The United States Food and Drug Administration approved Osphena (Ospemifene) for the treatment of moderate to severe forms of dyspareunia associated with menopause-related vaginal or vulvar atrophy. The drug should be taken as a once-a-day tablet, which mimics and, acts similar to estrogenic molecules in vaginal tissues. The pharmacological actions of Osphena increase the thickness of the vaginal wall and reduce intercourse-related painful events. The drug should be taken as a short-term treatment to avoid serious iatrogenic adverse events, and to achieve the therapeutic goal.
The agency approved Osphena with a Boxed Warning for healthcare providers and patients. The warning states that the drug can stimulate endometrium that results in thickness, similar to thickening in fertile women. Thickening of endometrial wall is not a part of normal physiological process of postmenopausal women.
The Warning advised the patients to seek immediate medical help if they experience unusual bleeding or frequent spotting to rule out endometrial carcinoma.
According to Dr. Victoria Kusiak, Deputy Director, Office of Drug Evaluation, FDA’s Center for Drug Evaluation and Research, the drug can be a good treatment option for women with dyspareunia symptoms.
Three phases of clinical trials have been conducted to determine the safety and efficacy of Osphena. Around 1889 postmenopausal women were included in the trials with symptoms of vaginal atrophy or vulvar atrophy. The participants randomly received either placebo or Osphena over a period of 12 weeks. After the study period, the results of first two studies found significant improvement of dyspareunia symptoms in the treatment group. However, no improvement has been found in the placebo group. Third study results supported the long-term safety of Osphena in treatment of dyspareunia and its associated symptoms.
The drug is to be marketed with Boxed Label Warning that states the risks of hemorrhagic strokes, deep vein thrombosis and other similar thrombotic events. However, the incidences of such risks are comparatively lesser than risks associated with estrogen-alone treatments.
The commonly reported adverse events of Osphena were vaginal discharge, excessive sweating, hot flashes/flushes and muscular spasmodic reactions.