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US FDA approves Shionogi's osphena tablets to treat moderate to severe dyspareunia

Florham Park, New Jersey
Thursday, February 28, 2013, 17:00 Hrs  [IST]

Shionogi Inc., the US-based company of Shionogi & Co., Ltd., has received the US Food and Drug Administration (FDA) approval for Osphena (ospemifene) tablets for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.

Osphena, as an estrogen agonist/ antagonist with tissue selective effects, is the first and only oral treatment alternative to vaginal or oral steroidal estrogens for women with dyspareunia due to menopause.

Its biological actions are mediated through binding to estrogen receptors, which results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism). The efficacy and safety of Osphena was demonstrated in three clinical trials.

Osphena demonstrated significant improvements in dyspareunia (painful intercourse) as well as on the physical changes of the vagina associated with menopause. These improvements include increased superficial cells and decreased parabasal cells and vaginal pH.

“While more than half of all women in the US will experience symptoms of VVA at some time in their postmenopausal life, the vast majority of women with VVA are not being treated with a prescription medication because women and their healthcare professionals are not proactively discussing the condition, and its associated symptoms,” said David J Portman, MD, OB/ GYN and Director of the Columbus Center for Women’s Health Research.

Portman added, “Osphena received approval based on a clinical development programme in postmenopausal women with dyspareunia, a symptom of VVA. As an oral medication taken once-daily, Osphena is a convenient way for postmenopausal women to help treat dyspareunia.”

“The FDA approval of Osphena represents an important advancement in the treatment of dyspareunia, providing an alternative treatment option for the millions of women living with this condition,” said John Keller, PhD., president and chief executive officer, Shionogi Inc. “We look forward to building our product portfolio in women’s health by advancing important therapies, such as Osphena.”

Shionogi obtained exclusive global marketing rights to Osphena under a license agreement entered into between Shionogi and QuatRx Pharmaceuticals Company in 2010.

Osphena is an estrogen agonist/antagonist with tissue selective effects. Serious risks of estrogen-alone therapy can include increased risk of endometrial cancer, stroke, and deep vein thrombosis (DVT).

Osphena should be prescribed for the shortest duration consistent with treatment goals for the individual woman. Women considering treatment for dyspareunia are encouraged to discuss the potential risks and benefits of Osphena with their healthcare provider.

Dyspareunia (painful intercourse) is one of the most common symptoms of vulvar and vaginal atrophy (VVA), a chronic and progressive condition due to menopause. Declining estrogen levels during menopause can cause tissues of the vaginal lining to grow thinner and to lose elasticity, a condition known as vaginal atrophy. Menopause also causes increases in vaginal pH. These changes can lead to dyspareunia.

Shionogi Inc. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s research and development currently targets three therapeutic areas: infectious diseases, pain, and metabolic syndrome.


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