Addyi (flibanserin): How an upstart biopharma used social media and policy tools to support its NDA approval - and a $1 billion payday

STUDY OVERVIEW

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.

KEY TOPICS

• Introduction: From Rejections to Market Entry
• Adjusting Clinical Development Plan: Path to Approval
• Political Pivot: Developing Political Pressure for Drug Review
• Social Media: Flexible Tool to Inform, Educate and Advocate
• The Decision: Positive Review from FDA
• Ongoing Controversy: Debate on Efficacy, Risks and Clinical Data
• In-Market: Commercial Blues and Future of Addyi
• Lessons Learned & Winning Strategies
  

• Build Policy on Science: Sprout used medical experts to bring credibility to HSDD and the policy issue regarding unequal treatment of women’s health before the FDA
• Using Twitter: Twitter is a powerful platform for education and policy campaigns. Even The Score Campaign ran for 2 years, pulled 1989 followers and generated 1286 tweets

This study was developed using extensive secondary research of government and company information.

Industries Profiled:
Pharmaceutical


Companies Profiled:
Boehringer Ingelheim; Sprout Pharmaceuticals; Valeant

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