On August 18, 2015, the FDA approved a drug called Addyi to treat sexual dysfunction in females. Viagra was approved by the FDA in 1998, so it has taken almost 20 years to create and approve a drug to treat sexual dysfunction in women. Addyi is a treatment for premenopausal women with a low sexual desire. Hypoactive Sexual Desire Disorder (HSDD) is acquired in a women who has never has problems with sexual desire. HSDD does not occur from pre-existing medical or psychiatric conditions, relationship problems, or the use of other drugs.
Side effects of Addyi are nausea, sleepiness, dry mouth, dizziness, and insomnia. Risks involved with taking Addyi are hypotension and loss of consciousness. Alcohol interferes with the breakdown of Addyi so if the patient consumes alcohol with Addyi, those risks are greatly increased. The drug is highly regulated and prescribers need to be REMS(risk evaluation and mitigation strategy) certified before administering to patients. They also need to strictly review the importance of not drinking alcohol with the patients. The FDA is requiring Sprouts Pharmaceuticals, the company to manufacture Addyi, to perform three studies to further know the effects of drinking alcohol with the drug.
Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist. It is still unknown exactly how the drug increases sexual desire. The patient is supposed to take one pill every single day. About 10% of women who participated in a study testing Addyi reported increased sexual desire. There is still more research to be done on this drug and long term effects on the patient, but at least sexual dysfunction in women is being addressed.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm
Isabella, this is awesome! Sexual dysfunction has obviously been researched extensively in males: viagra and other nitrate medications are widely available to men, but sexual dysfunction in females has mostly been neglected. Many people might believe that women cannot experience dysfunction in their sex lives, but sexual dysfunction does indeed exist and can be detrimental to romantic relationships! This is the first time I am hearing of Addyi and it appears to be a rather unique medication. I find it interesting that it has been approved by the FDA without the actual biochemical mechanism behind the increases in sexual desire being known. There are many wide-ranging side effects that must be researched further, but it really is remarkable that there is finally a form of female viagra on the market!
ReplyDeleteThis is intriguing, and I had never even heard about this condition prior to reading your post. While this is a monumental breakthrough for women with hypoactive sexual desire disorder (HSDD), it does carry with it some mixed reactions from women and health care professionals. There were some concerns regarding the evidence presented about Addyi’s safety and effectiveness. Although there are stipulations involved with the drug, reflecting the safety concerns, criticism has still accompanied it. One health care professional was quoted saying that it is a “sad day for drug regulation.” Those skeptical individuals are nervous about the type of message this is sending to other drug companies in regards to drug approval. Although it is unknown how the drug exactly increases sexual desire, a successful public relations campaign for Addyi is what paved the way for its approval, and this type of strategy is what other health care professionals are nervous about in future situations - pressuring the FDA to approve riskier drugs through public relations campaigns.
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