Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may notreflect the rates observed in practice.
The efficacy and safety of VYLEESI was studied in two identical, 24-week, randomized, double-blind, placebocontrolledtrials in 1247 premenopausal women with acquired, generalized HSDD. The age range was 19-56years old with a mean age of 39 years old; 86% were White and 12% were Black. Both trials also included a 52-week open-label, uncontrolled extension phase during which 684 patients received VYLEESI [see ClinicalStudies (14)]. Most patients used VYLEESI two to three times per month and no more than once a week.
Serious adverse reactions were reported in 1.1% of VYLEESI-treated patients and 0.5% of placebo-treatedpatients.
Adverse Reactions Leading to Study Discontinuation
The discontinuation rate due to adverse reactions was 18% among patients treated with VYLEESI and 2%among patients treated with placebo. The most common adverse reactions leading to study drug discontinuationin the VYLEESI group were nausea (8%), headache (2%), vomiting (1%), flushing (1%), injection sitereactions (1%), flu-like symptoms (<1%) and increased blood pressure (<1%).
Common Adverse Reactions
Table 1 provides the incidence of common adverse reactions (those reported in at least 2% of patients in theVYLEESI treatment group and at an incidence that was greater than in the placebo group). The most commonadverse reactions included nausea, flushing, injection site reactions and headache. The majority of events werereported to be mild (31%) to moderate (40%) in intensity and transient.
Table 1: Adverse Reactions Occurring in ≥ 2% of Patients in Randomized, Double-Blind Controlled
Trials with VYLEESI in Premenopausal Women with HSDD
VYLEESI
(n = 627)
%
Placebo
(n= 620)
%
Nausea 40.0 1.3
Flushing 20.3 0.3
Injection site reactionsa 13.2 8.4
Headache 11.3 1.9
Vomiting 4.8 0.2
Cough 3.3 1.3
Fatigue 3.2 0.5
Hot flush 2.7 0.2
Paraesthesia 2.6 0.0
Dizziness 2.2 0.5
Nasal congestion 2.1 0.5
a
Includes injection site pain, unspecified injection site reactions, erythema, hematoma, pruritus, hemorrhage, bruising, paresthesia andhypoesthesia
Nausea
In the pooled phase 3 placebo-controlled trials, nausea was the most common adverse reaction, reported in 40%of VYLEESI-treated patients compared to 1% of placebo-treated patients. The median onset of nausea waswithin one-hour post-dose and lasted about two hours in duration. The incidence of nausea was highest after thefirst VYLEESI dose (reported in 21% of patients) then declined to about 3% after subsequent doses. Thirteenpercent of VYLEESI-treated patients received an anti-emetic medication. Overall, 8% of VYLEESI-treatedpatients and no placebo-treated patients prematurely discontinued the trials due to nausea. [see Warnings andPrecautions (5.3)]
Headache
In the pooled phase 3 placebo-controlled trials, headache occurred at a higher incidence in VYLEESI-treatedpatients (11%) than placebo-treated patients (2%). One patient experienced a headache event that was serious(intractable pain leading to hospitalization) and 1% of patients who received VYLEESI discontinued the study
due to headache.
Flushing
In the pooled phase 3 placebo-controlled trials, flushing occurred more frequently |
