F.D.A. Approves Addyi, a Libido Pill for Women

By ANDREW POLLACK, AUG. 18, 2015 - NY Times The first prescription drug to enhance women’s sexual drive won regulatory approval on Tuesday, clinching a victory for a lobbying campaign that had accused the Food and Drug Administration of gender bias for ignoring the sexual needs of women.

The drug — Addyi from Sprout Pharmaceuticals — is actually the first drug approved to treat a flagging or absent libido for either sex. Viagra and other drugs available for men are approved to help achieve erections, or to treat certain deficiencies of the hormone testosterone, not to increase desire.

Advocates who pressed for approval of Addyi, many of them part of a coalition called Even the Score, said that a drug to improve women’s sex lives was long overdue, given the many options available to men.

“This is the biggest breakthrough for women’s sexual health since the pill,” said Sally Greenberg, executive director of the National Consumers League.

Continue reading the main story RELATED COVERAGE

A luncheon at Ris in Washington in July honored Cindy Whitehead, center, chief operating officer of Sprout Pharmaceuticals.Aid to Women, or Bottom Line? Advocates Split on Libido Pill JUNE 13, 2015 A tablet of flibanserin, a drug to increase sexual desire in women. The medicine had been rejected twice by the F.D.A. before being recommended for approval by an advisory committee.‘Viagra for Women’ Is Backed by an F.D.A. PanelJUNE 4, 2015 Barbara Gattuso, 66, with her husband, Gregg, 67, in Boston last week, on vacation from their home in San Diego. “I was the one initiating sex, much to the surprise of my husband,” Ms. Gattuso said at the F.D.A. workshop in October.‘Viagra for Women’ Gets Push for F.D.A. ApprovalMAY 31, 2015 But critics said the campaign behind Addyi had made a mockery of the system that regulates pharmaceuticals and had co-opted the women’s movement to pressure the F.D.A. into approving a drug that was at best minimally effective and could cause side effects like low blood pressure, fainting, nausea, dizziness and sleepiness.

In announcing the approval, Dr. Janet Woodcock, a senior F.D.A. official, said the agency was “committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

The F.D.A. decision on Tuesday was not a surprise since an advisory committee of outside experts had recommended by a vote of 18 to 6 in June that the drug be approved, albeit with precautions required to try to limit the risks and ensure that it was not overused.

Addyi’s label has a boxed warning — the strongest kind — saying the drug should not be used by those who drink alcohol, since that can increase the risk of severely low blood pressure and fainting. It is also not to be used with certain other drugs and by people with liver impairment.

The pill can be prescribed or dispensed only by doctors and pharmacists who watch an online slide presentation and pass a test of their comprehension. Women are advised to stop using the drug if they see no effect after eight weeks.

The big question now is how many people will use Addyi (pronounced ADD-ee), which is also known as flibanserin and has been called the “pink Viagra.”

According to one survey, about 10 percent of women suffer from hypoactive sexual desire disorder. The F.D.A. said the drug was approved for women whose loss of sexual desire causes marked distress or interpersonal difficulty and is not the result of illness, relationship problems or side effects of other medicines.

Dr. Lauren Streicher, associate professor of clinical obstetrics and gynecology at Northwestern University, said she sensed great interest for a drug like Addyi among her patients. She said the drug’s availability would encourage many women to talk to doctors about their sexual problems for the first time.

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“I think this is going to change the conversation that’s taking place in medical offices across the country,” she said, much as the 1998 approval of Viagra made it acceptable for men to talk about erectile dysfunction.

Leonore Tiefer, a sex therapist at the New York University School of Medicine and critic of the drug, predicted the restrictions on use would keep Addyi from becoming popular. “It’s going to be more trouble than it’s worth,” she said.

Cindy Whitehead, the chief executive of Sprout, declined to predict sales of Addyi, which she said would be available starting Oct. 17.

To allay concerns that the drug would be overused, Sprout has said it would not advertise on radio or television for 18 months after the drug’s approval. Ms. Whitehead said the company would focus its marketing on doctors, not consumers. She said Sprout planned to hire 200 sales representatives, enough to call on about 30,000 doctors, mainly obstetricians and gynecologists but also some psychiatrists and primary care physicians.

She said the exact price of Addyi had not been decided, but suggested it would be roughly equivalent on a monthly basis to erectile dysfunction pills. Those pills are generally taken when needed, while Addyi is supposed to be taken every night before bedtime. That makes a direct comparison difficult. But 10 Viagra tablets, a possible monthly allotment, cost about $400.

It is not clear if insurance companies will pay for Addyi.

Ms. Whitehead said that she expected many would, with a co-payment of about $30 to $75 a month. Sprout will assist patients with co-payments, she said.

Some doctors might use the drug beyond the uses in the label, which doctors are allowed to do.

Dr. Streicher said that although the drug was approved for premenopausal women only, she “absolutely” would prescribe it for postmenopausal women as well.

Dr. Irwin Goldstein, a sex-medicine doctor in San Diego who has been a consultant to Sprout, said he would not necessarily withhold the drug from casual drinkers. Some women might find the risk of side effects acceptable if their relationships are in jeopardy because of a lack of desire, he said. “That’s a risk, too.”

Dr. Goldstein said he would also not rule out prescribing the drug off-label to men.

Ms. Whitehead said there was interest in learning whether the drug would work for men, but Sprout’s priorities would be to get it approved next for postmenopausal women and in foreign markets.

Continue reading the main story RECENT COMMENTS

Juliet 5 hours ago I understand objection to this pill in terms of thinking we are in an already over-medicated society.But I don't understand the smug,... Katherine 5 hours ago This drug doesn't work (look at the data). If somebody wants something that actually really works I suggest taking a trip to Washington or... rick baldwin 5 hours ago AH,Spanish Fly meets the drugstore-this stuff will be resold to men starting tomorrow. Big Pharma strikes again. SEE ALL COMMENTS WRITE A COMMENT Addyi is thought to work by changing the balance of certain brain neurotransmitters like dopamine and serotonin.

There are disagreements among researchers as to what constitutes normal sexual desire in women. And there have been difficulties bringing to market a drug that would treat low desire.

Procter & Gamble failed to win approval for a testosterone skin patch for women about a decade ago. The F.D.A. rejected Addyi twice, in 2010 and 2013, citing marginal effectiveness and the side effects.

In one trial, for instance, women who took the drug had an average of 4.4 “satisfying sexual experiences” a month, compared with 3.7 for women getting a placebo and 2.7 before the study began. The drug did not increase desire more than a placebo when measured by a daily diary, but did do so modestly when measured by a monthly questionnaire.

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After the first rejection, Boehringer Ingelheim abandoned the drug. Ms. Whitehead and her husband, Robert, were at the time running a company that sold a testosterone product for men. The Whiteheads sold that business and formed Sprout to acquire flibanserin. Based in Raleigh, N.C., Sprout, a privately held company, had raised about $100 million, Ms. Whitehead said.

After the second rejection, various women’s and health groups formed Even the Score.

Sprout is paying at least part of the expenses for the coalition, whose members include the National Council of Women’s Organizations, the Black Women’s Health Imperative and the Association of Reproductive Health Professionals.

Even after the favorable advisory committee vote, critics of the drug sent letters to the F.D.A. urging it to reject Addyi. The agency usually follows the advice of its committees, but does not have to.

One letter, written by Dr. Tiefer of N.Y.U. and signed by about 100 others, said it was “absurd” to expect that young women taking Addyi would refrain from drinking alcohol. Another, by the PharmedOut project at Georgetown University Medical Center, which also had more than 100 signatures, said that the “unprecedented and unwarranted manufacturer-funded public relations campaign” may have confused the advisory committee members. A third letter, from sex researchers in the Netherlands and Belgium, said the drug was based on the mistaken notion that lack of spontaneous sexual desire, absent stimuli, was abnormal.

CONTINUE READING THE MAIN STORY 149 COMMENTS Even the Score is planning to stay in business, hoping that the approval of Addyi will spur other companies to develop drugs for women’s sexual health.

“It’s never been about one treatment,” said Ms. Greenberg of the National Consumers League, which received a contribution from Sprout and which formally joined Even the Score this month.

“For us to fold up our tent would be premature.”

Why You Should Be A Morning Person

Originally Posted at: Medium

What is one thing most successful people have in common? They get up extra early and make the most of the morning. Here’s why:

Waking up early gives you time to think before the buzz of the day begins. To put it simply, the early morning is “you time” — a time to lay out your priorities for the day and make progress against them, before others are demanding your time and attention. It puts you firmly in control of each day.

Of course it is awfully hard to get out of bed, but that’s exactly why early risers have the competitive advantage over everyone else. They tackle the day while others hit the snooze button.

Here are just a few examples of ultra-successful early risers:

• Virgin Founder Richard Branson wakes up at 5:45am, even when he’s on his private island, and uses the morning for exercise and breakfast before starting work for the day
• First Lady Michelle Obama starts her day at 4:30am for a workout before her kids wake up
• Apple CEO Tim Cook gets up at 3:45am every day to catch up on email, hit the gym, and make a Starbucks run before heading to the office
• Starbucks CEO Howard Schultz gets up at 4:30am to get a workout in (often a bike ride with his wife) — and of course to make some coffee to get his day going
• Disney CEO Bob Iger rises at 4:30am and uses the early morning to read the paper, exercise, listen to music, catch up on emails, and even watch TV
• Vogue Editor-In-Chief Anna Wintour wakes at 5:45am to play an hour of tennis before work demands hit
• GE CEO Jeff Immelt wakes up at 5:30am and gets in a cardio workout while reading the paper and watching CNBC

Did you notice another consistent trend among all of these ultra-successful people? Everyone’s morning ritual includes exercise as a key component.

In addition to the overall health and fitness benefits, studies have shown that moderate-intensity exercise for 20+ minutes produces a mental and emotional boost for the following 12 hours! This means that these business leaders are likely more clear-headed, effective, and productive at work as a direct result of their morning workout. The exercise time also allows them to think and problem-solve without interruption, so they hit the ground running once they get into the office. Morning exercise is an incredibly efficient use of time.

In addition to waking up extra early and exercising, here are a few more morning habits to get your day moving in the right direction:

• Drink 16 oz. of Water Upon Waking — Rehydrate after your 7–8 hours of sleep
• Make Your Bed — Making your bed every morning is correlated with better productivity throughout the day
• Eat a Healthy Breakfast — Fuel your body for the demands of the day (led by energy-packed fruits and vegetables)
• Drink 1–2 Cups of Coffee — Give yourself a morning boost while reaping the proven health benefits
• Catch up on the News — Use the quiet time to know what’s happening in the world around you
• Prioritize Your Day — Establish your top priorities and think about how to tackle them

All of this sets you up for success before your “work day” even begins, whatever form that may take for you. Being a morning person isn’t reserved for just C-level execs. Everyone will benefit from implementing these good habits.

Think it’s not possible for you because you need the extra sleep? The experts would say to get to bed earlier the night before to make the early wake-up call tolerable.

These tips and success stories help motivate me to get out of bed when all I want to do is sleep a bit more, and hopefully they also inspire you to make the morning your secret weapon!

Men’s Hormonal Health: Spotting the Red Flags of Low Testosterone.

Low T is no joke, and most men will face it at some point during their lives. The only question is: what will you do about it? Here’s what to look for and how to know when it’s time to see your doctor. You Have Low Sex Drive

It seems weird that you aren’t interested in sex anymore, right? It might not be that you don’t love your wife. It might be that you have low T. Testosterone is the male sex hormone and, while it has many functions in the body besides helping you achieve and maintain erections, sex is the number 1 function of this hormone.

You should base your changes on a predefined “norm” for you. If it’s normal for you to be sexually aroused several times a day and you’re now only aroused once a week, there’s a problem.

If you’re aroused and having sex 3 times a week and suddenly you go a month without getting an erection, you need to go see your doctor – assuming you haven’t just had a major fight with your wife or your marriage is already on the rocks.

In the latter case, book an appointment with a sex therapist.

You Don’t Have Morning Erections

It’s totally normal to have “morning wood.” In fact, if you don’t have an erection in the morning, something is wrong – way wrong. Since testosterone stimulates a man’s sex drive, it’s also responsible for achieving an erection.

When testosterone levels drop too low, achieving and maintaining an erection is impossible. Other health problems can also influence erectile dysfunction too, but this is a major cause.

You Have Low Semen Volume

It’s hard to tell whether you have low semen volume unless you pop into the doctor’s office and get yourself checked out. You will have to ejaculate into a cup, a lab analyses the output, and you get a nifty printout that you can discuss with your doctor.

There are also blood tests that you can take to corroborate the low semen volume, like FHS (follicle-stimulating hormone) and LH

(luteinizing hormone). Both of these hormones are secreted by the anterior pituitary in response to gonadotropin-releasing hormone (GNRH), which is, in turn, released by your hypothalamus.

In plan English, these are hormones that are responsible for your testosterone production. If your blood levels are too low, it’s time to take a look at why your pituitary and hypothalamus gland aren’t doing their job.

You’re Losing Your Hair

A lot of men lose their hair, and they think that’s it’s a natural part of aging. In some respects, yes that’s true. But, the reason it’s “natural” is because your testosterone levels are plummeting. Ouch.

One of the functions of testosterone is hair production. You could also experience loss of body and facial hair as your testosterone levels drop.

You’re Losing Muscle

Muscle loss is also considered “normal,” but it’s because testosterone levels are going down. The hormone plays a major role in the building and strengthening of muscle. So, if you feel weaker than normal, one of the possible causes is a low testosterone value.

And, going into the weight room might not help. According to the Mayo Clinic, those who do try to reverse the muscle loss through weight lifting find it difficult to do – that’s because you need testosterone to be strong. And, you need to be strong to lift weights and progressively overload your system. And, that progressive overload leads to more muscle.

But, without the proper amount of starting “fuel” (without enough testosterone), you can’t “get off the ground” so to speak.

You Feel Different

Being moody – irritable, depressed, or inexplicably angry at the most mundane of things are all signs of low testosterone. Since the hormone directly impacts mood through various physiological processes, having a high testosterone level is important if you want to feel your best – happy, confident, sexual, and calm-assertive.

Your Lab Values Are Low

Lab values will help corroborate a lot of your feelings and intuitions. Unfortunately, according to the Life Extension Foundation, labs can tell you that you’re within normal physiological ranges when you’re not.

Some research suggests that American men have experienced declining testosterone levels, on average, over the past few decades, making current lab ranges inadequate when it comes to properly assessing proper testosterone levels.

What to do? Rely on lab tests you’ve taken throughout your entire life? Oh, you didn’t get labs done at 20?

Look into what a 20-year old testosterone level should be and use that as a rough guide for you.

If you notice your lab values straying significantly from the reference range of a young person, it’s time to look into the best test booster on the market and sleep regimens that will increase testosterone.

If that doesn’t work, talk to Blueprint Health about TRT (testosterone replacement therapy). TRT is pure testosterone hormone that will replace what your body isn’t making.