U.S. health regulators approved Pfizer Inc's menopause drug
Duavee, which the company hopes will reduce hot flashes with fewer side
effects than older hormone-replacement therapies.
The Food and Drug Administration said on Thursday it approved the drug to treat women with moderate to severe menopause symptoms and to prevent post-menopausal osteoporosis, a bone disease which can increase the risk of fractures.menopause
The drug, which Pfizer is developing with Ligand Pharmaceuticals Inc, combines bazedoxifene - which belongs to a class of drugs known as selective estrogen receptor modulators, or SERMS - and conjugated estrogens, which are derived from the urine of pregnant horses and contained in Pfizer's menopause drug Premarin.
Understanding
Dyspareunia (dis-puh-roo-nee-uh)
Menopause. It comes with a few
The Food and Drug Administration said on Thursday it approved the drug to treat women with moderate to severe menopause symptoms and to prevent post-menopausal osteoporosis, a bone disease which can increase the risk of fractures.menopause
The drug, which Pfizer is developing with Ligand Pharmaceuticals Inc, combines bazedoxifene - which belongs to a class of drugs known as selective estrogen receptor modulators, or SERMS - and conjugated estrogens, which are derived from the urine of pregnant horses and contained in Pfizer's menopause drug Premarin.
Understanding
Painful Intercourse
Due to Menopause
Dyspareunia (dis-puh-roo-nee-uh)
is the medical term for painful
intercourse.
Moderate to severe painful intercourse is one of the most bothersome symptoms of VVA (vulvar and vaginal atrophy), a real medical condition that women don't associate with menopause. In fact, many women experiencing dyspareunia due to menopause aren't treating it.
Menopause. It comes with a few
surprises.
A woman’s body changes due to menopause. While you may be aware of some of the changes, moderate to severe painful intercourse due to menopause is not a symptom that you may have expected.
The truth is, a decrease in estrogen due to menopause can cause unexpected vaginal changes. When estrogen levels fall, vaginal tissue changes. As a result, intercourse can become painful.
Osphena is the first and only FDA-approved, NON-ESTROGEN, ONCE-A-DAY, ORAL treatment for moderate to severe painful intercourse due to menopause.
Important Safety Information
Most Important Information you should know about Osphena
Osphena (ospemifene) works like estrogen in the lining of the uterus, but can work differently in other parts of the body.
Taking estrogen alone or Osphena may increase your chance for getting cancer of the lining of the uterus, strokes, and blood clots. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell them right away if this happens while you are using Osphena.
You and your healthcare provider should talk regularly about whether you still need treatment with Osphena.
Call your healthcare provider right away if you get changes in vision or speech, sudden new severe headaches, and severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.
Osphena should not be used if you have unusual vaginal bleeding; have or had certain types of cancers, such as cancer of the lining of the uterus; have or had blood clots; had a stroke or heart attack; or think you may be pregnant. Tell your healthcare provider if you have severe liver problems; or are going to have surgery or will be on bed rest.
Possible side effects
Serious but less common side effects can include stroke, blood clots, and cancer of the lining of the uterus.
Common side effects can include hot flashes, vaginal discharge, muscle spasms and increased sweating.
Tell your healthcare provider about all of the medicines you take as some medicines may affect how Osphena works. Osphena may also affect how other medicines work.
Please read the Patient Information for OsphenaTM (ospemifene) tablets, including Boxed WARNING in the Full Prescribing Information.