A (n=363) and placebo (n=63).
Effects on Dyspareunia
In the 1st and 2nd clinical trial, the modified intent-to-treat population of women treated with OSPHENA when compared to placebo, demonstrated a statistically significant improvement (least square mean change from Baseline to Week 12) in the moderate to severe most bothersome symptom (MBS) of dyspareunia (1st trial p=0.0012, 2nd trial p<0.0001). See Table 2. A statistically significant increase in the proportion of superficial cells and a corresponding statistically significant decrease in the proportion of parabasal cells on a vaginal smear was also demonstrated (p<0.0001 for both). The mean reduction in vaginal pH between baseline and Week 12 was also statistically significant (p<0.0001).
Table 2: Week 12 Effects on Dyspareunia (the Woman’s Self-Identified Most Bothersome Moderate to Severe Symptom of Vulvar and Vaginal Atrophy at Baseline). Mean Change in Severity at Week 12 with Last Observation Carried Forward (LOCF), Modified Intent-to-Treat Populationa 1st Clinical Trial Results
Most Bothersome Moderate to Severe Symptom at Baseline OSPHENA 60 mg
(N=110) Placebo
(N=113)
Dyspareunia
Baseline Mean (SD)
LS Mean Change from Baseline (SE)
p-value vs. placebo
2.7 (0.44)
-1.39 (0.11)
0.0012
2.7 (0.45)
-0.89 (0.11)
---
2nd Clinical Trial Results
Most Bothersome Moderate to Severe Symptom at Baseline OSPHENA 60 mg
(N=301) Placebo
(N=297)
Dyspareunia
Baseline Mean (SD)
LS Mean Change from Baseline (SE)
p-value vs. placebo
2.7 (0.47)
-1.55 (0.06)
<0.0001
2.7 (0.47)
-1.29 (0.07)
---
The modified intent-to-treat population (mITT) included only women in the ITT population who at baseline met the inclusion criteria of ≤5 percent superficial cells on a vaginal smear, a vaginal pH > 5.0, and who identified moderate or severe dyspareunia as her most bothersome vaginal symptom.
Definitions: LOCF = last observation carried forward; SD = standard deviation; SE = standard error; LS = least square
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of ospemifene and engraved with “60” on one side. They are available as follows:
NDC 59630-580-10 Bottle of 100 tablets
NDC 59630-580-30 Blister pack of 30 tablets containing 2 blister cards of 15 tablets each
16.2 Storage and Handling
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
17. PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
17.1 Hot Flashes or Flushes
OSPHENA may initiate or increase the occurrence of hot flashes in some women.
17.2 Vaginal Bleeding
Inform postmenopausal women of the importance of reporting unusual vaginal bleeding to their healthcare providers as soon as possible [see Warnings and Precautions (5.2)].
Patient Information
OSPHENATM (os fee’ nah)
(ospemifene)
tablets
Read this Patient Information before you start taking OSPHENA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about OSPH
