Over a month ago, I had the chance to attend hearings at the FDA on a drug being considered for approval for female sexual health. Even as the weeks pass, the experience remains fresh in my mind and catalyzes lots of conversations (with folks who like to discuss this sort of thing). So what was so great. Picture the best Broadway show or movie you have seen recently - can you you feel the drama, the intrigue, the romance, the sit on the edge of your seat, can't wait to see what's next anticipation. Then add the thrill of the Olympics, which as you know for me is like a religious experience - and you get close to feeling what I felt being part of this conversation around female sexuality
Seriously as a vagipreneur, a person in the business of female sexual health, it doesn't get much better than June 4, 2015 (as well as the subsequent reviews, discussions, conversations, since). I mean I saw one of the best shows I have ever seen and will ever see - with the romance, drama, intrigue and emotions of a Tony Award-winning show, an Oscar winning movie and the most memorable Olympic moments all wrapped up in one. I laughed, I cried - it was a full theater experience!!!!
And I wasn't on Broadway, or in Hollywood or in Rio. I was in a windowless, crowded room for 9 hours at the Food and Drug Administration (FDA) for the Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in exotic Silver Spring, MD. I listened to dozens of presentations, saw countless slides, and observed vigorous debate. The purpose of the meeting was to determine if the Advisory Panel (the one with the very long name listed above) would recommend approval of flibanserin for Hypoactive Sexual Desire Disorder (HSDD). And recommend it they did by a vote of 18 to 6, as long as number of specific conditions were met.
So what made it so exciting - apart from the fact that it resulted in the the first drug ever to be recommended for approval for HSDD - and that the same drug had been rejected on the 2 previous attempts, once when submitted by Boehringer Ingelheim in 2010 and then when submitted by Sprout it in 2013.
I have been talking about this weeks and will continue to do so. So just in case you are intrigued, here are the top 5 amazing things about having a front row seat to female sexual health history being made:
The Sufferers: Many women, some with their adult daughters, some with their partners, had the courage to step up to a microphone in a public setting and share the most intimate details of the sad demise of their sexual desire. They shared details so intimate that many would be uncomfortable sharing them in the privacy of their gynecologists office. These women were brave, they were honest, they were desperate, and they were determined that their stories - no matter how painful and personal - be heard.
The Medical Experts: Many of the leading sexual health experts in the world, people who had been on the front line of treating women for decades, came to share their medical, clinical and personal points of view. Practicing clinicians in varied specialties discussed the needs they saw in their offices every day and the emotional agony they heard in their patients' and voices.
The Regulators: If you have never had the opportunity to see the actual process of what a drug goes through to get approved, put this on your bucket list. Serious, well-intentioned, educated, experienced, scientific people reviewed hundred of pages of data, testimony, detailed statistics - all focused on determining if the benefits of flibanserin were sufficiently meaningful to overcome the risks. Regardless of which side of the fence you are on regarding this drug (or any other), it is fascinating to take a peak behind the curtain to see the thought process of people charged with key aspects of our health and available options.
The Advocates: Women who have been on the front lines of women's rights and female health banded together to demand that women be given options. These advocates combined represented hundreds of years of effort for and concern about critical aspects of women's lives. And they were on a mission to "Even the Score."
The Company: Breaking ground is not for the faint of heart. While Sprout still has quite a road of head of it before flibanserin is on the market and available for women, this effort took guts. Despite the pushback, the extra requirements, the investment, the clinicals, and the angst, Sprout got flibanserin further than any other option for HSDD EVER. This hasn't been simple. This hasn't been linear, easy or inexpensive. Sprout and its leadership deserve get some props for endurance.
Reams of articles have been and will be continue to be written about the meeting on June 4, 2015. Dozens of new stories will be reported, countless interviews conducted, thousands of conversations had in doctors' offices, coffee shops, water coolers, offices, bedrooms - and any other place you can think of.
Some patients and their doctors will determine that flibanserin is a good solution for them. Some patients will find that flibanserin provides the answer to their prayers. Others will have to keep waiting. Importantly though, companies, both established, new and those yet to be created, will now have the renewed motivation to continue developing other options - exciting options - providing women with lots of choices for their intimate lives. I, for one, cannot wait.