Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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One Billion Dollars! O Valeant! Sung to tune of O Canada!

One Billion Dollars! O Valeant! Sung to tune of O Canada! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Shortly after the FDA approved Addyi (the "pink pill"), Canadian pharma company Valeant announced it would buy Sprout for $1 billion. Was it a good buy?


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Pharma Guy's insight:

Will Addyi survive in the market long enough for Valeant to recoup its costs?

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Viagra or Addyi: Which Sexy TV Ad Will Reign Supreme with Guys?

Viagra or Addyi: Which Sexy TV Ad Will Reign Supreme with Guys? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If you are half the man you claim to be, you no doubt have NOT skipped over the new Viagra TV ads, which feature a sexy woman  telling you not to worry about your erectile dysfunction – it’s more common than you think. Just pop a Viagra pill and you’re ready to go. Meanwhile, she’ll be waiting for you for a happy ending.

Soon, however, these Pfizer full bore sex ads will have competition from Sprout Pharmaceuticals, a small drug company located in Raleigh, NC.

As many media stories proclaim, Sprout Pharmaceuticals is a drug company with a potentially very big drug – “the world’s first pill to boost women’s sex drive.” It’s called Addyi (pronounced “addie”), which, according to Sprout CEO Cindy Whitehead (shown here holding Addyi pills in her hand), is “our representation of Everywoman,” whatever that means!

The FDA will soon announce whether or not it has approved Addyi, which the company plans to market as the “little pink pill.” The agency has rejected the drug twice in the past five years because of questions about its safety and effectiveness. 

According to this media story, Whitehead assures that “Addyi is not meant to be prescribed to women looking for a little extra pizazz, or women who are bored with their husbands.” Yeah, right.

Sprout is said to have promised the FDA that it won’t run TV ads for 18 months. What will it do before then to market the drug, if approved. And what will those TV ads look like?


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FDA to Hold Workshop on Developing Drugs for Female Sex Problems

FDA to Hold Workshop on Developing Drugs for Female Sex Problems | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In response to criticism that the FDA harbors a gender bias, agency officials have scheduled a two-day workshop in October to discuss female sexual dysfunction and ideas for developing appropriate drugs.


The move, which was announced this week on the FDA website, comes amid ongoing controversy over claims by some consumer advocacy groups and drug makers that the agency has failed to approve medications to combat female sexual problems. At the same time, they argue that nearly two dozen such treatments exist for men.


To press their case, the consumer groups and drug makers – including Sprout Pharmaceuticals, which is seeking FDA approval for a female sexual dysfunction drug – formed a coalition called Even The Score, created an online petition to generate public support and enlisted several members of Congress, who earlier this year met with FDA officials to press the issue.


There is considerable debate over the number of drugs available to treat male and female sexual dysfunction. Even The Score, for instance, tallies two dozen drugs for male sexual problems by citing different dosages or formulations of some medicines, as well as others such as testosterone treatments, which have not been approved specifically for combating sexual dysfunction in men. The FDA says only a few drugs have been approved for this use, actually.

Pharma Guy's insight:


Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo."

I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation:


"Study 511.147 was a randomized, placebo-controlled trial in which nearly 1,100 pre-menopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100 mg once daily at bedtime or placebo for 24 weeks. Co-primary end points were the change from baseline to study end in number of satisfying sexual events and increases in desire as measured by the Female Sexual Function Index (FSFI) desire domain score. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, and the FSDS-R Item 13 score, which measures distress associated with low desire on FSDS. Further, clinical meaningfulness of outcomes was assessed using the FDA recommended Patient Global Index of Improvement (PGI-I)."


"All endpoints achieved statistical significance," claim the authors. It may be statistically significant, but is it SEXUALLY significant?

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Flibanserin (Addyi): The Title IX of Drugs or the Pill for No ill?

Flibanserin (Addyi): The Title IX of Drugs or the Pill for No ill? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Since a Food and Drug Administration (FDA) advisory committee, on June 4, recommended approval of flibanserin (AddyiTM), there have been numerous editorials and news stories about the controversies surrounding the first “pink Viagra” poised to hit the market. Here, we seek to understand the process and financial incentives that led the advisory committee to recommend its approval. If approved by the FDA,  Sprout Pharmaceuticals will heavily market it as a treatment for a new disorder in DSM 5: Female sexual interest/arousal disorder.


Flibanserin, a serotonergic drug, was initially in clinical trials as an antidepressant. Despite its history of being a "thrice failed antidepressant," Sprout persevered and used the “finding” that some women in the drug trials said they experienced a slight increase in sexual desire as the reason to repackage the drug. Flibanserin was soon in clinical trials for Hypoactive Sexual Desire Disorder (HSDD), an indication listed in the previous edition of the Diagnostic and Statistical Manual of Mental Disorders)Sprout now maintains that HSDD is comparable to the DSM-5’s “Female Sexual Interest/Arousal Disorder,” and that women deserve a drug to treat this disorder.


As part of the attempt to gain approval for its drug, Sprout  initiated an ingenious marketing campaign, “Even the Score,” claiming that there was a sexism inherent in the number of FDA-approved treatments for sexual disorders: 26 for men and “zero for women.” However, this claim was false. There are only 8 drugs that treat male sexual dysfunction, and none are FDA-approved for low libido.


However, the “Even the Score” campaign worked. Sprout was able to get women’s groups to sign on to the idea that getting this drug approved was almost akin to getting Title IX passed. Not surprisingly, Sprout and its marketing tactics have come under fire. Although it is easy to vilify Big Pharma or one drug manufacturer, in order to effect real change it is necessary to uncover the complex system that led the advisory committee recommend that flibanserin be approved for marketing.

Pharma Guy's insight:

Sprout is said to have promised the FDA that it won’t run Addyi TV ads for 18 months. What will it do before then to market the drug, if approved? And what will those TV ads look like? Find out here: http://bit.ly/1K2vkX8 

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Will FDA Approval the "Pink Pill" Now That Peggy Hamburg Isn't Commissioner?

Will FDA Approval the "Pink Pill" Now That Peggy Hamburg Isn't Commissioner? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It's been in the works for years: a pill to help women with low sex drives. Women who've tested it love it. So, why hasn't it been approved? CBS 2's Erin Kennedy explores the controversy.


Amanda Parrish, a busy working mother of four, says sex was often the last thing on her mind.


“It got to where I’d be one of those women who would try to maybe be asleep before he got to bed,” Parrish said.


Her doctor diagnosed HSDD or hypoactive sexual desire disorder.

The prescription: enter a clinical trial of flibanserin, a little pink pill designed to boost a woman’s low libido.


Amanda got results.


“At the end of a long day even if I had worked and even if I had gotten the kids fed there was a desire there that previously had not been there,” she said.


“It actually balances out dopamine and serotonin so that women have more sexual thoughts, more fantasies,” said Northwestern Medicine’s Dr. Lauren Streicher, describing how it works in the brain.


So, if flibanserin worked for Amanda and 45 percent of women in the studies, why has it been rejected twice by the FDA?


Experts noted it didn’t work much better than a placebo and others say therapy, not a drug, should be the first choice for busy, stressed-out women.


Outspoken critics, like Dr. Adriane Fugh-Berman, director of Georgetown University’s research project PharmedOut, are also concerned about side effects.


“15 percent of the women in flibanserin trials dropped out because of side effects of sedation and nausea and fatigue,” Dr. Fugh-Berman.


“It’s my hope that the FDA approves it. I’ll be the first in line to get it,” said Amanda Parrish.


Earlier this year, Sprout Pharmaceuticals, which makes flibanserin, submitted new research on the pill’s impact on driving ability to the FDA. Those results showed no adverse effect.


The FDA holds another hearing concerning the pink pill’s approval next month.

Pharma Guy's insight:


A coalition of consumer advocacy groups and drug makers launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claimed that there are more than two dozen drugs available to help men combat sexual problems, but none for women. Is FDA sexist? Read more: http://sco.lt/6zDjUn

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Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems

Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Is the FDA guilty of gender bias? A coalition of consumer advocacy groups and drug makers recently launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claims that there are more than two dozen drugs available to help men combat sexual problems, but none for women.


A key backer is Sprout Pharmaceuticals, a privately held drug maker that has been haggling with the FDA over approval of its flibanserin treatment. The drug was once owned by Boehringer Ingelheim, but later sold to Sprout after an FDA rejection. Last fall, the agency rejected the pill again and Sprout responded in December by taking the rare step of filing an appeal, even though such efforts often go nowhere.

Pharma Guy's insight:


Boehringer gave up on flibanserin -- so-called "Female Viagra" -- after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.

Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. By the way, a "satisfying sex act" can include ... wait for it ... masturbation!


Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo."

I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation.


Read more about that here: Lack Sexual Desire? Try, Try Again!

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