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Developed in early 2000s for anxiety, flibanserin was repositioned for hyposexual desire disorder in mid-2000s by Boehringer Ingelheim. After initial submission was rejected by FDA in 2010, Sprout Pharma acquired development rights from BI. FDA rejected second clinical submission in 2013 and Sprout used active lobbying, policy and social media campaigns to ensure its NDA was given “full consideration.”
Sprout resubmitted and won FDA approval in 2015 and Addyi (flibanserin) became the first drug approval in HSDD category. Valeant Pharmaceuticals acquired Addyi® for $1 billion one week after FDA approval, but the drug got caught up in problems at Valeant. Sprout buys Addyi® back from Valeant in 2016 and the product is still on the market.
This case study examines how Sprout utilized social media and policy tools to pressure regulators to reconsider previous objections to the drug and to ultimately win approval for Addyi.
This study was developed using extensive secondary research of government and company information.
Boehringer Ingelheim; Sprout Pharmaceuticals; Valeant
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