HealthIBSA UK introduces Hyaluxelle®, a non-hormonal injectable for menopausal vulvovaginal symptoms

IBSA UK introduces Hyaluxelle®, a non-hormonal injectable for menopausal vulvovaginal symptoms

An advanced hyaluronic acid-based treatment developed to address the sexual and genital symptoms associated with GSM.

IBSA UK, the UK arm of Swiss pharmaceutical company IBSA, has announced the launch of Hyaluxelle®, a non-hormonal hyaluronic acid injectable indicated for adult women experiencing atrophic symptoms of the vulvar vestibule. These symptoms include vaginal dryness, burning, itching and pain at the vaginal opening during intercourse (dyspareunia)[1].

The launch of Hyaluxelle® offers clinicians an additional treatment option for women whose symptoms continue despite first-line approaches, as well as for those who are unable or unwilling to use hormonal therapies for the genital and sexual symptoms of GSM. The treatment is intended to support clearer, more inclusive patient care pathways.

Genitourinary Syndrome of Menopause (GSM) is a long-term condition driven by oestrogen deficiency, affecting the genital, urinary and sexual systems[2]. Symptoms are progressive and persistent, and typically do not resolve without treatment[2]. It is estimated that at least 50% of post-menopausal women are affected[3], yet many do not seek medical advice, often assuming symptoms are an inevitable part of ageing[4].

Vulvovaginal atrophy is among the most common and distressing manifestations of GSM. It results from ongoing trophic changes in vaginal and vulval tissues associated with low oestrogen levels, leading to symptoms such as dryness, discomfort, altered vaginal pH and pain during intercourse. These changes can significantly affect confidence, relationships and overall quality of life[2–5].

Joanna, a 59-year-old woman living with severe GSM symptoms, describes the personal impact of delayed diagnosis. “I lived for years with pain, UTIs, cystitis and a loss of sensation, but every visit to my GP, even a female GP, was treated as a bladder issue. Nobody suggested it might be linked to the menopause or joined the dots, and none of the treatments I was given helped. Without the right information or support, I became desperate for answers.”

She added: “The symptoms affected everything, what I wore, how I exercised, how I slept, but the hardest part was the impact on intimacy with my husband. I withdrew from our relationship because I was scared sex would hurt, and the loss of closeness was devastating, and I no longer felt like myself. Women deserve clear explanations and real options when their symptoms are not getting better.”

Hyaluxelle® is a clinically focused, non-hormonal injectable developed using IBSA’s patented NAHYCO® Hybrid Technology. The formulation combines high- and low-molecular-weight hyaluronic acid to form hybrid cooperative complexes that enhance injectability and tissue compatibility.

This design allows for a lower-viscosity injection at the highest hyaluronic acid concentration currently available in the UK, supporting tissue hydration, elasticity, firmness and favourable conditions for tissue regeneration[6].

Treatment with Hyaluxelle® involves deep intradermal injections into the vulvar vestibule over two sessions, administered one month apart, followed by clinical reassessment[1]. The viscoelastic and moisturising properties of the formulation help restore hydration and promote tissue repair through collagen and elastin production[5].

Clinical studies show that Hyaluxelle® is effective in improving multiple vulvovaginal symptoms associated with GSM[5,7], including reductions in vaginal discomfort and pain during intercourse[7].

Evidence also demonstrates improvements in aspects of sexual function and positive trends in certain health-related quality-of-life measures[7]. Histological findings indicate increased epithelial thickness, improved tissue regeneration and reduced inflammatory infiltration following treatment[5]. Hyaluxelle® has been shown to be well tolerated, with no major complications reported in clinical studies[5,8].

References
1. HYALUXELLE®. Instructions for Use.
2. Christmas M, et al. Clin Obstet Gynecol. 2024;67(1):101-14.
3. Benini V, et al. Medicina (Kaunas). 2022;58(6):770.
4. Nasreen SZA, et al. American Journal of Internal Medicine. 2019;7(6):154-62.
5. Garavaglia E, et al. Med Devices (Auckl). 2020;13:399-410.
6. Humzah D, et al. Int J Mol Sci. 2024;25(6):3216.
7. Mohammed GF, et al. Health Sci Rep. 2023;6(3):e870.
8. Garavaglia E, et al. Aesthetic Medicine. 2023;9(1):35-42.
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