F.D.A. Approves Addyi, a Libido Pill for Women
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 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.
Advertisement
Continue reading the main story
“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.
Advertisement
Continue reading the main story Advertisement
Continue reading the main story
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.”
The manly hormone evolved 500 million years ago — from estrogen.
Testosterone is produced in men’s testicles, women’s ovaries and the adrenal glands of both sexes. In the early weeks of pregnancy, it kicks off the development of reproductive organs for males.
1. Testosterone is produced in men’s testicles, women’s ovaries and the adrenal glands of both sexes. In the early weeks of pregnancy, it kicks off the development of reproductive organs for males.
2. After birth, testosterone plays a role in regulating processes from fat distribution to red blood cell production.
3. Long before the hormone was discovered, people ascribed youth-restoring powers to the testicles. Roman naturalist Pliny the Elder noted the sexually stimulating effects of dining on hyena genitals (with honey, of course).
4. Honeyed hyena testes sound preferable to the handiwork of Kansas huckster John Brinkley, who inserted slices of goat scrotum into men’s testicles in the 1920s, claiming it would boost virility and cure a host of ailments.
7. But testosterone is, relatively speaking, a manly hormone. Normal levels for women are 5 to 7 percent of those for men.
8. Testosterone levels decline with age. Fifty percent of men in their 80s have testosterone levels below the normal adult male range. 9. One thing that’s not declining: demand for testosterone. In 2010, 1.3 million patients in the U.S. received a prescription for the hormone. That number jumped to 2.3 million in 2013.
10. Age isn’t the only cause of low testosterone; obesity is, too. With more body fat, more testosterone gets converted to an estrogen called estradiol, which further inhibits testosterone production.
11. Low T from obesity is a particularly vicious cycle because testosterone builds muscle apparently by stimulating the production of growth hormone releasing hormone (GHRH), which correlates with lean body mass.
12. The hormone was first synthesized in 1935 after initial isolation of another male hormone called androsterone, which was distilled from some 4,000 gallons of donated urine.
13. Dutch researchers coined the term testosterone that same year.
14. There are more than 30 kinds of anabolic-androgenic steroids — the infamous ’roids used and abused to promote muscle growth — but they are all synthetic compounds mimicking testosterone’s chemical structure.
15. There is some correlation between aggressive behavior and testosterone levels, but most research lacks evidence of causation, and some results are contradictory.
16. One study found higher levels of testosterone correlated with aggressive behavior in 12- and 13-year-old boys, but not in 15- and 16-year-old boys. Studies on nonhumans have found much stronger correlations between aggression and testosterone levels.
18. The impact and timing of testosterone production varies greatly among species. For humans, testosterone production kicks in prenatally to differentiate the sexes, but production of testosterone in rats ramps up only after birth.
19. There’s scant evidence to support “natural” testosterone boosters: Elk antler velvet had no lasting effect on T levels, but royal jelly worked wonders — on hamsters.
20. Mixed research results aren’t slowing the testosterone booster bandwagon. In 2013, 25 percent of individuals taking it started treatment without bothering to get a blood test to see if they actually had low T, according to the FDA.
EXERCISE WHILE YOU REST WITH THE CVAC POD
The Cyclic Variations in Adaptive Conditioning (CVAC) pod creates an atmospheric workload, which provides the stressors needed to provoke improvements similar to the effects of aerobic and anaerobic exercise.
Our very own medical advisor, Dr. Deepa Verma, has a CVAC Pod in her office in Clearwater Florida. The CVAC pod may look like it came from space, but it’s actually a breakthrough conditioning technology right here on planet Earth.
As an integrative physician, health nut, and athlete, I am always searching for natural modalities to boost wellness and fitness. A few months prior to opening my integrative practice, I discovered some information concerning a device called the CVAC pod. Aside from looking like it may transport me to the moon, the strange object piqued my curiosity in regards to its potential use in my own life, as well as the lives of my patients.
The Cyclic Variations in Adaptive Conditioning (CVAC) pod creates an atmospheric workload, which provides the stressors needed to provoke improvements similar to the effects of aerobic and anaerobic exercise. What does this mean, exactly? The pod effectively simulates exercise, without the exercise. That doesn’t mean it’s a replacement for your workout (there’s no replacement for sweat), but it can be used in conjunction to help athletes avoid overtraining.
So, how does it work? This high-performance altitude simulator creates changes in temperature, air density, and pressure, ranging from sea level to 22,500 feet above, almost as high as the tallest peak in the Andes mountain range. In essence, it is a hypobaric chamber that prompts the body to compensate for the stressors incurred, which results in conditioning and strengthening of the body from head to toe. It is effective for the same reason athletes who train at high altitude get better workouts, only the effect is compounded: in CVAC, your body is constantly challenged; during a 20-minute session, the altitude changes between 200 and 400 times.
I’ve used the CVAC extensively in my practice, and have worked with everyone from pro athletes to regular Joes. They’ve discussed with me at length what their positive experiences with CVAC were like, but everyone has a slightly different take. Former NFL player and current Saskatchewan Roughrider Clifton Smith summed it up best:
“My experience inside of the CVAC Pod was interesting because I came in not knowing what to expect. I have a case of insomnia and arthritis/tendinitis in my knees. After my first session in the pod, I slept like a baby that night and my energy improved. After a few more sessions, my tendinitis improved during my training to the point that after a few weeks, my trainer said I looked night and day with the cuts I was able to make, and he was really impressed with my athletic ability without a lot of pain. The pod was a great experience in the end because of the improvements I felt in my body and the energy that I had on the field — and running around with my kids.”
Without understanding exactly what’s going on with the pod, the whole thing can feel a little bit like a futuristic tale, so I’ll explain in more detail. Let’s get technical for a second: Time in the CVAC pod makes mitochondria, which are powerhouses of the cell involved in ATP production, more robust, which hastens recovery from muscle injury, biogenesis of new cell growth, and lymphatic drainage and toxin removal. A CVAC session places a natural and tolerable stress on the body by dynamically cycling physical stressors like barostress (pressure), thermostress (temperature) and transient, pulsatile hypoxic stress by changing altitude. The body reacts to that stress by improving cellular function. This, in turn, enhances athletic performance and physical endurance. This same effect occurs during exercise, which can be accompanied by muscle tearing, joint stress, and lactic acid buildup, except CVAC sessions are much easier on the body, and allow an athlete to continue to improve energy production on the days he or she needs to rest to avoid overtraining, according to CVAC founder Carl Linton.
The ability to work out and rest simultaneously is ideal for working through an injury. The pod was instrumental in my work with pro boxer and Rocky Balboa star Antonio Tarver, with whom I used the CVAC pod to help facilitate recovery from a fractured thumb. His regular physician referred him to me for treatments during his recovery period. After several treatments with the pod, Antonio’s X-rays showed accelerated recovery, and his healing time was markedly reduced.
“The CVAC pod’s high-altitude simulator mechanism allowed me to maintain effortless physical conditioning since I couldn’t actively train,” Tarver said, “which allowed me to be victorious in my last fight, complete with a KO in the 7th round.” I couldn’t have been more thrilled to help him achieve it.
While it’s a new technology, the CVAC pod has been shown in early studies to be just as useful as we’ve experienced in my practice. Pilot studies have demonstrated a consistent increase in VO2 max — a measure of the maximum volume of oxygen that an athlete can use — in athletes whose only change in training regimen has been to introduce CVAC sessions. Specifically, in a study at the University of Hawaii, young elite athletes received CVAC Process exposures for eight weeks. After only 40 hours of CVAC exposure, the athletes experienced on average a 5.2 percent increase in VO2 max.
Likewise, an unpublished pilot study out of Stanford University demonstrated the results of four young elite athletes who experienced, at altitude, a 20-percent increase in peak power, a 12-percent increase in blood oxygen saturation, and an 11-percent increase in cardiac output. A validation study performed at the University of Hawaii demonstrated that the challenge created through the transient episodes of lowered oxygen may be the reason CVAC allows the body to become more efficient at utilizing available oxygen.
Closer to home, these studies all match up with my patients’ personal experiences. “Regarding athletic performance, I have thrown over 75 innings the past year with very minimal soreness following each outing,” Jim Kearschner, a patient and Men’s Senior League Baseball Fall Classic Champion, told me. “I have used the CVAC pod before and after games with great results — it helps reduce inflammation in my joints. As a result of great sleep, I have been able to function at high levels and with increased clarity and awareness.”
Athletes aren’t the only ones who can benefit from use of the CVAC pod. Anyone can, especially the deconditioned, and those with certain medical conditions such as diabetes and fibromyalgia. People with obesity, chronic pain, and amputations can have a very difficult time exercising, but CVAC provides the necessary controlled stress that exercise provides to result in cellular and mitochondrial and metabolic efficiency, without the muscle tearing, joint stress, or metabolic waste accumulation found after typical exercise. I have even found CVAC beneficial for patients with asthma and allergies. In fact, it would seem CVAC is well tolerated by just about everybody, from children to the elderly, and there are no contraindications. Additionally, recent evidence shows that the pod may be very beneficial in concussion injuries.
While the pod may look a little intimidating and otherworldly, CVAC technology has been identified as having no significant risk to people by numerous Human Research Protection programs at top universities, including Stanford, UC San Diego, Florida State University, and the University of Hawaii. I really believe that anyone and everyone can use the CVAC pod and gain benefit from it. I call it physical and spiritual reawakening and conditioning — it feels like a dance in the air! Personally, it has improved my sleep and energy levels, and all three of my active boys (ages 5, 7, and 9) use it to improve their athletic performance and recover from muscle overuse during sports. The CVAC is a truly phenomenal tool in my practice, in my own life, and in the larger athletic community.