What is Osphena?
Osphena (ospemifene) is a non-hormonal medication developed by Shionogi Inc., a Japanese pharmaceutical company. Its development was targeted towards treating certain symptoms of menopause. In February 2013, the U.S. Food and Drug Administration (FDA) approved Osphena for the treatment of moderate to severe dyspareunia (painful sexual intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
What are the uses and side effects of Osphena?
Osphena works by behaving like estrogen in certain parts of the body. While it mimics the behavior of estrogen on the lining of the uterus (endometrium) and the vagina, it does not behave in the same manner in the breasts or the heart, where estrogen stimulation can potentially lead to adverse effects.
Osphena’s targeted action makes it effective in treating the vaginal dryness, itching, and burning often experienced by postmenopausal women, as well as reducing pain during sexual intercourse. In this way, it improves the quality of life for women experiencing these discomforts due to menopause.
However, like any medication, Osphena has potential side effects. The most common side effects include hot flashes, vaginal discharge, and excessive sweating. Less common but more severe side effects include the potential for blood clots and stroke, especially in women who smoke or have a history of these conditions. Some women may also experience changes in their menstrual cycle or unusual bleeding, which should be reported to a healthcare provider as these could be signs of endometrial cancer. This is not an exhaustive list and any new or worsening symptoms should be reported to a healthcare provider.
It’s important to note that Osphena is not approved for use in women who have, have had, or suspect they may have breast cancer or a history of blood clots. Always consult with a healthcare provider for personalized medical advice.
Have there been any lawsuits from people who used Osphena?
Based on the most recent data available, there have not been any lawsuits filed directly related to the usage of Osphena1. However, legal developments concerning Osphena are not limited to those involving product usage alone. Recently, the manufacturers of Osphena, Shionogi and Duchesnay, filed a lawsuit against Hetero Labs. The crux of this lawsuit revolves around patent infringement. Shionogi and Duchesnay allege that Hetero Labs’ proposed generic version of Osphena violates their patent, which covers the formulation of ospemifene, the active ingredient in Osphena. This patent, held by Shionogi’s QuatRx unit, is due to expire in July 2028.
The patent-protected treatment is used to alleviate symptoms of painful sexual intercourse and vaginal dryness caused by menopause. Shionogi and Duchesnay are seeking a court order to block the production of generic copies of Osphena until the patent has expired. The case was filed in federal court in Wilmington, Delaware2.
This recent litigation underscores the complexities of pharmaceutical patent law, particularly when it comes to generic versions of branded drugs. While this lawsuit does not relate directly to the side effects of Osphena, it is an important development for stakeholders to monitor, as it may impact the availability of generic alternatives to Osphena in the future.
More information about Osphena
Please review these sites for more details on Osphena:
- Osphena.com – official website
- WebMD.com – Osphena
- PeoplesPharmacy.com – Osphena