FDA to assess female libido drug
pharmafile | June 4, 2015 | News story | Sales and Marketing | FDA, Sprout Pharmaceutical, flibanserin, libido
The FDA is inching closer to a historic approval of a drug in the US commonly dubbed ‘Viagra for women’.
An advisory committee is due to meet on 4 June to weigh up the pros and cons of flibanserin (which has a proposed trade name of Addyi), a novel treatment for hypoactive sexual desire disorder (HSDD) in pre-menopausal women.
North Carolina-based Sprout Pharmaceuticals acquired Addyi from its original developer Boehringer Ingelheim in 2010. The drug had initially been investigated as an antidepressant, but pre-clinical evidence suggested that its effects in the brain increase dopamine and noradrenalin – while reducing serotonin – and that this can improve sexual desire.
Sprout submitted the drug for FDA consideration in February, after completing additional clinical trials requested by the US drug regulator after an application was assessed in 2010, and again in 2013.
At the time Sprout chief executive Cindy Whitehead said: “The FDA has devoted significant resources to understand HSDD and the need for medical treatment. I believe that the Agency’s efforts to bring together panels of patients and clinical experts will prove to be a significant step in bringing about a solution for women with HSDD to market.
“I am optimistic that women and their partners affected by the life impact of HSDD will have their first potential medical solution.”
The FDA defines HSDD as “absent or reduced sexual desire associated with personal distress”. The briefing document published ahead of the committee meeting sets out the case for and against the drug’s approval, and what the document describes as ‘challenging scientific issues’.
On the controversial question of whether HSDD is a treatable medical condition, the FDA cknowledges that it “has recognised for a long time that there are women who have reduced sexual desire that causes distress, and who would benefit from safe and effective treatment. This condition is clearly an area of unmet medical need.”
The clinical trial data submitted by Sprout suggests that between 43% and 60% of Addyi-treated patients responded on three important endpoints: satisfying sexual events, sexual desire and distress related to low sexual desire. In one trial this translated to an increase of one satisfying sexual event a month more than women taking a placebo.
But the committee is concerned about the drug’s safety profile, after some women in clinical trials experienced side effects related to the drug’s effects on the central nervous system (sleepiness, fatigue) and dizziness, low blood pressure and fainting.
There is a suggestion that some side effects may be worse if women consume alcohol heavily, although Sprout has offered to put a ‘risk management programme’ in place to promote the safe use of Addyi. It insists that “the benefit-risk profile of flibanserin for the treatment of premenopausal women with HSDD is highly positive and warrants approval”.
Sanofi gets FDA Breakthrough
Meanwhile in other news, the FDA has granted Breakthrough Therapy designation to olipudase alfa, a drug developed by Sanofi’s biologics arm Genzyme, as a treatment of non-neurological manifestations of a disease called acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease Type B.
“There is tremendous unmet need in the ASMD/Niemann-Pick Type B community, and we are hopeful that olipudase alfa can be developed into a meaningful treatment for patients,” says Genzyme’s global head of rare diseases, Richard Peters.
“We appreciate the FDA’s support for this important program giving us the opportunity to utilise an important expedited drug development pathway for olipudase alfa and providing hope for patients affected with a chronic and progressively debilitating disease.”
Lilian Anekwe
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