Sprout Pharmaceuticals won FDA advisory panel recommendation of its female sex drive drug, Addyi, dubbed by media "Viagra for women."
Edelman works the PR front for Raleigh, N.C.-based Sprout, which said the June 4, 18-6 panel vote moves it "one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction," hypoactive sexual desire disorder, or HSDD.
Amy Rose, executive VP of health media for Edelman and a Merck alum, reps Sprout.
The drug, flibanserin, originally planned as an antidepressant by Boehringer Ingelheim and sold to Sprout in 2011, was rejected by the FDA twice in the past five years over efficacy and safety issues.
The Wall Street Journal said the panel nod could mark "a turning point in women's health," where a debate over whether sexual dysfunction is actually a medical problem.
In giving its nod, the FDA advisory committee acknowledged "extensive publicity surrounding" the drug and treatments for female sexual dysfunction and hit as "misleading and inaccurate" accusations that the FDA is holding such drugs to more stringent approval because of gender bias at the agency.
An online campaign backed by drug makers and women's health groups called Even the Score has lobbied the FDA to approve more treatments for women's sexual health.
The FDA committee recommended a risk evaluation and mitigation strategy, or REMS, to include a communications plan targeting prescribers, pharmacists, professional organizations and other healthcare providers about decreased sexual desire and the risks associated with the drug, including hypotension and increased risk with alcohol use.
Sprout hopes to gain approval of the drug by mid-August. The FDA does not have to accept the panel's recommendation, but considers the report in its final decision.
Lo Isidro, senior director at Real Chemistry with more than a decade of strategic communications and PA experience, has joined Narrative Strategies.
Nelson Fernandez, former North American chair of APCO Worldwide and managing director of Burson-Marsteller, has joined Volunteers in Medicine Berkshires as director of communications and PA.
Lilit Bargar, who was most recently an EVP in the healthcare practice at Weber Shandwick, comes on board at GCI Health as EVP, corporate practice lead.
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