Society and culture Flibanserin

1 society , culture

1.1 names
1.2 approval process , advocacy
1.3 physician , pharmacy certification
1.4 advocacy groups
1.5 acquisition valeant pharmaceuticals

society , culture

flibanserin developed antidepressant, before being repurposed treatment of hsdd.

names

former proposed abandoned trade names of flibanserin include ectris , girosa, , former developmental code name bimt-17. current brand name addyi

approval process , advocacy

on june 18, 2010, federal advisory panel u.s. food , drug administration (fda) unanimously voted against recommending approval of flibanserin, citing inadequate risk-benefit ratio. committee acknowledged validity of hypoactive sexual desire diagnosis, expressed concern drug s side effects , insufficient evidence efficacy, drug s failure show statistically significant effect on co-primary endpoint of sexual desire. earlier in week, fda staff report recommended non-approval of drug. ahead of votes, boehringer ingelheim had mounted publicity campaign promote controversial disorder of hypoactive sexual desire . in 2010 fda issued complete response letter, stating new drug application not approved in current form. letter cited several concerns, including failure demonstrate statistical effect on co-primary endpoint of sexual desire , overly restrictive entry criteria 2 phase 3 trials. agency recommended performing new phase 3 trial less restrictive entry criteria. on october 8, 2010, boehringer announced discontinue development of flibanserin in light of fda s decision.

sprout responded fda s cited deficiencies , refiled nda in 2013. submission included data new phase 3 trial , several phase 1 drug-drug interaction studies. fda again refused application, citing uncertain risk/benefit ratio. in december 2013, formal dispute resolution filed, contained requirements of fda further studies. these include 2 studies in healthy subjects determine if flibanserin impairs ability drive, , determine if interferes other biochemical pathways. agency agreed call new advisory committee meeting consider whether risk-benefit ratio of flibanserin favorable after additional data obtained. sprout expected resubmit new drug application (nda) in 3rd quarter of 2014.

on june 4, 2015, fda advisory committee, includes bone, reproductive, , urologic drugs advisory committee (brudac) , drug safety , risk management advisory committee (dsrm), recommended approval of drug 18–6, proviso measures taken inform women of drug s side effects. on august 18, 2015 fda approved addyi (flibanserin) treatment of premenopausal women low sexual desire causes personal distress or relationship difficulties. approval specified flibanserin should not used treat low sexual desire caused co-existing psychiatric or medical problems; low sexual desire caused problems in relationship; or low sexual desire due medication side effects.

physician , pharmacy certification

in united states physicians , pharmacies dealing flibanserin have undergo certification process, while patients need submit written agreement abstain alcohol.

advocacy groups

even score, coalition of women s group s brought sprout consultant, actively campaigned approval of flibanserin. campaign emphasized several approved treatments male sexual dysfunction exist, while no such treatment women available. group obtained letters of support president of national organization women, editor of journal of sexual medicine, , several members of congress.

other organizations supporting approval of flibanserin included national council of women s organizations, black women’s health imperative, association of reproductive health professionals, national consumers league, , american sexual health association.

the approval opposed national women s health network, national center health research , our bodies ourselves. representative of pharmedout said approve drug set worst kind of precedent — companies spend enough money can force fda approve useless or dangerous drugs. editorial in jama noted although flibanserin not first product supported consumer advocacy group in turn supported pharmaceutical manufacturers, claims of gender bias regarding fda’s regulation have been particularly noteworthy, have extent of advocacy efforts ranging social media campaigns letters members of congress .

the score campaign managed blue engine message & media, public relations firm, , received funding sprout.

acquisition valeant pharmaceuticals

on 20 august 2015 valeant pharmaceuticals , sprout pharmaceuticals announced valeant acquire sprout, on debt-free basis, approximately $1 billion in cash, plus share of future profits based upon achievement of milestones.