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Attention grabbing

Pharmaceutical companies are making advances in the treatment of female sexual dysfunction, a condition that remains poorly defined and is often under-treated.

pipelineThe US National Health and Social Life survey has revealed that sexual dysfunction affects 43 per cent of women compared with 31 per cent of men, generating increased public interest in female sexual dysfunction (FSD).

Developments with sildenafil have also led to increased interest in the disease, despite the fact that it appears to be less effective in women than in men. Nonetheless, FSD remains poorly defined and under-treated.

A number of formulations of testosterone have yielded promising results for the treatment of FSD. Watson Laboratories in partnership with Procter & Gamble has developed a transdermal testosterone patch, Intrinsa, - set to be one of the first treatments on the market specifically for FSD.

The patch uses Watson's transdermal TheraDerm MTX system to deliver small amounts of testosterone. Results from the Intimate SM 1 trial in women with hypoactive sexual disorder and surgically-induced menopause found that Intrinsa (300µg/day) increased the total number of satisfying sexual events by 74 per cent. In addition, sexual activity and desire increased with Intrinsa over placebo in patients in the Intimate SM 2 trial.

Intrinsa is still awaiting approval from the Food and Drug Administration over concerns that testosterone dosages higher than normal levels may increase the risk of adverse events. However, the treatment appears to have an acceptable tolerability profile and was associated with a low overall incidence of adverse events in both phase III Intimate trials.

Cellergy Pharmaceuticals has developed a promising transdermal testosterone gel, Tostrelle. Results from a phase II study in postmenopausal women with FSD found that the gel (0.5 per cent administered as a metered dose) was associated with a 65 per cent increase, from baseline, in the total number of satisfying sexual events.

Furthermore, BioSante Pharmaceutical's topical testosterone gel, LibiGel, has been proven to increase the number of satisfying sexual events by 238 per cent in a trial involving surgically-induced menopausal women, with low sexual desire and activity, receiving dosages of 150µg/day.

Alternative mechanism
Vivus and Acrux are exploring potential treatments through the development of a transdermal spray, testosterone MDTS (Metered-Dose Transdermal System). The spray delivers a set dosage of testosterone using Acrux' Across skin penetration enhancers also found in sunscreens.

Results from a phase IIb trial found that after 16 weeks of treatment, the number of satisfactory sexual events more than doubled in pre-menopausal women with decreased libido who were receiving the second highest dosage of the transdermal spray, testosterone MDTS.

A phase III trial of Vivus' topical alprostadil, Alista, a vasodilator that increases blood flow to female genitalia, has also produced promising results. Alista 100µg and 400µg increased genital vasocongestion by 77 per cent and sexual arousal by 97 per cent.

NexMed has also developed a topical formulation of alprostadil, Femprox, which is undergoing phase III trials in women with FSD. Femprox has already been launched for the treatment of erectile dysfunction in men as Alprox-TD.

In a phase II trial involving 98 premenopausal women with FSD, alprostadil cream at 500µg, 1000µg and 1500µg/day dose was associated with mean arousal success rates of 43 per cent, 61 per cent and 54 per cent, respectively.

Something for everyone
King Pharmaceuticals and partner, Palatin Technologies, has also developed a potential intranasal treatment for female and male sexual dysfunction using a melanocortin receptor agonist, PT 141. A phase II pilot study in women found that PT 141 20mg significantly increased levels of sexual desire, genital arousal, and satisfaction, compared with placebo.

PT 141 can be administered 30 minutes prior to intercourse, which is less than the time required for conventional oral erectile dysfunction therapies. In addition, PT 141 is unlikely to be contraindicated with nitrate co-administration.

The Author
Ngairita McMillan, Adis International

2nd September 2008

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