Maker of ‘Female Viagra’ Sued as Sales Fizzle

Health Letter, June 2017

By Sarah Sorscher, J.D., M.P.H.

Flibanserin (ADDYI) was billed as the “female Viagra” because it was intended to increase sexual desire in women with “hypoactive sexual desire disorder,” or low interest in sex. Following the Food and Drug Administration’s (FDA’s) approval of the drug in August 2015,[1] Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, called the decision a “big mistake” and predicted that the drug would be off the market soon.[2]

Now, this prediction appears close to coming true, though not through any effort by the FDA to withdraw the drug. Sales of flibanserin have failed to meet expectations.[3] Stocks in Valeant, the drug’s troubled owner, have plunged 97 percent since that company purchased the drug’s developer, Sprout Pharmaceuticals, for a whopping $1 billion a year and a half ago.[4],[5]

Last November, former shareholders in Sprout initiated a lawsuit against Valeant, accusing the company of bungling sales efforts by hiking up the price of flibanserin and failing to adequately invest in marketing.[6]

Flibanserin’s failure was predictable, given the poor performance of the drug in clinical testing. Women using the drug had, at best, an average of only one more “satisfying sexual encounter” every month than those using a placebo.[7] Meanwhile, the drug carried serious risks, including low blood pressure and fainting, particularly when alcohol was also consumed.[8]

The FDA had rejected flibanserin in 2010 and 2013. After the 2013 rejection, Sprout Pharmaceuticals initiated an aggressive lobbying and public relations campaign, accusing the FDA of imposing an unfair double standard on drugs intended for female, as opposed to male, sexual disorders.[9]

The FDA eventually succumbed to pressure and approved the drug but required a black-box warning in the product labeling advising women not to use alcohol when taking the drug, as well as special training for doctors and pharmacists who prescribe or dispense the drug.[10] In another key restriction, the company pledged not to run any advertisements targeted at patients for 18 months after the drug’s approval.[11]

Following approval, Valeant did little to make this uninspiring drug more appealing. After purchasing flibanserin, Valeant doubled its price and required purchases to be made through a single mail-order pharmacy, Philidor Rx Services.[12] This move reflected Valeant’s business strategy, which involved buying up older drugs with a well-established market and then jacking up prices, gouging hospitals and other payers and thus restricting access for desperate patients dependent on the drugs.[13]

But Valeant was unprepared to market a new drug like flibanserin. It failed to provide its marketing team with many standard sales tools, such as wall posters and brochures. Then, in April 2016, Valeant dismissed the entire flibanserin sales force, promising a new marketing launch in the future.[14]

Meanwhile, Valeant was being rocked by larger scandals. In the months leading up to flibanserin’s product launch in October 2015,[15] the company was under investigation by Congress and federal prosecutors for its predatory drug-pricing practices.[16] Then, just days after the launch, Valeant was accused of using Philidor Rx Services to fraudulently inflate sales, forcing the company to cut ties with the pharmacy and leaving flibanserin without a distributor.[17],[18]

Valeant had expected the “female Viagra” to be a blockbuster, earning back its $1 billion purchase price in just a few months as a flood of women sought treatment with the new drug.[19] Instead, sales came in at a trickle, forcing the company to adjust expectations dramatically.[20] Sales for 2016 totaled an abysmal $10 million by November of that year.[21]

Many insurers have declined to cover flibanserin, and others have discouraged use by requiring women to visit a psychiatrist before taking the drug[22] or by requiring higher co-pays from patients.[23] In March 2016, Valeant reported that only about 60 percent of prescriptions written for flibanserin were actually being filled and paid for.[24]

The recent shareholder lawsuit may be the final nail in the coffin for a drug that should never have been approved. Yet the ADDYI website remains active, and the ban on consumer-targeted advertising expired in February, opening up new possibilities for Valeant, or another company, to relaunch the drug. Unless the FDA acts to require the drug’s withdrawal, flibanserin could still receive a second life, putting more patients at risk from this quite dangerous but largely ineffective drug.


References

[1] Food and Drug Administration. FDA approves first treatment for sexual desire disorder. August 18, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm. Accessed February 13, 2017.

[2] Public Citizen. FDA’s big mistake: Expect flibanserin to be pulled from the market in a few years. August 19, 2015. https://www.citizen.org/media/press-releases/fda%E2%80%99s-big-mistake-expect-flibanserin-be-pulled-market-few-years#overlay-context=home. Accessed February 13, 2016.

[3] McCullough M. Lawsuit: Valeant is letting ‘female Viagra’ sales sag. Philly.com. December 29, 2016. http://www.philly.com/philly/health/womenshealth/Lawsuit-Valeant-is-letting-female-Viagra-sales-sag.html. Accessed February 13, 2017.

[4] Ibid.

[5] Thomas K, Morgenson G. The female Viagra, undone by a drug maker’s dysfunction. New York Times. April 9, 2016. https://www.nytimes.com/2016/04/10/business/female-viagra-addyi-valeant-dysfunction.html. Accessed February 13, 2017.

[6] McCullough M. Lawsuit: Valeant is letting ‘female Viagra’ sales sag. Philly.com. December 29, 2016. http://www.philly.com/philly/health/womenshealth/Lawsuit-Valeant-is-letting-female-Viagra-sales-sag.html. Accessed February 13, 2017.

[7] Public Citizen. FDA’s big mistake: Expect flibanserin to be pulled from the market in a few years. August 19, 2015. https://www.citizen.org/media/press-releases/fda%E2%80%99s-big-mistake-expect-flibanserin-be-pulled-market-few-years#overlay-context=home. Accessed February 13, 2016.

[8] Ibid.

[9] Thomas K, Morgenson G. The female Viagra, undone by a drug maker’s dysfunction. New York Times. April 9, 2016. https://www.nytimes.com/2016/04/10/business/female-viagra-addyi-valeant-dysfunction.html. Accessed February 13, 2017.

[10] Ibid.

[11] Ibid.

[12] Ibid.

[13] Pollack A. Valeant under investigation for its drug prices practices. New York Times. October 14, 2015. https://www.nytimes.com/2015/10/15/business/valeant-under-investigation-for-its-drug-pricing-practices.html. Accessed February 13, 2017.

[14] Thomas K, Morgenson G. The female Viagra, undone by a drug maker’s dysfunction. New York Times. April 9, 2016. https://www.nytimes.com/2016/04/10/business/female-viagra-addyi-valeant-dysfunction.html. Accessed February 13, 2017.

[15] McCullough M. Lawsuit: Valeant is letting ‘female Viagra’ sales sag. Philly.com. December 29, 2016. http://www.philly.com/philly/health/womenshealth/Lawsuit-Valeant-is-letting-female-Viagra-sales-sag.html. Accessed February 13, 2017.

[16] Pollack A. Valeant under investigation for its drug prices practices. New York Times. October 14, 2015. https://www.nytimes.com/2015/10/15/business/valeant-under-investigation-for-its-drug-pricing-practices.html. Accessed February 13, 2017.

[17] Reuters. Valeant is being sued over the ‘female viagra’ pill. Fortune. November 2, 2016. http://fortune.com/2016/11/02/valeant-pharmaceuticals-female- libido-pill/. Accessed February 13, 2017.

[18] Thomas K, Morgenson G. The female Viagra, undone by a drug maker’s dysfunction. New York Times. April 9, 2016. https://www.nytimes.com/2016/04/10/business/female- viagra-addyi-valeant-dysfunction.html. Accessed February 13, 2017.

[19] Silverman E. Valeant cutting sales reps for female libido pill. STAT. April 4, 2016. https://www.statnews.com/pharmalot/2016/04/04/valeant-addyi-sales-reps/. Accessed February 13, 2017.

[20] Ibid.

[21] Reuters. Valeant is being sued over the ‘female viagra’ pill. Fortune. November 2, 2016. http://fortune.com/2016/11/02/valeant-pharmaceuticals-female- libido-pill/. Accessed February 13, 2017.

[22] Cohen E. Insurance won’t pay for women to have pleasurable sex. CNN. June 29, 2016. http://www.cnn.com/2016/06/29/health/female-sex-drugs/. Accessed February 13, 2017.

[23] Koons C. The trouble with female libido pill is a symptom of Valeant woes. Bloomberg. March 17, 2016. https://www.bloomberg.com/news/articles/2016-03-17/the-trouble-with-female-libido-pill-is-a-symptom-of-valeant-woes. Accessed February 13, 2017.

[24] Ibid.