Does the injectable drug work for the lack of female sexual desire?

03/08/2021 12:11

• Clarín.com

• Good Life

Updated 03/08/2021 12:11

In mid-2019, four years after a pill known as "female Viagra" hit the market, the US drug regulatory authority (the FDA) gave the green light to another drug option to treat lack of sexual desire. female that, unlike its predecessor, was injectable.

Now, an independent analysis of the medical trials that led to its approval

questions its efficacy

.

Bremelanotide is indicated for generalized acquired hypoactive sexual desire disorder (HSDD) in premenopausal women.

The new work, which has just been published in the

Journal of Sex Research

- a peer-reviewed scientific journal - also draws attention to this point, highlighting problems in the validity of TDSH (or HSDD) as diagnosis.

Professor Glen Spielmans of Metropolitan State University in the United States examined the data from the new drug application to the FDA for bremelanotide, the protocol entries

Clinicaltrials.gov

(the page where clinical studies are registered) to the two phase III trials in which the drug was tested against placebo (a substance inherent at the pharmacological level) in

more than 1,200 women

and the article in which the results obtained were published at that time, in the journal

Obstetrics an Gynecology

.

They also performed a meta-analysis of the

efficacy and dropout data

that appear in the FDA application and compared these results with those reported in the journal article.

Spielmans, a professor of psychology, found that 42.1% of trial participants who received bremelanotide

did not complete the study

compared to 20.48% of participants who received placebo, with dropout rates due to adverse events much higher. discharges reported among those who received the drug.

Among those who reached the end of the acute phase of the trials, 87.22% of the participants in the placebo arm wanted to continue treatment in the open phase that followed, compared with 69.97% of those in the bremelanotide group. .

The drug is injected under the skin of the abdomen or thigh

45 minutes before the sexual encounter

.

No more than one dose should be used within 24 hours, nor more than eight per month.

The most common side effects are nausea and vomiting, flushing, injection site reactions, and headache.

The package insert warns that

it should not be used in women with uncontrolled high blood pressure

or in those with known or at high risk of cardiovascular disease.

The article published in 2019 with the results obtained in the trials did not report that the discontinuation induced by adverse events was substantially greater for the group that received bremelanotide compared to those that received placebo, the researcher noted.

Spielmans found more errors in the article: incomplete data reporting,

modified efficacy results and conflicts of interest

, as four of the authors worked for the company that conducted the trials (Palatin Technologies) or for the company that was licensed to market bremelanotide in North America (AMAG Pharmaceuticals), before the license was transferred to Palatin.

"My findings strongly suggest that bremelanotide has

very limited treatment efficacy

, that protocol-specified drug outcomes are mostly not reported in the lead journal article reporting clinical trial results, and that female participants of the trial prefer to take a placebo than bremelanotide, "Spielmans stressed.

However, focusing solely on the problems of clinical trials runs the risk of inadvertently validating TDSH, he warned.

TDSH was

removed in 2013

from the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and was replaced by a combined

condition of female sexual interest / arousal disorder

(FSIAD), which includes reduced sexual desire, lack of response to sexual stimuli and lack of pleasure during sexual activity, which occurs in at least 75% of sexual encounters and causes significant personal distress over a period of at least six months.

"The lack of specification of the duration of symptoms, the questionable validity of the absence of sexual fantasies as a diagnostic criterion, the difficulty in separating individual sexual problems from relational problems, and the failure to take into account cultural influence -including the pressure on women to satisfy the sexual desires of their male partners - in the experience of sexuality makes

TDSH a problematic entity

, "concluded Spielmans.

In August 2015, the FDA had approved flibanserin, which was popularly known as "female Viagra."

A systematic review of the studies leading to its approval found evidence of

fairly modest

treatment efficacy

in terms of relevant rating scale scores and number of monthly satisfactory sexual events.

Now, a new analysis also questions the drug that was believed to be superior, bremelanotide.

"It is essential that we understand how desire works because

no drug will be able to replace the appropriate stimulus

. In general, the lack of desire has to do with the lack of positive stimuli. As long as we continue to medicalize sexuality, we will be increasingly far from one full sexuality ", said in 2019, consulted by the psychologist and sexologist Patricio Gómez Di Leva, who saw only relative utility in the novelty launched in the United States.

For the professional, what is really needed to alleviate the problem of lack of desire is sexual education.

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