone therapy. There’s no approved pharmacological agent specifically for FSAD which is approved female sexual dysfunction drugs feel so significant to patients and clinicians.
Note On Wider Discussions Surrounding Sexual Health
Female ejaculation and female masturbation aspects of women’s sexuality that have been under researched classified as pathological conditions or simply ignored by mainstream medicine. This same cultural neglect has directly contributed to the slow pace of approval for drugs intended to treat sexual dysfunction in women.
Research into female sexual physiology has accelerated since 1990s but significant gaps remain. Regulatory caution regarding medicines for female sexual dysfunction may reflect genuine concern about scarcity of available evidence, but it also fits into a broader context of chronic underfunding of women’s health and lack of prioritization of women in clinical research.
Will it Change? Regulatory Outlook
There are currently no applications pending with Medicines and Healthcare products Regulatory Agency for drugs ‘flibanserin’ or ‘bremelanotide’. Pharmaceutical companies producing these drugs have not approval in UK. Stronger data from clinical trials showing tangible benefits, patient advocacy campaigns gaining significant traction in UK could change this picture.
NICE updating its guidelines to recommend a specific drug regimen would also open the door. Female Viagra isn’t approved in most of world US remains a notable exception. UK position is consistent with international norms outside North America.
Conclusion
Female Viagra isn’t approved in UK it reflects regulatory caution genuine gaps in clinical evidence and historical pattern of women sexual health receiving less research attention and less commercial investment than men. Available to women here is testosterone therapy, psychosexual support and lifestyle interventions which are genuinely helpful but it is not same as having a pharmacological option that directly targets desire or arousal disorders.
FAQs – Frequently Asked Questions
1. Can We Buy Flibanserin in UK?
No, flibanserin cannot legally sold or prescribed as a licensed medicine in UK.
2. Is Any Treatment for Low Sexual Desire Women in UK?
Yes, National Institute for Health and Care Excellence recommend testosterone therapy for treatment of low sexual desire in menopausal women and sex therapy is also recommended.
3. Why Flibanserin Approved in US But Not in UK?
FDA approved the drug ‘flibanserin’ in 2015 under significant pressure from its supporters. EMA and MHRA evaluated same trial data and concluded benefit didn’t outweigh safety concerns particularly interaction with alcohol causing hypotension.
4. Can Cialis (Tadalafil) Work for Women?
Tadalafil may improve arousal and lubrication in women particularly those suffering from sexual dysfunction caused by vascular problem.
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