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Female Libido Pill Took Long, Winding Route To Market

Sprout Pharmaceuticals CEO Cindy Whitehead holds a bottle for the female sex-drive drug Addyi at her Raleigh, N.C., office on Tuesday, Aug. 15, 2015.
Associated Press
Sprout Pharmaceuticals CEO Cindy Whitehead holds a bottle for the female sex-drive drug Addyi at her Raleigh, N.C., office on Tuesday, Aug. 15, 2015.
Female Libido Pill Took Long, Winding Route To Market
Female Libido Pill Took Long, Winding Route To Market
Female Libido Pill Took Long, Winding Route To Market GUESTS:Irwin Goldstein, president, Institute for Sexual HealthBarbara Gattuso, participant, Addyi clinical trial David Peters, family therapist

Our top story, the headlines are full of the news about a new drug some call the female Viagra. Addyi is the first pill approved by the FDA to increase women's libido . It's being called a breakthrough for women's health, now I'm a pink belt to counter the men's blue pill to help achieve sexual satisfaction. Critics are warning this pill doesn't work like Viagra, its ability to increase desire and sexual satisfaction is limited to works by altering the chemicals in a woman's brain. Joining us to talk about the benefits and risks, Irwin Goldstein, president, Institute for Sexual Health and David Peters, family therapist. Dr. Goldstein, how does this drug were? It has three actions on the brain. Is an inhibitory chemical called serotonin. We know serotonin well through the depression era when people have less serotonin they get depressed. There drugs that raise serotonin that treat depression. We are aware that changes in brain chemistry affect mood and behavior. This drug increases -- decreases serotonin. The other side is excitation. Excitation chemicals have two of them. Dopamine and Chantix. This raises dopamine. It also increases norepinephrine which is the adrenaline Drive. Three actions, to increasing excitation and when decreasing inhibition with the some total of improving libido. What specific kinds of women's sexual problems is Addyi designed to help? It's a designed to help women with hypoactive sexual disorder. Women who have persistent inability to have thoughts and fantasies and be responsive and want to partake in sexual activity. It causes them or their partner distrusts. It's not explained by an otherwise medical situation like fever, disease, etc. Is there an age limitation on women taking the strike? Low interest is an all ages. This indication was that it on women who are premenopausal. There was also large study done on posted a possible and found to be safe and effective as well. How much does it improve a woman's sex life? Sexuality is complicated. There are many reasons for having low interest like a fight with your partner or your busy at work. In the true patient, the woman who has persistent absence of all the things we talked about, the drug works quite well. It was selected by FDA to be safe and effective. Didn't only increase sexual event by one per month? That's globally within the whole population. In many women increase in a lot more. In sum, less. We speak to her patient, women with this did not have a great life. They are partake in sex as duty. It is unhappy to have what would otherwise be a satisfying life but not be part of it's because you're not there. Before I talked to Barbara, it said they referred to this as an additional one sexually satisfied event per month which is an odd way of phrasing it. Are we talking about orgasms? The FDA required the woman who render the condition of benefit by a satisfying sexual event. Using her judgment as to what that meant. It didn't necessarily mean orgasm. The program is not problem with that outcome of libido its way downstream. It could be that you bonded well with your partner and that was it. We don't use that. It was FDA choice. We also have Barbara Gattuso, participant, Addyi clinical trial. You have endured a condition is more severe an ongoing the loss of sexual desire Yes. It can be a sudden loss like a light switch goes on or off. It can develop actually over a period of time. Is still prevalent and needs to be addressed. You think the condition might be genetic? Yes. I please so as according to what Dr. Goldstein had indicated prior. How does this pill, Addyi , how did help you? It gave my desire back to me after about 25 years of feeling inadequate and having duty sex and have been feelings of shame, low self-esteem, all of these things are part of HSDD. Fortunately for me I have a wonderful husband and a great marriage. There's so much strength in that. From what I'm finding out, speaking to a lot of individuals, their marriage has broken up including my daughters is on the line right now because of HSDD and not such an understanding has been. I hate to see this happening all over the world. It's not just a local events, it's global. The fact that this drug works on chemical levels is troubling to critics. Does the trouble you? I can hardly wait till October comes around. It has made me the total woman I used to be. It does not trouble me at all, not one bit. Every drug you take affects something in your body. Even an antidepressant, they don't sit there and contemplate what's it doing to my brain? May take it on the advice of their position to help them cope. Dr. Goldstein, barbarous condition a sense unique. I mean that in terms of the kinds of sexual dysfunction that might affect most women. Is this drug will be for the average woman? We have thousands of women like her in our clinic and practice. One in 10 women. You're looking at 10 to 15,000,000 women like this in our country who have HSDD. That's different from a fight with your husband or a child that is sick or upset and you lose interest. She has had this for 25 years. They acquire some capacity and have interest in they know what to expect. Then they lose it and don't know why they visit. The disease called Parkinsons, Parkinsons is missing dopamine, does anyone question taking Parkinson's medication to raise the dopamine so that they can move and be human again? We have many disorders that are chemically related in the brain. We have a biologic opportunity with that we've never had before. This is choice. Women had no choice before and now they had choice. Why was the truck like this designed to affect the body like Viagra as opposed to the brain chemistry? Therefore divisions of sexual response. There's a desire phase, there's an arousal phase,, that leads to orgasm and the fourth classification is when there's pain during sexual activity. This pill is designed to deal with sexual problems in women with libido problems. By the way, prior to the drug being given to them, delusional company was a different company. We have full intentions to study interest with men and low interest. 25% of relationships the women have far more interest than the man. When they drop the benefit -- medication spot focused on the women. This drug works to lower inhibitions, it works to increase a sense of pleasure through dopamine. It highlights the importance of the brain and sexual stimulation. Do you think taking a pill is a good way to resolve this kind of issue? I think the key is to be able to correctly identify what is true hypoactive sexual desire disorder. In my practice I have couples come in with a complaint that one or the other partners isn't interested in sex. After about five or six sessions, we discover what's really going on that's undermining the sexual relationship. We make a change in the relationship, suddenly arousal is back. We're still in an age where both the husband and wife are working for personals, women are doing 80% of the housework and men doing 20%. That's enough to kill your sex drive. The key is are we correctly identifying what's true hypoactive sexual desire disorder or we overprescribed up the situation where it's not call for. I want to point out that when it comes to attention deficit disorder in adolescence, or depression and grown-ups, we have a significant over medication of the population and overdiagnosis were people get a pill first without disco -- discussing with the behavioral professional. It could be a life-saving opportunity for those who truly have HSDD. It could be undermining and delay the true resolution for couples or individuals weather's other factors that are undermining desire. There is a problem of over medicating people and people go into their doctor and say I'm just not telling sexual anymore. They get this pink pill. I've been in this field for 40 years. We have a very large facility here in the San Diego. We have a sex therapist, a physical therapist and myself and a visit is a four hour visit. Go through hormones and a bunch of tests. We need to decipher situational hypoactive desire from true generalized acquired which is what this drug is for. I think under appropriate circumstances, until yesterday we had only David to help these women. There a group of women that don't respond to those interventions. There are some women whose problems are genetic or something to do with their chemicals for which talk therapy is just not going to do. Talk therapy should be part of all therapies. With a sex therapist is part of every interaction, it's a competent business. I think we're so excited that women now have choice. It is exciting that women have choice. I want to say it's a woman goes into Dr. Holstein's clinic which is well respected in this town, they are likely to get very very good care. The question is this in the long run because it's going to be a lot of money on the line with this medication as with others. The majority of psychiatric medications described by practitioners that attempt at behavioral health intervention. If the rules change allowed a general practitioner to freely prescribed this medication without the rigorous evaluations that they are requiring now, we could end up with a great amount of over prescription and neglecting the true causes of hypoactive sexual desire. Barbara, I want to ask you that people think consuming a prescription pills daily with these powerful brain altering chemicals he a lot to ask for the result of one additional sexual satisfying experience a month. I want to get your response to that. A couple of things, one wonderful sexual event a month is better than none. Which is what I am right now. Even one would be amazing. It would draw couples closer together. As far as taking a pill a day, people take high blood pressure medication every day. Sometimes twice a day. Some take an antidepressant they take it once a day. I do not see any downside to this. Although I see a possibility of overprescribing this. I believe that sprout has covered that in making sure doctors are qualified. Spot is the pharmaceutical company that is saying this? I want to make a comment the had no drugs available for men. Women have had no opportunity to seek healthcare providers other than maybe the psychologic akin to. This opens the possibility for a woman to go to a doctor, and have discussion of women's sexual health issues. It's an amazing advance of the has just happened. Education needs to follow as well as training. It's probably going to be a great boon for Davis profession. I want to thank all three of you. Barbara Gattuso, participant, Addyi clinical trial And Irwin Goldstein, president, Institute for Sexual Health and David Peters, family therapist.

Federal health officials on Tuesday approved the first prescription drug intended to treat premenopausal women suffering from a sudden lack of sexual desire. The daily pill, which acts on brain chemicals, followed a long, winding path to approval, including two previous rejections by the Food and Drug Administration.

Dr. Irwin Goldstein led clinical trials in San Diego on the drug known as Addyi. Goldstein will join David Peters a family therapist in San Diego to discuss the drug, reasons for its use, and what other relationship issues might contribute to loss of sexual desire. Barbara Gattuso, who was a participant in the clinical trial of Addyi will also join the discussion.

Here's a look at the history:

— Pre-2009: German drugmaker Boehringer Ingelheim studies its drug, known chemically as flibanserin, as a treatment for depression in men and women. The drug had little effect, but researchers noticed patients reported increased sexual desire, suggesting an alternate use.

— 2009: Boehringer submits the drug to the Food and Drug Administration for approval to treat female hypoactive sexual desire disorder, a condition described as emotional distress caused by a lack of sexual desire. The FDA had never approved a drug for that condition or any other female sexual disorders.

— June 2010: A panel of FDA advisers votes unanimously against the drug, saying its benefits are outweighed by its risks, including side effects like dizziness, fatigue and fainting.

— Late 2011: Boehringer abandons the drug and sells it to Sprout Pharmaceuticals, a small North Carolina company.

— March 2013: Sprout resubmits the drug to FDA with additional data showing its benefits using a new measurement technique.

— September 2013: The FDA rejects the drug a second time, saying its benefits are "numerically small" and still don't outweigh "substantial safety concerns."

— December 2013: Sprout files a formal dispute against the FDA, arguing the agency should approve the drug without any additional data.

— February 2014: The FDA responds by proposing Sprout conduct additional studies, including one examining flibanserin's effects on driving, because of its drowsiness side effect.

— February 2015: Sprout resubmits the drug to the FDA with the requested studies. At the same time, the company helps fund a campaign called Even the Score, which lobbies the FDA to approve sexual medicines for women.

— June 2015: A panel of FDA advisers votes 18-6 in favor of approving the drug, with safety restrictions.

— August 2015: The FDA approves flibanserin, branded Addyi, as the first drug to treat any type of female sexual dysfunction. The drug includes a black box warning about side effects.

Corrected:
KPBS' Maureen Cavanaugh, Patty Lane and Peggy Pico contributed to the Midday and Evening Edition segments.