San Diego firms Apricus, Innovus tackle male and female sex problems

Not yet approved solutions

Roy Moynihan’s book details pharmaceutical companies’ plans to push the idea of female sexual dysfunction all the way to the bank.
  • Roy Moynihan’s book details pharmaceutical companies’ plans to push the idea of female sexual dysfunction all the way to the bank.

In December, a small local biotech named Apricus Biosciences decided to put substantially all its eggs in one basket: male and female sexual disorders. But in tackling male erectile dysfunction, Apricus faces stiff competition from pharmaceutical giants Eli Lilly (Cialis), Pfizer (Viagra), and Bayer (Levitra). Trying to relieve female sexual dysfunction presents a completely different problem: many critics think this so-called disorder, although officially recognized by the American Psychiatric Association, is an industry marketing ploy to peddle potions of dubious value.

Apricus is trying to get regulatory approval around the world for Vitaros, a topical treatment that, spread on the penis, is supposed to bring an erection faster than competitors’ products. It supposedly works well with men who don’t respond to Viagra, but it has only been approved in Canada.

Erectile dysfunction is a market of close to $5 billion. Two years ago, Cialis passed the originator, Viagra, in sales, greatly because it boasts of a high-powered drug that can be effective for up to 36 hours. In France, it’s called “le weekender.”

In the United States, the Food and Drug Administration has never given the okay to any medical treatment for female sexual dysfunction, which comes in several varieties: sexual arousal disorder (the one Apricus is going after), orgasmic disorder, sexual aversion disorder, sexual pain disorder, hypoactive sexual desire disorder, and some other medically related conditions. Powerful companies, such as Procter & Gamble and Germany’s Boehringer Ingelheim, have flopped trying to exploit this field.

But Apricus thinks there can be a $4 billion market and believes its Femprox, meant to create clitoral enlargement, can be among the successful treatments.

“Female sexual dysfunction is a real disease,” says Dr. Bassam Damaj of La Jolla’s Innovus pharmaceuticals.

“Female sexual dysfunction is a real disease,” says Dr. Bassam Damaj of La Jolla’s Innovus pharmaceuticals.

Sexual dysfunction in women, says Edward Cox, vice president of Apricus Biosciences, “is indeed a complex, multi-factoral condition.”

Sexual dysfunction in women, says Edward Cox, vice president of Apricus Biosciences, “is indeed a complex, multi-factoral condition.”

Last November, Apricus’s chief executive, Dr. Bassam Damaj, left the company for undisclosed reasons. In January, Damaj became chief executive of Innovus Pharmaceuticals, which then moved to La Jolla. Damaj is loaning Innovus half a million dollars to fund product development, including treatments for female sexual dysfunction. The company is in negotiations to acquire a topical over-the-counter product that would increase blood flow to the clitoris, says Damaj. Innovus bought the non-American rights to an over-the-counter product, CIRCUMserum, that increases sensitivity of the penis. (It doesn’t cause erections but makes them more fun.)

Just think: we used to call men impotent and women frigid. Now their bedroom shortcomings have fancy medical names and supposed cures.

Treatments for erectile dysfunction are generally satisfactory. But controversy rages over female sexual dysfunction. A 2010 book by Ray Moynihan and Barbara Mintzes, Sex, Lies & Pharmaceuticals: How Drug Companies Plan to Profit from Female Sexual Dysfunction, opened some eyes. “Women’s sexual difficulties are being repackaged as symptoms of a new disorder,” say the authors, flagellating the “marketing machine” that plans to exploit a condition that is highly complex physically, psychologically, and interpersonally and may not respond to the expensive treatments. To hawk sales, pharmaceutical companies have come up with diagnostic tests “aimed at measuring disorders that may not in fact even exist,” says Moynihan.

In Psychology Today last month, Dr. Allen Frances, an emeritus professor at Duke, slammed “disease mongering of female sexual disorders.” Female sexual dysfunction is “mostly a concoction of lusty males, sex disorder clinicians and researchers (mostly male), and drug company sales gurus,” wrote Frances.

He quoted Tamara Kayali, a postdoctoral researcher at Dalhousie University in Nova Scotia, who wrote that “previously proffered products all turned out to be ineffective duds, but as the female sexual disorders represent such marketing gold, the companies keep coming up with new contenders and new hype that women have a sexual disorder that needs treatment.” She pointed out that if a woman is disinterested in sex or doesn’t find it enjoyable, “the problem may not be a biological or mental illness. Perhaps the relationship needs some adjustment or her man needs some skills training.”

Perceptively, she cited one American study that showed that 29 percent of women said they “usually” or “always” experience an orgasm during sex, while more than twice as many, or 60 percent, reported having an orgasm from masturbation. The problem may be that too many men are lousy lovers. Said Kayali, “So while it may be kind of scientists to attempt to develop a drug that enables women to gain more pleasure and satisfaction from sex, it would be even kinder to women to look into a drug that made men better at it.”

The Mayo Clinic notes that women’s sexual problems may result from physical conditions such as arthritis, urinary and bowel difficulties, pelvic surgery, and — yes — headaches. Postmenopausal changes can weaken the sex drive, as can depression, anxiety, heart and blood-pressure diseases, and liver or kidney failure. Drugs such as antidepressants and antihistamines can decrease sexual desire and response.

The Harvard Medical School notes that a man’s erection is a quantifiable event, “but a woman’s sexual response is qualitative… it can’t be measured objectively. Without an empirical standard by which to assess female sexual function, it would seem difficult, if not impossible, to come up with criteria for female sexual dysfunction.”

Damaj of Innovus disagrees with the critics: “Female sexual dysfunction is a real disease,” he says. The market for it “is estimated to be larger than the male erectile dysfunction market.” Edward Cox, Apricus’s vice president of corporate development, says female sexual dysfunction “is indeed a complex, multi-factoral condition with anatomical, physiological, medical, and psychological components. [But] significant numbers of American women — up to 40 million, by some estimates — are turning to their physicians seeking a medical solution.”

Financially, both companies are troubled. Apricus lost $31.7 million last year, worse than the $18.1 million loss of 2011. The cumulative loss since the company’s inception is a stunning $251.2 million. The stock hit $294.39 in 2000 but Monday closed at $2.89. Innovus, which does not yet have a listing on Nasdaq, has never had revenue from a product. The stock closed Monday at 46 cents.

Bottom line: attacking sexual dysfunction can be dyspeptic.

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Murphyjunk: I worked on that column for a long time, and that never occurred to me. But let me prick your balloon: the company was named Apricus before it tackled the erectile dysfunction market. Best, Don Bauder

Don Bauder Actually, that's not true. The company changed it's name from NexMed, Inc. to Apricus barely 2 months before Canada gave approval for Vitaros, which obviously they had been working on for somewhat longer than 2 months. After operating as NexMed for 15 yrs, they change their name to A pric us just 2 months before gaining approval on their prick response drug and it's just pure coincidence? I don't know. Sounds suspicious to me. Perhaps you need to do a little hard investigating on this one. I do hope my comment doesn't rub you the wrong way.

tomjohnston: I don't disagree that it sounds suspicious -- Freudian, really. There could be other explanations. The drug delivery system the company boasts about is called NexACT. This may explain the former corporate name NexMed. Also, the company had oncology products. Apricus may have been a play on apricot. Apricot pits have been used in cancer treatments, among other things. Interesting. Best, Don Bauder

Don Bauder, You ARE old aren't you!!!??? FYI: A pric us, hard investigating, rub you the wrong way, prick response drug. Play on words, humor, pun, jocularity, double entendre. etc, etc, etc.

tomjohnston: Yes, I am old (77 next month), but thus far I am the only one among blog responders who realized that the name of the person interviewed at Apricus is Cox. How could you young folks have missed that? Best, Don Bauder

Well, maybe it's just that sometimes the obvious isn't nearly as funny as the veiled.

tomjohnston: Or it could be my advancing senescence. Best, Don Bauder

Advancing senescence; isn't that kind of redundant?

tomjohnston: You could look at advancing senescence as a contradiction in terms. On the other hand, some folks have onset dementia and others have advanced dementia. Frankly, I don't want either kind of senescence, but there isn't anything I can do about it. Best, Don Bauder

The timing of this story is a bit off. It should have appeared in the same issues that mentioned the free vibrator giveaway.

aardvark: I thought everybody would have forgotten the free vibrator giveaways by the time this ran. The last of the vibrator articles ran March 27 -- nearly a lifetime ago. Best, Don Bauder

Don--are you kidding? I (and others) had more fun with that story--there are a few stories that just "stand out".

aardvark: Yes, some stories have a certain buzz to them -- tickle the funny bone, so to speak. Best, Don Bauder

And I hesitate to "bring this up", but Bassam Damaj equates to "Madam Jab Ass". Coincidence?

H. Baudy: And Innovus is nuvo sin, as in groundbreaking, innovative ways to...oh, never mind. Best, Don Bauder

aardvark: Do you realize that aardvark rhymes with card shark? Best, Don Bauder

Wikipedia says the interim CEO is Steve Martin! A "wild and crazy guy" is running the company while playing the banjo and doing magic tricks? ;-) Also, I'm guessing it's pronounced APP-ri-cus, not "A pric us."

dwbat: Steve Martin -- not the comic -- was interim CEO. Now he is chief financial officer and a fellow named Richard Pascoe has been named CEO. The company is pronounced APP-ri-cus. This should at least slightly puncture the concupiscence of the pric conspiracy theorists. Best, Don Bauder

I know it wasn't Steve Martin the actor. That was humor!

dwbat: And I caught the humor, even at my age. Best, Don Bauder

I posted your article on Facebook with the following comment:

Three cheers for Don Bauder! We can always count on him to pull back the curtains and reveal what's up. Or what's not…

Whether it's government or Wall Street or ??? -- lately everywhere you look, dysfunction seems to be the name of the game.

Norma: You're too kind -- and too clever for me. What's up? Well, the stock market is, thanks to the Federal Reserve's staggeringly easy money policy, and thanks to the weak economy that keeps inflation from exploding. You are so correct: dysfunction is ubiquitous. Best, Don Bauder

viewer: I don't know whose last 13 words, or last 9, you are alluding to -- mine or Norma's or somebody else's. Elaborate, please. Best, Don Bauder

viewer: Not only do I make mistakes, I confess them. If you are a reader, you will see "mea maxima culpa" from time to time when I am in the confessional, seeking forgiveness for an error. The words that you are alluding to are ones that I have written many times: the Fed's incredibly easy money policy will implode at some point, but inflation won't erupt now because the economy is so weak. I also said dysfunction is ubiquitous. I have been saying that for decades. Best, Don Bauder

viewer: Aw c'mon, viewer. I am admitting errors regularly. Where else do you read mea maxima culpa? Best, Don Bauder

"But in tackling male erectile dysfunction, Apricus faces stiff competition ..."

Et tu, Bauderus? Next you'll be quoting some critic of female sexual dysfunction who thinks the whole concept is "all wet."

Submariner: Confession: use of the word "stiff" was deliberate. Generally, though, I tried to sprinkle only a few metaphors into this column. Wagner used restraint in his use of leitmotifs. That's why he was always respectfully called Richard -- never Dick. Best, Don Bauder

viewer: Females have lots of disadvantages -- the glass ceiling for example -- but they do outlive males. Best, Don Bauder

viewer: In many cases, the female who outlives her spouse in age inherits his assets, including his financial accounts. Best, Don Bauder

viewer: Females are always outsmarting males. Haven't you figured this out yet? Best, Don Bauder

Poets might be more helpful than doctors in curing these problems. Tip: One should never whisper the word "dysfunction' in a woman's ear. Also: Abelard was so seriously challenged in a physical sense that Viagra wouldn't help him, yet even today, as we speak, he heats a woman somewhere to satisfaction. The Lizard knows.

Psycholizard: Abelard, the philosopher, with world-renowned knowledge and expertise in music, wound up a castrato as a result of his affair with Heloise. She ended up pregnant and then in a nunnery. Medicines for sexual dysfunction would have helped neither. Best, Don Bauder

I believe in science in most matters, but sometimes magic works best. I suspect the traditional cure for wives' sexual dysfunction, finding a boyfriend, will only gain popularity if these drugs work.

Psycholizard: Yours is a profound philosophical question. Will female dysfunction cures increase adultery? Or, possibly, decrease it? Of course, don't just hang this on the women: do Viagra, Cialis et al increase male infidelity? Decrease it? Has anybody done a study on that? Best, Don Bauder

"I believe in science in most matters, but sometimes magic works best." Apparently, sometimes a woman's "dysfunction" has nothing to do with the woman at all. Maybe a set of new batteries could also be a consideration. It's not just diamonds that are a girls best friend. Or at least so I've read.

tomjohnston: And you are very well read, as your posts attest. Best, Don Bauder

The Viagra ads should feature an unattractive older woman shrieking: "You married me for my daddy's money.". Pitch line; "Get Viagra or get a job.". Male sexual dysfunction is limited to married men, and other male sex workers, because other men have no obligation to perform, and therefore don't have a function to diss. Fact is, these are party drugs, they don't treat any true medical condition. Every charge leveled at illegal party drugs can be leveled at them, to some degree.

For the females, a prominent and tireless researcher of the 1930's reports, 'Candy is dandy, but liquor works quicker.". Sadly for Dorothy Parker Pharmaceuticals, the patent on ethyl alcohol expired before she could profit from her research.

Psycholizard: Ah, Dorothy Parker -- one of the great wits of the 20th century. I loved this Parker poem: "I like to have a martini, two at the very most, After three I'm under the table, after four I'm under my host." Best, Don Bauder

dwbat: She was an absolute genius. The New Yorker had so many then: Parker, Thurber, Woollcott...the list goes on and on. Best, Don Bauder

We should note that the snake oil salesmen of one hundred years ago actually had a alcoholic potion that might help a woman's love life. Today's snake oil salesmen just sell promises.

Some attribute my quote to Ogden Nash, but if memory serves, the New Yorker gives it to Parker, in the above form.

Psycholizard: Ogden Nash gets credit for candy is dandy but liquor is quicker. The one about snake oil salesmen sounds like Dorothy Parker, but I haven't been able to authenticate that. I only made a quick check. Best, Don Bauder

Oh, my, my, my--and all this time I thought it was Water Closet Fields who said that. Well, well, uhhh--one learns something every day.

Twister: Water Closet Fields was asked if he would like a glass of water. "Water??" he shouted "Fish fornicate in it." Although he didn't say "fornicate." Best, Don Bauder

Nash and Parker worked at the New Yorker at the same time. I remember it as Parker, the internet says Nash. it's a Parkerism regardless, in theme and form. The snake oil remark is a lizardism, the snakes are close cousins after all.

Psycholizard: So YOU are the originator of the snake oil line. Congratulations. Too bad you only use a pseudonym. When the quote gets into Bartlett's, your real name won't be on it. Best, Don Bauder

WAS THIS LINE PARKER'S? Maybe someone remembers this: back in Parker's time, some sharp-tongued female wit was making plans with a man to make some whoopee. But the lady faced a delay of some kind. She said to the fellow: "Go ahead. You can get started without me." Best, Don Bauder

viewer: I am not aware of any of your comments being deleted. But monitoring posts for possible deletions is not my job, so I can't say it didn't happen. Best, Don Bauder

Now we really want to read viewer's comment, in spite of it being non-profane.

Psycholizard: Do you suppose viewer's comment was deleted because it WAS non-profane? Nah.... Best, Don bauder

Roger N

Men don't seem to understand that women are aroused by massaging their brain, not their clitoris.

Roger: That's no doubt true of some women, but not others. If it were true in 100% of cases, dumbbells like me would be celibate. Best, Don Bauder

"If all the girls who attended the Yale Prom were laid end to end, I wouldn't be a bit surprised.". Dorothy Parker. I personally know nothing about women, except that some are lots of fun.

Psycholizard. That classic Parker line reminds me of one by the opera comedienne, Anna Russell. In her shtick, she was describing the Valkyries in Wagner's Die Walkure. She told how they wore leather helmets with horns on them, wore leather protective chests guards, carried the dead and injured soldiers to Valhalla. Then, said Russell, "Oh yes. They are all virgins. And I'm not a bit surprised." Best, Don Bauder

"I personally know nothing about women, except that some are lots of fun." Generally speaking, I have found that if I confine my knowledge of women to what my wife allows me to know, then my life is much simpler.

tomjohnston: That could work in many instances. My mother was smarter than my father and my wife is smarter than I am. But if it's the other way around, as it is in some families, then your philosophy might not work so well. Best, Don Bauder

Don Bauder, A few of thoughts. First, "knowledge of women", as Psycholizard calls it, and how smart you are, are two completely different things. And there isn't a man alive who "knows" all there is to know about women and any man claiming such is a liar....and single!!!LOL Second, any man who thinks he is smarter than his wife, and let's her know it, is a lot dumber than he thinks he is. And finally, the previous comment to which you replied, was pure, unadulterated tongue and cheek.

tomjohnston: Speaking as one who has been happily married for more than 50 years, I would say that the fellow who stays single because he thinks he knows women probably doesn't know the right women. There's an old saying: Love is blind and marriage is eye-opening. Best, Don Bauder

Don Bauder, A few more thoughts. Referring to a ''fellow who stays single'' connotes choice, at least to me. My meaning was someone single, though hardly by HIS choice. ''Knowing'' the right woman is purely subjective. There maybe many women he feels are the ''right'' one for him, but from their view, maybe not so much. My wife and I have been together since the fall of 1968. I would never even dream of thinking, let alone saying out loud that I know all there is to know about women in general or my wife specifically. She is a paradox, both enigmatic and revelatory at the same time. Even after all of this time, she can still have an air of mystery about her on occassion. She can still be unpredictable. Not in a capricious way, more like natural, transparent, spontaneity. Kind of like mystery and perspicacity all rolled into one. Why she's put up with me all these years, I don't know.

tomjohnston: Yes, some men remain single because women won't have anything to do with them. Consider a superbly-talented man who was the Lion of Vienna, celebrated worldwide, beloved of royalty who showered money on him. He wrote of his "immortal beloved" but remained a bachelor. Maybe she wasn't interested. Historians think the women were turned off because of his personal habits; anyone entering his home encountered month-old food lying around, crumbs everywhere, general dishevelment. His name was Ludwig Van Beethoven. Best, Don Bauder

And of course the societal doctrines of 2 centuries ago are so relevant today. In particular the class system and a woman's place in society at that time. LOL BTW, Quasi Una Fantasia was indeed written for his love, Countess Giulietta Guicciardi, who as I recall, was one of his young teenage students. I also seem to recall that her parents forbade her to marry Beethoven after his proposal, because he was not of their class.

tomjohnston: It is clear that Beethoven proposed to the young countess, one of his students, and that her father thought he wouldn't measure up. However, she was probably not Beethoven's immortal beloved. There are a couple of other candidates that historians rank higher than the countess, although she is on the list of possibles. Best, Don Bauder

Females of most species run the show. Just hang around, and when they finally decide to stop flirting and get down to business, leave. Then come back after a couple of weeks or a month's absence (or maybe as much as a year) and see if they are more or less interested. If they're glad to see you, carry through and see if they're ready. Then and only then let her draw you in and enjoy it. Show a little tenderness, but don't fawn, be strong, not mean, but don't take any abuse (this is testing your suitability). Don't be brutal, be brave. Darlin', I'll die for you, but I won't cry for you. If you want to leave, what we shared will always be with me . . .

Why aren't we hearing from women?

Twister. Surveys show that many women are not turned on by the macho male whom you described. Best, Don Bauder

This is not "macho." It is giving the woman space to do the deciding about your suitability. "Methods" don't work, at least in terms of mutual satisfaction, in its highest sense, a "peak experience."

Good grief! 67 replies and counting, and displacement activity (save maybe one post) continues to run rampant.

Yes, the brain is the most important sex organ, and it requires that special connection that no one knows anything about, and nothing more . . .

But for those who have allowed the "use it or lose it" syndrome to deflate their egos, etc., there is a gadget that can inflate it pretty well without medication. It fits over the thing, and one pumps it up and applies a tourniquet (which also has a clitoral stimulator attached). It's good for a maximum of 15 or 20 minutes before it becomes an elastorator.

For the gals, it's a matter of mind over peter--I have heard some women say that faking it can actually bring on a real orgasm. Feeback loop?

The main thing is to RELAX. Nothing like anxiety to #u(k up a good f)(k.

A man from my childhood gave me the best advice: "Don't never chase after women, son--just be ready. Timing is everything, and NOW is all there is to timing.

For some reason I'm reminded of the "old" movie where David Niven is "seducing" Ava Gardner (or was it Rita Hayworth?). He was loudly smooching up and down her arm and she asked "What are you doing?" "Preparing you!"

But all Nivenerna aside, a long, long, long, foreplay and teasing to raise the tension should be the largest part of the act. Well, just the right length, anyway. One time a bunch (maybe 20) of us (men and women) were sitting around the campfire passing a jug of whisky around the circle and shooting the $h!t, and some of the gals said, "Look, guys, SIZE is important!" When I, in my high state said, "Well, about three inches should be PLENTY, right?" Incredulous looks. "Well, we are talking DIAMETER, right?"

Twister. In real life, from what I have read, no one had to seduce Ava Gardner. She was always ready, according to legend, anyway. Best, Don Bauder

Egad, had I only known! The two top movie stars I wanted to #)^k with were Ava and Lena.

Now, it would be Marisa, and there are no other contenders.

PS: And it has relatively little to do with looks; one of the women I loved the best had a face like a horse's. Another was as round as a beach-ball--she had the best technique of all and she liked to bang, bang, bang!

viewer: Some women marry men for their money. On the other hand, some men marry women for THEIR money. It goes both ways. Best, Don Bauder

And sometimes a man and a women marry and make their own money.

tomjohnston: If a man and a woman can marry, and make both lots of money and whoopee, that is a recipe for a successful marriage. Best, Don Bauder

Don Bauder, 37 yrs as of May15th. Lot's of money, but way more "whoopee". LOL

Viewer. For someone with the appellation "viewer," you seem to be blind. Best, Don Bauder

tomjohnston: My congratulations to you -- more whoopee than money. You have your priorities straight. Best, Don Bauder

viewer: The younger the woman, the more scandalous? As a generalization, perhaps yes, but Mae West kept generating scandal right into the grave. Best, Don Bauder

And well beyond, in legend, anyway.

Duhbya. Mmaybe her ghost writers continued cranking out prose even after she was no longer around to participate in the fun. Best, DonBauder

Duhbya. What a grand lady she was. She had a life preserver named after her. One of her lovers was an African American champion prizefighter. The apartment building she lived in complained. She solved the problem by buying the building. Best, Don Bauder

I heartily agree. Lest we not forget her often misquoted line "Why don't ya come up and see me sometime", here's the real deal. They don't make 'em like that anymore.

From what I've read, Paramount owned The Ravenswood (http://www.cpmusa.com/Ravenswod.htm), and West (and other stars) were provided temporary apartments there. West apparently stayed on and had a lifetime lease.


by dwbat

Mae West had zero sex appeal from my standpoint. My grandpa would say, "What that woman needs is a good dunk in the rain barrel!" I prefer my women real.

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