{"id":8514,"date":"2015-09-10T15:46:47","date_gmt":"2015-09-10T15:46:47","guid":{"rendered":"http:\/\/www.edrugstore.md\/blog\/?p=8514"},"modified":"2015-09-10T18:03:07","modified_gmt":"2015-09-10T18:03:07","slug":"female-viagra-company-bought-for-1-billion","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/female-viagra-company-bought-for-1-billion\/","title":{"rendered":"Female Viagra Company Bought for $1 Billion"},"content":{"rendered":"
\"With
With the FDA’s conditional approval of flibanserin, women now have a drug to help them fire up their libido.<\/figcaption><\/figure>\n

For tiny Sprout Pharmaceuticals, it was quite a week! On Tuesday, August 18, 2015, the U.S. Food and Drug Administration gave the company\u2019s only drug a conditional go-ahead, and barely two days later the North Carolina-based company announced that it was being acquired for a cool $1 billion by Valeant. Valeant\u2019s move to acquire Sprout is seen by many observers as a solid vote of confidence in the long-term outlook for flibanserin, the first FDA-approved drug for the treatment of female sexual dysfunction.<\/p>\n

Not a bad week at all for a company that didn\u2019t really exist until about five years ago. In fact, Sprout was cofounded by the husband-and-wife team of Cindy and Robert Whitehead for the express purpose of winning FDA approval for a prescription drug that could help women deal with hypoactive sexual desire disorder, or HSDD. The disorder (decreased sexual desire) is the most common form of sexual dysfunction among women. Unlike sexual dysfunction in men, which most often involves blood flow to the genitals, women\u2019s biggest sexual problems can often be traced to an imbalance in brain chemistry.<\/p>\n

Prior to founding Sprout, the Whiteheads were both top executives at Slate Pharmaceuticals, which developed and marketed an implantable testosterone replacement therapy system known as Testopel.<\/p>\n

Origins of Flibanserin<\/b><\/p>\n

Flibanserin was first developed by German pharmaceuticals giant Boehringer Ingelheim, which in 2010 submitted a new drug application to the FDA in hopes of marketing the drug as a treatment for HSDD. Later that year, the FDA rejected Boehringer\u2019s application, and not long thereafter the company decided to abandon its campaign on behalf of flibanserin, the patent to which was acquired by Sprout in 2011.<\/p>\n

Winning FDA approval for the drug did not come easily, but Sprout proved that it was more than equal to the task despite its relatively small size. Now that the heavy lifting has been done, Valeant Pharmaceuticals has acquired Sprout and Sprout\u2019s biggest asset, flibanserin, which is scheduled to be marketed as Addyi. Current projections indicate it will come to market sometime during the fourth quarter of 2015.<\/p>\n

Many Obstacles Overcome<\/b><\/p>\n

In a recent interview with <\/span>Business Insider<\/a>, Cindy Whitehead, Sprout\u2019s chief executive officer, talked frankly about some of the obstacles that had to be overcome to win FDA approval for flibanserin. She also shared her thoughts about the importance of bringing a drug to market that offers hope for women who have lost their interest in and desire for sex.<\/p>\n

\"For
For women, the most common form of sexual dysfunction is a loss of interest in and desire for sex.<\/figcaption><\/figure>\n

\u201cI think the possibility of offering women access to a treatment really meant a lot to me,\u201d Whitehead told Business Insider, noting that since Viagra\u2019s 1998 introduction the FDA has approved 27 drugs for male sexual dysfunction and, until August 18, 2015, none for women.<\/p>\n

Unlike Boehringer Ingelheim, which walked away from flibanserin after the FDA\u2019s rejection in the fall of 2010, Sprout refused to give up on the drug. To prepare its application for the drug\u2019s approval, Sprout conducted studies that it hoped would answer some of the safety concerns cited by the FDA in rejecting Boehringer\u2019s application.<\/p>\n

Flibanserin Resubmitted in 2013<\/b><\/p>\n

With the results of those studies accompanying its application, Sprout in June 2013 once again petitioned the drug regulatory agency for permission to market flibanserin. However, the FDA rejected Sprout\u2019s application, again saying that the drug\u2019s risks outweigh its modest benefits and also citing concerns about flibanserin\u2019s long-term effects. The agency also requested an additional study to determine flibanserin\u2019s potential drug interactions with other medications and a driving study to see if flibanserin is likely to cause sleepiness for women behind the wheel.<\/p>\n

Still stinging from the FDA\u2019s latest rejection, Sprout in December 2013 appealed the FDA decision and filed a request for a formal dispute resolution with FDA\u2019s Office of New Drugs. In support of Sprout\u2019s appeal, the International Society for the Study of Women\u2019s Sexual Health sent the regulatory agency a petition with 4,000 signatures urging approval of flibanserin. In response, the FDA offered detailed guidelines that Sprout might choose to follow to win approval of the drug.<\/p>\n

Proponents, Foes Rally Forces<\/b><\/p>\n

Much of the spring of 2014 was devoted to a mustering of forces, both pro and con, on the issue of flibanserin. In April, Janet Woodcock, M.D., director of the FDA\u2019s Center for Drug Evaluation and Research, received a letter from a group of women\u2019s health organizations urging FDA rejection of the drug on the grounds that its risks outweigh its benefits.<\/p>\n

Two months later, with Sprout\u2019s backing, a coalition of 24 women\u2019s and health organizations kicked off the Even the Score campaign, which argued that the drug regulatory agency was guilty of \u201cpersistent gender inequality\u201d in terms of treatments for sexual dysfunction. To back up its claim, it noted that the FDA has approved more than 20 drugs to treat sexual dysfunction in men and not a single such drug for women.<\/p>\n

\"Sprout
Sprout fought long and hard to win FDA approval of flibanserin, a drug designed to treat decreased sexual desire in women.<\/figcaption><\/figure>\n

Two-Day FDA Hearing <\/b><\/p>\n

In October the FDA held a two-day hearing on the unmet need for drugs to treat female sexual dysfunction. Both sides in the continuing debate turned out in force and made known their feelings about gender inequality and whether or not flibanserin should get approval.<\/p>\n

In February 2015 Sprout resubmitted its petition for flibanserin approval, including with it details about the results of the additional studies FDA had requested. In early June, an FDA advisory panel voted 18-6 to recommend that the FDA approve flibanserin with conditions. Those conditions would require that prescribers and providers of the drug be certified under the FDA risk evaluation and mitigation strategy (REMS) program and also would require a boxed warning on drug packaging against using the drug concurrently with alcohol or antifungal medications.<\/p>\n

Sprout\u2019s Big Week <\/b><\/p>\n

All of which brings us to Sprout\u2019s big week, which kicked off on August 18, 2015, the last day for FDA action on its advisory panel\u2019s recommendation. As the committee had recommended, the agency approved the drug but only with the conditions the panel had suggested.<\/p>\n

On August 20, 2015, in a move that took many observers of the pharmaceuticals industry by surprise, Canada-based Valeant announced its intention to acquire Sprout for roughly $1 billion. While some media observers tried to portray the Whiteheads\u2019 sale to Valeant as a blatant case of \u201ctake the money and run,\u201d Cindy Whitehead made clear that she\u2019s not going anywhere. She said she plans to continue to lead Sprout, which will become a division of Valeant if the acquisition goes through. She said she was \u201cvery excited to continue working with our 34 employees.\u201d<\/p>\n

In announcing plans for the Sprout takeover, Valeant CEO J. Michael Pearson said, \u201cDelivering a first-ever treatment for a commonly reported form of female sexual dysfunction gives us the perfect opportunity to establish a new portfolio of important medications that uniquely impact women.\u201d<\/p>\n

Photo credit: Day Donaldson<\/a><\/em><\/p>\n

Don Amerman<\/i><\/a> is a freelance author who writes extensively about a wide array of nutrition and health-related topics. <\/i><\/p>\n","protected":false},"excerpt":{"rendered":"

For tiny Sprout Pharmaceuticals, it was quite a week! On Tuesday, August 18, 2015, the U.S. Food and Drug Administration gave the company\u2019s only drug a conditional go-ahead, and barely two days later the North Carolina-based company announced that it was being acquired for a cool $1 billion by Valeant. Valeant\u2019s move to acquire Sprout […]<\/p>\n","protected":false},"author":1,"featured_media":8512,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_autoblog_aioseo_focus_keyphrase":"","_autoblog_aioseo_title":"","_autoblog_aioseo_description":"","footnotes":""},"categories":[20],"tags":[],"class_list":["post-8514","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-erectile-dysfunction"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t