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

Industries Profiled:
Pharmaceutical


Companies Profiled:
Boehringer Ingelheim; Sprout Pharmaceuticals; Valeant

Study Snapshot

Best Practices, LLC conducted extensive secondary research of government and company information to review how Sprout Pharma used social media, active lobbying and policy levers to win approval for its controversial therapy, Addyi® (flibanserin) in female hypoactive sexual desire disorder (HSDD) category.

Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

• 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 Social: Sprout used social media as a policy-shaping and influencing tool during the FDA evaluation phase of flibanserin's third submission.

• Addyi’s birth story
• Market landscape
• Flibanserin’s NDA approval timeline
• Detailed timeline of Addyi’s long journey to approval
• How Sprout Pharmaceuticals set out to succeed where others failed
• Sprout’s brand team spotlight
• Addyi’s focus on educating the world around HSDD

• Addyi’s method of action
• FDA prioritization of HSDD disease area
• FDA rejection of flibanserin for HSDD during the first submission for approval
• Adverse events leading to flibanserin's FDA rejection during the second regulatory submission
• Refining clinical plan to achieve FDA approval reflecting regulatory and clinical measurement hurdles
• Comparative effectiveness of flibanserin against placebo
• Adverse events comparison of flibanserin against placebo

• Using lobbying tools to confront gender bias in women’s health NDAs
• Getting constituents to raise their voices
• Wining support for fair treatment of women’s health NDAs before the FDA
• Garnering political support seeking “thoughtful consideration” of flibanserin’s NDA
• Using Twitter platform for education and policy campaigns
• Building policy on science
• Demanding equity before FDA with “Even The Score” - an innovative political and health advocacy group
• Linking tools to grab more attention

• Use of social media as a policy-shaping and influencing tool during the FDA evaluation phase of flibanserin's third submission
• Use of social media to educate and inform around women’s health issues
• Spotlighting unmet needs through social campaigns
• Using social media to deploy disease state education
• Spotlighting gender bias in treating women’s sexual dysfunction as seriously as male erectile dysfunction
• Supporting bias charge with science and policy analysis
• Campaign highlighting the importance of gender-based analysis
• Giving voice to advocacy groups
• Forging alliances to quickly expand the pool of support
• Demonstrating evidence
• Providing testimonials on social media platforms
• Using Twitter campaign to bring the women’s health issue into public light and discussion
• Spotlighting the impact of HSDD
• Questioning status quo

• FDA approval of Addyi in 2015 amid positive data - but with a few conditions
• Terms of the definitive $1 billion agreement between Valeant and Sprout
• Development of a comprehensive risk evaluation and mitigation strategy (REMS) program

• Reasons to be sceptical of Addyi
• HCP and patient commentaries

• Addyi’s market-entry
• Addyi revenues following launch
• Valeant’s own struggles
• Valeant giving Addyi back to its founders shortly after the drug’s launch

• Lessons learned and winning strategies from Addyi