-DAO Q13 score. The threshold was defined for these studiesby anchoring change from baseline to end of treatment with multiple anchor measures.
There was no significant difference between treatment groups in the change from baseline to end of study visitin the number of satisfying sexual events (SSEs), a secondary endpoint.
Efficacy results for the number of SSEs are summarized in Table 4.Table 4: Efficacy Results for the Number of Satisfying Sexual Events in Premenopausal HSDD Patients
in Study 1 and Study 2 (MITT* Population)
Study 1 Study 2
VYLEESI
1.75 mg
(N = 314)
Placebo
(N = 316)
VYLEESI
1.75 mg
(N=282)
Placebo
(N= 290)
Mean Baseline (SD) 0.7 (1.0) 0.8 (1.1) 0.8 (1.1) 0.7 (1.0)
Mean Change from Baseline
(SD)
0.0 (1.4) -0.1 (1.4) 0.0 (1.3) 0.0 (1.2)
Median Change from
Baseline
0 0 0 0
p- value1 0.76 0.70
1 p-value from unadjusted Wilcoxon rank-sum test.
*MITT: modified intent to treat defined as all patients who were randomized, used at least one dose of double-blind drug and had atleast 1 double-blind follow-up visit. N = the number of patients in the MITT population.
16 HOW SUPPLIED / STORAGE AND HANDLING
VYLEESI (bremelanotide) is supplied as:1.75 mg bremelanotide in 0.3 mL solution in a single-dose, disposable prefilled autoinjector (NDC 64011-701-01) provided in a carton of 4 autoinjectors (NDC 64011-701-04).
Storage
Store at or below 25°C (77°F). Do not freeze. Protect from light.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Transient Increase in Blood Pressure and Decrease in Heart RateAdvise patients that increases in blood pressure and decreases in heart rate may occur after taking each
VYLEESI dose, and that these changes usually resolve within12 hours post-dose [see Warnings andPrecautions (5.1)].
Advise patients not to take VYLEESI within 24 hours of a prior dose and that more than 8 doses per month isnot recommended. Advise patients that taking VYLEESI more frequently or too close together may lead tomore pronounced increases in blood pressure [see Dosage and Administration (2.1)].
Focal Hyperpigmentation
Advise patients that focal hyperpigmentation, including on the face, gingiva and breasts, may occur whenVYLEESI is used intermittently, particularly in patients with darker skin. The incidence may increase withdaily VYLEESI use. Advise patients that the pigmentary changes may not resolve completely after stoppingVYLEESI, and to contact their healthcare provider if they have any concerns about changes to their skin [seeWarnings and Precautions (5.2)].
Nausea
Advise patients that nausea may occur, most commonly with the first injection of VYLEESI, but could occurintermittently with continued use. Advise patients that nausea most commonly lasts for two hours after taking adose but could last longer in some patients, and that anti-emetic medications may be necessary. Advise patientsto contact their healthcare provider for persistent or severe nausea [see Warnings and Precautions (5.3)].
Females of Reproductive PotentialAdvise patients to use effective contraception while taking VYLEESI and to discontinue VYLEESI ifpregnancy is suspected. Advise pregnant patients that there is a pregnancy registry that monitors pregnancyoutcomes in women exposed to VYLEESI during pregnancy [see Use in Specific Populations (8.1, 8.3)].
Manufactured for:
AMAG Pharmaceuticals |
