WASHINGTON: US health authorities approved on Tuesday, after having denied twice, marketing a treatment against disorders of sexual desire in women, with a warning about the potentially harmful effects this drug.
The Food and Drug Administration (FDA) also points out that this treatment, flibanserin, which will be marketed under the brand Addyi by the laboratory Sprout Pharmaceuticals, may be obtained with a prescription.
The media have called this pink pill “Female Viagra” even if it’s not in the same way that the blue pills sold since 1998 by Pfizer to treat erectile dysfunction in men.
Originally developed by the German laboratory Boehringer Ingelheim as part of research on the treatment of depression, flibanserin is sexual stimulation in the brain while Viagra promotes blood flow to the genitals. This treatment, which must be taken daily and belongs to the class of selective inhibitors of serotonin reuptake (SSRIs, SSRI or English), which includes antidepressants like Prozac.
The FDA refused in 2010 a first application for a marketing authorization, an advisory committee has concluded that the benefits of treatment were lower than the risks associated with it is made.
Boehringer Ingelheim then sold the laboratory Sprout, which is not publicly traded. The latter performed new tests and a new application submitted to the FDA, which has yet issued a refusal in 2013.
This FDA decision led to campaign against Sprout, with the support of feminist organizations, accusing them of sexism US health authorities since they had approved Viagra. The FDA members have vigorously denied the charges.
RISK SYNCOPE
Flibanserin is for premenopausal women why sexual desire disorder causes psychological suffering.
“This is the most important step for the sexual health of women since the advent of the contraceptive pill”, welcomed the National Consumers League in a statement. “This validates (and) legitimate women as an important sexuality health aspect.”
Critics of this medicine believe however that the libido gain shown by clinical trials is too small compared to the risks, such as decreased blood pressure, or fainting, especially when drinking during taking the treatment.
The consumer organization Public Citizen and the predicted Addyi will be withdrawn from the market in the coming years due to the “serious dangers to women with low benefits.” “Unfortunately, we have not heard the last of this drug,” thinks that association.
The announcement of the FDA green light for commercialization of flibanserin has boosted about 30% share of Palatin Technologies in transactions after the close on the New York Stock Exchange.
This laboratory is currently developing a competing treatment, bremelanotide, including clinical trials entered their final phase. According to Palatin Technologies, this treatment works differently from Addyi seeking to activate certain brain connections and it takes only when needed, and not every day.
