Since the studies were conducted in a select patient population, a Risk Evaluation and Mitigation Strategy (REMS) was needed, he said, with prescriber certification to make sure it is prescribed to appropriate patients, who are those as close as possible to the patients enrolled in the study.
Since 2009, when Boehringer Ingelheim submitted the drug for approval, the FDA has declined twice to approve flibanserin. Reasons for the first decision not to approve included inadequate evidence that it was effective and the need for more information on its effects when used with other drugs and alcohol.
In 2013, it was resubmitted for approval by the new manufacturer, Sprout Pharmaceuticals, with another phase III study and other data, but it was not approved by the FDA for reasons that included numerically small treatment differences compared with placebo that did not outweigh safety concerns, according to the agency. The company appealed this decision, which was denied, and then conducted an additional study and filed for approval again.
During the open public hearing, numerous representatives of health organizations and women with HSDD cited the critical need for an FDA-approved option for women with the disorder, who currently have a multitude of unapproved, unproven, and questionable products marketed for this use.
Speakers opposing approval cited the small magnitude in improvements (at best, 8 more SSEs a year), which were not outweighed by the risks, and other issues, including the inclusion of only two women in the alcohol interaction study, the likelihood of off-label use in postmenopausal women, and the possibility that the drug could result in a significant number of syncope cases.
The FDA usually follows the recommendations of its advisory panels. Panelists were cleared of potential conflicts of interest related to the topic of the meeting. The FDA is expected to make a decision by August 2015.