Drug for treating sexual disorder in women not effective despite FDA approval, report finds

ST. PAUL, Minn. — For people who lack the ability to feel sexual desire, the issue can put a strain on their mental health and could even affect their partner. Although medications try to reenergize a low libido, a new study finds one medication for women isn’t doing the job. A researcher from Metropolitan State University says bremelanotide does not appear to be effective at treating hypoactive sexual desire disorder (HSDD) in women.

The findings reveal some female participants actually preferred taking a placebo rather than the HSDD medication. Professor Glen Spielmans examined the clinical trials which led to the drug’s approval by the U.S. Food and Drug Administration. This included data from bremelanotide’s FDA New Drug Application, the clinicaltrials.gov results for two 24-week Phase III trials, and the journal article that reported on both trials. Prof. Spielmans also analyzed the effectiveness and dropout rates coming from the FDA application.

Despite its approval for use, the results point to bremelanotide having “very limited effectiveness” in actually treating women with a low libido. Researchers generally characterize HSDD as having low sexual desire which causes the patient distress. People dealing with HSDD have an absence of sexual fantasies and thoughts and a lack of desire to have sex. The main component of the disorder is that it’s causing a problem for the person experiencing it. For some, a low libido will not affect their mental state or even their partner.

Problems range from diagnosis to treating HSDD

The study notes that hypoactive sexual desire disorder was actually removed from the American Diagnostic and Statistical Manual of Mental Disorders in 2013.

Spielmans’ review finds over 42 percent of trial participants taking bremelanotide did not complete the clinical study. In comparison, just over 20 percent of participants taking a placebo dropped out of trials. Patients taking bremelanotide also reported adverse side-effects more often than other participants.

Among the test groups reaching the end of the trial phase, more than 87 percent taking a placebo wanted to continue treatments. Just under 70 percent taking bremelanotide said the same.

Despite these results, the article detailing the trials did not report the higher dropout rates from adverse medical events due to bremelanotide. It also did not report that participants preferred taking a placebo over the HSDD drug.

“My findings strongly suggest that bremelanotide has very limited treatment efficacy, that the protocol-specified outcomes of bremelanotide are mostly unreported in the main journal article reporting the clinical trial outcomes, and that trial participants would rather take a placebo than bremelanotide,” Prof. Spielmans says in a media release.

Conflicts of interests discovered?

The new report also reveals the journal article (Kingsberg et al., published in Obstetrics and Gynecology) had incomplete data and changed efficacy outcomes. In addition, four of the authors of the report on bremelanotide either worked for the company conducting the trials or the company licensed to market the medication.

Aside from issues with the reporting of these tests, Spielmans says the main issue with HSDD is the difficulty in verifying a woman’s symptoms.

“The lack of specifying symptom duration, questionable validity for the lack of sexual fantasies as a diagnostic criterion, difficulty in disentangling individual sexual problems from relational problems, and the failure to consider cultural influence – including the pressure on women to satisfy the sexual desires of their male partners – in the experience of sexuality all render HSDD as a problematic entity,” the study author concludes.

The study appears in the Journal of Sex Research.

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