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FOR THE 34-EMPLOYEE company Sprout Pharmaceuticals, August marked the end of long and difficult battle that began when the company was first founded in 2011.
On 18 August, the Food and Drug Administration (FDA) in the United States gave a green light on the company’s sole drug, flibanserin, which comes in the form of a little pink pill designed to spark sexual desire in women suffering from hypoactive sexual desire disorder (HSDD), where they have a chronically low desire to have sex.
And as earlier this week, the drug is available for use in the US, with a prescription.
Business Insider spoke to Sprout Pharmaceuticals CEO Cindy Whitehead back when the drug was approved in August about the obstacles she faced to get this drug approved.
Since Viagra’s approval in 1998, 24 drugs for male sexual dysfunction have been approved. Seventeen years later, women have their first to treat a similar condition.
“It’s breaking up their marriages, it’s really having them feel lesser,” she said of women with hypoactive sexual desire disorder, the condition flibanserin is approved to treat.
I think the possibility of providing women access to a treatment really meant a lot to me.
The disparity from a scientific standpoint makes sense: Men get aroused when blood flows into their genitals. Women don’t respond that easily.
For women, researchers have to look at how to get the brain stimulated to increase sexual desire. But that’s easier said than done.
Pharma giant Boehringer Ingleheim was the first to start developing flibanserin back in 2006, when an antidepressant drug actually increased libido instead of suppressing it, a common side effect for antidepressants.
The FDA rejected the pill in 2010 because it didn’t show a significant change in women’s labedo over placebos. That’s when Whitehead swooped in and snatched it up.
She still thought the drug had the potential to be useful for women with HSDD.
“I saw this spectacular science that was going to be abandoned,” Whitehead said.
And I thought it was going to be abandoned frankly because of a society unwilling to have a frank discussion about sex for women.
It took another rejection from the FDA in 2013 before Sprout could figure out how to meet with the agency’s criteria and move the drug along toward approval, which it finally achieved last week.
“The FDA rules on science,” she said. “And on Tuesday, they ruled on science.”
Just days after FDA approval, Valeant announced its plans to pick up Sprout for $1 billion, with future milestone payments that haven’t been disclosed.
For Whitehead, an acquisition of her small Sprout team made a lot of sense.
I think what this affords us is to do that in a way that we as a 34-person company wouldn’t have otherwise been able to. I think that means … affordable access for more women.
Whitehead said the acquisition’s been in the works since the FDA panel ruled in favor of Addyi — the market name for flibanserin.
Now that the drug’s approved, Whitehead said the next step is to focus on the short term goals of trying to get it on the market right way.
“I’d love to see this usher in a new era of interest in terms of investment and research for conditions like HSDD that uniquely impact women,” she said.
But there’s still skepticism about how well the drug works, and at what cost. The drug carries some rather serious warnings. And it can cause severe side effects like a drop in blood pressure and fainting when consumed with alcohol.
What’s more, although it was effective in trials in raising the number of times a woman has satisfying sex (which the scientists label “satisfying sexual episodes”), it didn’t improve sexual desire — the very thing the drug was designed to do.
Women in the trials taking flibanserin saw an increase in the number of times they had satisfying sex from roughly 2.8 times a month to an average of 4.5 times a month, an increase of about 1.7 times.
Here’s the problem: Women taking just a placebo in drug trials had more SSEs too, albeit by a slightly smaller number. Women taking a placebo saw their number of SSEs rise from an average of 2.7 per month to 3.7, an increase of 1.
In other words, controlling for the placebo effect, flibanserin’s effectiveness amounted to roughly one extra episode of satisfying sex each month, David Kroll reports in Forbes.
This was most likely one of the reasons the FDA has rejected pharma companies’ petitions for it twice, according to FierceBiotech.
Yet the company making the drug, Sprout Pharmaceuticals, says this is enough of an increase to make it available to women.
And now the FDA appears to have agreed.
“The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research at the time of Addyi’s approval.
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Good.
@FlyingDogThing: makes total sense
@Dixieblue: it should be visors for primary school teachers, not masks.
Facial expressions are important for socialising young children and even more important for children with certain special needs.
Hard for kids to develop socially when they’re looking at a non-expressive half of a face all day.
@Henri Poincaré: unfortunately visors are not as effective as masks… and remember they will all be in relatively close quarters for long periods. We don’t live in ideal world unfortunate, so whilst seeing facing expressions would be nice, we’ll have to work with what we’ve got for now
@FlyingDogThing: Teaching requires serious attention to facial expressions in order to be effective. Context and meaning are everything, and beyond just learning subject material, it’s vital for social development. This is not ‘good’ it’s actually a disaster for children. But hey, you got all those thumbs up with the first comment. A plus for you.
@michael: how do blind people learn?
@Henri Poincaré: Clear masks are available. May be a possible solution where facial expressions need to be seen
@michael: Some participation is infinitely better than none. Do you think we should just let them all bale in there with no protection?
@FlyingDogThing: how long till students get bored of wearing masks this will last months just counting the second wave? 100s of students using 20 or 30 toiletes in each school daily…
@Matthew O’Kane: cool then they can be sent home until their parent acts like a parent and gets them to wear it or they don’t go back.
@fintolini: and yet visors are apparently acceptable on public transport..
@Craic_a_tower: I’d expect using teaching methods radically different to those used to teach sighted people.
@Craic_a_tower: I’m not even going to dignify that with a proper response
Try teaching a class at any time let alone when they can’t see your expression or the nuances of your meanings. People who clap this and say ‘great news’ have no idea of how education works in reality. Keep clapping, sure you’re all great lads.
@michael: U a teacher Michael? Cos every teacher I’ve spoken to wanted this.
@michael: Would you prefer to keep schools closed? It’s about doing what’s best in the circumstances, not in an ideal world that doesn’t, never has, and never will exist.
@michael: As a teacher I very happy with this. I can get 12/30 of my students in a room at 1 m so social distancing just isn’t happening. Masks will definitely put me more at ease.
@Graham Manning: of course he’s not a teacher. He’s a moaner. Loves a whine.
@michael: Is it ideal? No. Is it necessary? Absolutely!
@Sid: He says, moaning.
@michael: it’s called trying to make the best out of a bad situation. You do realise we are in the midst of a pandemic.. Jesus wept, I swear some people just don’t know how to not complain at everything in their life
@michael: I’m a teacher and am happy with the advice.
@Graham Manning: I am a teacher and no I’m not at all happy about it. And yes I’m aware we don’t live in a perfect world, in fact we are currently living in a police state facilitated by a compliant public. Those teachers who say they are happy with this won’t be so pleased when they actually need to police it and watch their students suffer under the blanket of fear we’ve wrapped around them. This is NOT common practice around the world. But dear old Ireland are always top of the class. Well done one and all.
@michael: damn you’re pretty dim and conspiratorial for a teacher. I’m also a teacher, have zero issue with it. Nor did the students I met up with yesterday. Time will tell but at present it’s one of the necessary measures.
If it reduces transmission and keeps people well, then I’m happy to do it.
-There are still just 5 confirmed covid cases in ICU (nothing came of that ‘sharp rise’ in suspected ICU cases reported yesterday
- 11 confirmed cases in Irish hospitals (up 1 from yesterday’s figure of 10)
- 0 covid admissions to ICU in the last 24 hrs
- 0 covid discharges from ICU in the last 24hrs
- 0 covid admissions to hospitals in the last 24hrs
- 0 vivid discharges from hospital in the last 24hrs
Figures are updated twice daily on the Ireland’s Covid Data hub
There are hundreds of suspected figures in hospitals every day and they come back negative over 99% of the time.
@Anna: I presume you will keep these posts going until you or somebody close to you gets the virus. Have you any idea of the effect it has if you get the virus proper. Think glandular fever. Months to recover.
@Anna: ok “Anna”
@Aidan Mitchell: all on the government back covid data hub. Anybody can check those figures for themselves
@Anna: no anna they can’t do that appeasers are there to appease there governance.. common sense and questions are over ruled
@Anna: anybody can do anything.
@Anna: so?
I@Anna: id say your great crack at a party?
Good, but a huge percentage of communication is visual, watching people speak. Its not going to be easy on anyone at school.
@Rochey77: it doesn’t matter as they’ve already received the funds… What?? I’m guessing collective procurement took place or was it just distribute to schools to decide what to spend it on, if anything?
Brilliant. So, they can adopt a similar position in the Dail and save the country €25k (or however much it’s costing us to use the NCC) per day then, right?
What a shambles of a government making it up as they go along , what’s about kids who have asthma or other conditions
@Wiggy Wigsters Fitness: you will see this not suiting some kids and theyll be home schooled.
If there are 20 students in a class and 18 are wearing masks, 2 with genuine reasons not to then it’s still better than none wearing them. I still haven’t seen anywhere that there are conditions where wearing a mask is detrimental to a person’s health though.
@Wiggy Wigsters Fitness: If they have a medical cert they will be exempt.
@Macca1986: Really? You act like that’s an easy thing to get.
@Wiggy Wigsters Fitness: do you ever stop moaning
@Wiggy Wigsters Fitness: asthma kids stay home. It’s a choice … wear mask or risk death.
Seems wise, but don’t think its gonna work. Unless things have radically changed since i was at school, teenagers couldn’t keep their full uniform together even when they were told they would be suspended. I would also imagine its hard to teach if students cant see your expressions. Not sure what the solution is, but cant see it working.
That’s actually good to be fair
I’d imagine youngsters and teachers wont be happy having to wear masks in school all day every day but I can see the logic behind it. Now, what will they do with primary?
@Macca1986: you’d imagine wrong re teachers at least. Yet to speak to one not in favour of masks and visors.
@Macca1986: students will have no bother wearing them.
@Macca1986: Teachers I know are in favour certainly.
WHO SAID THAT
@Mark: you own the Internet dear sir
It’s not right to put kids through this…
@Tony Garcia: you are right we should make them learn they caused a family member to die later in life
@Tony Garcia: they’re hardly being tortured. Grow up
@Tony Garcia: it’s not the occupation of France they have to endure. Or the Thai tsunami … it’s a bit of cloth over their gobs.
Wonder how it will go over here.
Two german schools closed after two days of opening
@Philip King ⚡️: Philip how very dare you point out the possibilities and realities….you’ll upset people if you keep that up!
It’s also beggars belief how gyms are still open ??? As a gym person I’ve stopped going since last week did not feel one bit safe , staff not enforcing hygiene procedures , I now train at home with the equipment I have ,
@Wiggy Wigsters Fitness: Your decision. Stay at home and let the rest of society get on with keeping our country and mental health afloat.
@michael: what A GobS#ite you really are
@michael: Why should anyone stay at home because a few fools decide to make the wrong choice and ignore expert advice ? Drop the selfishness, this isn’t just about you.
Are they having pints with no food in the meat plants?
Is it not true that there has been hardly any transmission in schools around the world ? Especially primary schools. Why does Ireland have to be different?
@Virgil: I suppose the point is Virgil that adults also work in the school community and that in itself is a problem. Germany has closed two schools because a teacher has tested positive. Apart from this there’s the difficulty of children going home to households to immunocompromised adults. In fairness there will never be an ideal solution but governments worldwide are operating in uncharted territory given this is a new virus and they don’t have much research to go on regarding school transmission given that schools shut down pretty quickly. People citing Sweden forget that they had very different reporting protocol so their numbers may be a bit sketchy.
@Virgil: Firstly evidence is emerging that schools can be problematic. Secondly, Irish schools have one of the highest pupil/teacher ratios in Europe with classes of up to 30+ children in tiny classrooms which makes social distancing very difficult.
@Virgil: Our class sizes are some if the largest, we aren’t good at following directions or rules, our kids are even worse…this should be interesting.
@Sorcha Ní Shúilleabháin: if we can halve the pupil teacher ratio can we halve the teachers salaries.
@Michael Ring: @Michael Ring: how about you go and teach? See what you think of the salary then. I used to teach, and it was a thankless job with a bad support system. Comments like yours have zero understanding surrounding the hours, stress and paperwork that the job requires on top of actual teaching and monitoring progress of a few hundred students. I don’t teach anymore and I wouldn’t go back if they tripled the salary. Those who teach should be thanked. They take care of your children in normal times for 7 hours a day and prepare them for the future.
@Michael Ring: no, ya can’t. Any other questions?
This only took 6 months for them to realise that everyone else who has been working through this pandemic, have been wearing some sort of face coverings. For those who choose not to wear them and are refusing to work or may have underlying issues may no longer be able work in the teaching profession and will have to choose another career.
@Niall Donnelly: no teacher is refusing to work. To date, none is refusing to wear ppe. Any that can’t because of a certified medical reason will work from home.
@Graham Manning: to date , you are right.
@Graham Manning: that won’t work. You can’t work from home being a teacher while the students are in class being taught by a substitute. You won’t be able to pay a teacher and a substitute. It’s either one or the other. You can’t keep the position open for possibly years while the substitute is in limbo.
@Niall Donnelly: a cohort of students will also not be in school. It absolutely can work. Until we have a timeframe and more information no longer term decisions re careers will be taken. Is it possible some teachers will have to, down the road, retire early? Yup but we’re not there yet.
What of adults and students with respiratory/immune system issues or autistics who can’t wear the mandatory coverings?
@Mary Morrisey: they shouldn’t be in the building. What makes you think autistic people en mass can’t wear masks?
@Mary Morrisey: If a person can’t wear one they will have a medical cert. Simple.
@Mary Morrisey: I’m autistic and I’m well able to wear masks, don’t generalise
@Graham Manning: just being argumentative as usual Graham. Is it so hard to just recognise that many people with ASD will be unable to wear a face covering? Couldn’t you just let the very valid point slide by without the smartarse, half-baked response?
No. You couldn’t; you never can.
@Mary Morrisey: not autistics people with autism.
@FecklessBear: well seeing as I work with autistic students tis something I’m pretty well placed to comment on. And it isn’t a valid point as it implies all autistic people can’t wear masks which is nonsense.
@Lisa Quinn: up to the person in question but the community tends to prefer autistic as opposed to “person with” by a pretty substantial margin.
Good
Why not face shields? Surely a better option. Maybe they don’t work as well? Communication with face marks will be very difficult.
@Seán O Ciara BA/ PDE: ill be wearing both.
@Seán O Ciara BA/ PDE: not as effective… but it is possible to buy clear face masks..
We cannot get adults to wear masks and you want children and teenagers to comply . Good luck with that ! A good idea but honestly I cannot see it working .
@Mary Mc Carthy: a bit like the Euro. Many said it would never catch on.
This is how I see that working. Teacher and 20+ kids with masks. Some masked kid says “nobhead”… teacher looks around … “who said that?” ….and so the fun begins …
@Paul Whitehead: not just students. I’m in plenty of other teachers classes and may be tempted to engage in a bit the that myself. Wonder which kid I’ll blame???
Why? Ireland has the lowest investment in education in the EU, the largest pupil teacher ratio and your suggestion is; if we cut the class sizes we cut the teachers salaries! Great logic there!
So, students must wear masks but teachers/staff don’t have to if they can stay 2 metres away. Why don’t students have this option?
@Mary McDonagh Faherty: staff will be wearing em too. And they dont have that option cos it’s not possible to socially distance in a school.
Keep the schools closed until November and extend the academic year into next June and July.
@Valthebear: yes someone speaking sense. Wouldnt suit the “me feiners” though!
Government say wear face masks. First thing some say is what group can I think of that masks will create a problem for. That’s what the unions have been doing as well. Here’s a mad idea. Instead of trying to think of problems with masks try to think of solutions. Much harder I know and probably why so many find the negative band wagon so much easier to jump on. So just after you come up with your list of reasons masks create a problem try to come up with a solution to each of those problems.
@Michael Ring: students are in class for approx 6 hours, that’s a long time to wear a covering over ur face, I wear one while shopping and cant wait to get it off my face when I leave the shop. It’s a hard thing to get used to, so if people raising concerns upsets u , soz about that. Didnt read any solutions in your post by the way
@Michael Ring: odd claim re unions.
@Michael Ring: allow smoking on buses and in confined spaces. The smoke in the air will stop it traveling
They can miss 20 days that’s the same as before, even a sniffles will have them out of school wtf
@Jeni Moriarty: they can miss way more than that.
I don’t think many of the comments are from astronauts who can operate only with masks. We’d better get used to them.
And I think it’s eyes that convey feeling anyway
have your say