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by Alicia Ni Ghrianne, Saturday, November 1, 2014 | Categories: Female Sexual Dysfunction

S1 Biopharma are at it again and about to begin phase 2b trials for their latest offering, a combination of two drugs that are already approved for the treatment of depression, now to be used together as a combined therapy for the treatment of female sexual dysfunction (FSD). Are depression and FSD so inextricably linked and in all cases? How will these antidepressants work for everyone, even women who don’t suffer from depression? Furthermore, much of what I have heard about antidepressants across the board is that they lower libido, so how with this combination work to improve FSD in general?

The two drugs being used in combination are bupropion and trazodone. Since these drugs already have approval from the Food and Drug Administration (FDA), this new combined therapy might be able to gain approval via the fast track route of a New Drug Application (NDA). This is exciting news for the market and for FSD sufferers alike.

Both drugs are exceptions to the rule among the array of anti-depressants that are known to have an effect on libido. In fact, bupropion is proven to increase libido to the levels they were at before depression hit. Trazodone has been shown in a study to increase erectile function in men and lubrication in women when tested as a treatment for sexual dysfunction rather than a treatment for depression. This also explains why one does not have to have depression related FSD in order to gain from this type of treatment.

We know that depression and libido are linked in that a decreased libido is usually associated with this condition. Treating one of these problems often alleviates symptoms of the other. But, FSD is also caused by chronic illnesses, hormone imbalances and deficiencies, abuse of narcotics and alcohol, and is sometimes caused by the use of certain medications, outside of anti-depressants. Studies of both these drugs now show that outside of depression, they might help FSD sufferers overcome their sexual dysfunction and improve the quality of their lives and relationships. 

The medication, to be named Lorexys, can be read about further right here.

by Robert MacKay, Sunday, August 18, 2013 | Categories: Female Sexual Dysfunction

In the past we have discussed a range of treatments aimed at enhancing female libido, such as a nasal sprays and gels to enhance testosterone levels. However, to date there have not been any treatments that have reached the status required to market such a product (other than Intrinsa, which was withdrawn for commercial reasons). That is why we were initially hesitant about a new treatment that was the subject of several recent trials. Yet, it appears to be tackling the issue from a different angle from most other products being investigated to provide a solution for Hypoactive Sexual Desire Disorder. Here we consider what is currently known about the treatment.

The treatment, which goes by the name Lorexys, is a drug that contains bupropion and trazodone. Those active ingredients are often used in antidepressants and work by changing the balance of brain chemicals that play a part in regulating sexual excitation and inhibition. This is in line with the dominating theoretical model, known as Kinsey dual control model. According to that model, brain chemicals such as serotonin, norepinephrine and dopamine inhibit and activate sexual activation in the brain. Therefore, the idea is that an effective treatment is possible if we are able to establish the precise ratio between the active ingredients and the brain chemicals.

Although this model seems straightforward, the process of finding the precise ratios is likely to be arduous. We currently know that several antidepressants, which have taken decades to develop, can cause sexual side effects that include lowered sexual drive. In addition to that, even if the team is certain that they have found the appropriate ratio, dosage will still remain an issue that needs to be investigated before the treatment is marketed. Similarly, we do not yet know anything about the time it takes for the treatment to work and whether there are side effects that may render the treatment unsuitable for some individuals.

On the other hand, there is no denying that the treatment targets an interesting channel (the brain is the body’s largest sexual organ after all) and that if it were to be efficacious then it is likely to have significant implications for the millions of women suffering from FSD.

In addition to this product, Flibanserin is another product in the area of medicine that is currently being considered by the FDA and also targets the brain.

by Robert MacKay, Monday, May 20, 2013 | Categories: Female Sexual Dysfunction

Female sexual dysfunction has always been a controversial topic, with discussions targeting everything from the validity of the concept to the possibility of creating a female “Viagra”. So it came as no surprise to us to see that the marketing of a recently FDA approved drug for dyspareunia (painful sexual intercourse) was met with scepticism from a number of quarters. Given the sharp contrast between the manufacturer’s optimistic prognosis for its applicability and the doomsday reports in some papers, we felt inclined to take a closer look at the issue.

The drug, which goes by the name Osphena, is being marketed following two successful 12-week phase III trials to establish efficacy and a longer trial that examined the safety profile of the active ingredient (ospemifene). The key findings indicated a statistically significant difference between placebo and treatment groups, with the latter having 14% greater alleviation of symptoms. In addition to that, there were reports of more side effects in the treatment groups such as urinary tract infections, increased hot flashes and an increased risk for yeast infection.

One aspect that was criticised was whether the marketing of Opshena misrepresented what dyspareunia is and how many women would benefit from the treatment. Essentially, dyspareunia is painful sexual intercourse that can occur due to a range of medical causes that can be congenital or acquired. These include, but are not restricted to endometriosis, vaginal septa, vulvular vestibules, and vaginismus. Osphena is meant to work by enhancing oestrogen levels that lead to vulvo-vaginal atrophy. However, vulvo-vaginal atrophy is a term used for a process that is not restricted to the genital area but results in the thinning of skin and muscles in general. According to the researchers, Opshena would have the potential to be useful for 64 million women in the US alone. We consider this number to be on the high side by a considerable margin.

Although both sides appear to advocate two extremes, we are glad to see that the findings and marketing of this treatment are not going unnoticed. It is important to understand the rigorous methods required for a treatment to pass a phase III trial. Therefore, even smaller effects may be important and sufficient for a treatment to be taken seriously by the research community. Naturally, no pharmaceutical company would wish to harm an individual in order to increase their profits and we are a bit tired of this dated argument being regurgitated in the media.

What we found interesting was the way dyspareunia was explained. Clearly it is a condition that confuses individuals, and we agree that the manufacturers have inflated the number of women that can be helped. Yet we cannot help to wonder whether the marketing really is a case of misrepresentation. From our experience, we know that many women seek to get an informed opinion from clinicians rather than relying on marketing material. Accordingly, clinicians strive to explain treatments, conditions and risks in enough detail for a patient to feel like they are making an informed decision. This is why we feel that some of the commentary on the marketing of Osphena, needlessly underestimates the intelligence of adult women and ethics of clinicians.

by Robert MacKay, Sunday, November 4, 2012 | Categories: Female Sexual Dysfunction

Researchers in Australia have been given approval to conduct clinical trials regarding a nasal spray that may increase the occurrence of orgasm for women. The spray is known as Tefina. The Australian trials of Tefina are to due start recruiting participants within the coming month, while there are already on-going trials in in Canada and USA.

The spray, which contains a testosterone gel, is fast absorbing and its effects are intended to last for a few hours. If approved, it would be recommended for the times when a woman anticipates sexual activity. Despite containing testosterone, the treatment does not appear to have side effects such as deepening of the voice, increased facial hair or acne.

Anorgasmia, which is a condition where an individual is unable to achieve orgasm despite adequate stimulation, is thought to occur in up to 1 in 3 pre-menopausal women. Anorgasmia is most commonly treated with psychotherapy or sex therapy, but there are no medications that are prescribed with direct relevance to anorgasmia. Therefore, the news of a new treatment is likely to be a cause for optimism among the affected individuals. However, clinical trials tend to be rather lengthy and the results would still need to go through various approval processes. As such, there may be some time before the treatment is out on the market.

Diabetes is already known to cause erectile dysfunction in men but until now there has been no data supporting the theory that the sexual health of women might be affected too. According to a recent study, levels of sexual desire and the amount of sexual activity engaged in by women who are diabetic and those who are not have been revealed to be the same however women who suffer from diabetes report less sexually satisfying events.

The study included women of all ethnicities who were between the ages of 40 and 80 and 2,270 women participated altogether. The group was divided into three and included those with diabetes who took insulin, those who had the disease but who did not take insulin and a control group who were healthy and did not have diabetes.

Out of the entire group, 486 were diabetics including 139 who took insulin and 63.7% of the whole group reported some sexual activity over a 3 month period. The research gleaned that those who were diabetic and treated with insulin were twice as likely to have problems specifically with lubrication and 80% of them had greater difficulty with trying to reach orgasm than healthy women. The study’s authors took into account factors such as race, weight, hormone therapy, age and of course, relationship status.

Knowing that diabetic women are more likely to encounter problems with sexual function means that this risk can be avoided with special diets and exercise and we should be more aware of the effects of this condition on our sexual health. It has also been suggested that symptoms of sexual dysfunction might be brought on by nerve damage caused by elevated levels of blood sugar. A study like this is important in the area of female sexual dysfunction (FSD) considering firstly, that FSD is barely recognised as a condition and also since in the area of treatment, there is next to nothing available.

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