Regulatory Decision Summary for ADDYI

The submission contained 1 pivotal and 2 supporting Phase 3 clinical trials. The trials were randomized, double-blind, placebo-controlled trials of 24 weeks duration, examining the efficacy and safety of ADDYI. Together, the 3 trials included a total of 3,548 premenopausal women diagnosed with HSDD of which 1,227 patients received ADDYI (100 mg flibanserin taken once per day before bed), and 1,238 received placebo.

The pivotal trial demonstrated that treatment with ADDYI was effective at improving the number of satisfying sexual events (SSEs) by about 1 event a month. Furthermore, a parameter measuring desire (FSFI-D) increased by 1.0 points in the ADDYI group, compared to 0.7 points in the placebo group. Treatment with ADDYI was also associated with a large placebo effect on all parameters. The efficacy findings of the pivotal trial were generally consistent with the efficacy findings of the supportive studies.

During the review Health Canada engaged in consultations with a range of experts. The outcome of the consultations suggested that ADDYI may provide a novel pharmacological means by which physicians may attempt to address HSDD in their patients and that for some individuals the drug may bring improvements in their conditions. The consultations also highlighted a concern surrounding the diagnosis of the condition, which prompted the development of a Prescribing Checklist and a Pharmacist Checklist. These checklists will be made available through the sponsors website, and their intent will be to guide prescribers, pharmacists and patients through the HSDD diagnosis and also to highlight the risks associated with taking the drug.

Safety findings from flibanserin studies were reviewed. The most frequent adverse reactions attributed to ADDYI were dizziness (11.4%), somnolence (11.2%), nausea (10.4%) and fatigue (9.2%). The majority of these adverse reactions were of mild to moderate intensity, emerged during the first 14 days of treatment and lasted for a few weeks to a few months. Infrequent events included severe hypotension, fainting, tachycardia and agitation, as well as disturbances to sleep, mood, cognition and attention. It was also found that the likelihood of experiencing adverse events increased if the patient had liver or heart problems, was taking other medication, consuming alcohol or deviating from ADDYIs dosing instructions.

ADDYIs Product Monograph contains warnings and labelling for the identified risks associated with ADDYI. It also contains contraindications for women with hepatic impairment, for those who are taking drugs that are moderate to strong CYP3A4 inhibitors, and for those who are pregnant and breastfeeding. Women who use ADDYI and have low blood pressure should not consume alcohol. To minimize the impact of side effects, ADDYI should be taken only once a day, before bed and patients should abstain from driving for at least 6 hrs after taking the drug.

The totality of the evidence suggests that the benefits of using ADDYI outweigh the risks for premenopausal women with HSDD. ADDYIs post-market Risk Minimization Plan includes ongoing post-market surveillance, a drug utilization study, and risk minimization activities for prescribers, pharmacists and patients.

For more information on Health Canadas decision, please view the Summary Basis of Decision.