Shionogi Inc. Initiates Phase 3 Clinical Study Of Osphena® For The Treatment Of Postmenopausal Vaginal Dryness

FLORHAM PARK, N.J.–(BUSINESS WIRE)– Shionogi Inc. announced today the company has initiated a Phase 3 clinical trial to evaluate the safety and efficacy of Osphena® (ospemifene) for the treatment of moderate to severe vaginal dryness, a symptom of vulvovaginal atrophy (VVA), due to menopause.

“Vaginal dryness is one of the most common and uncomfortable symptoms of VVA experienced by postmenopausal women,” said Juan Camilo Arjona Ferreira, MD, Senior Vice President, Clinical Development. “We look forward to the results of this study and the potential to offer the women who suffer from this condition an oral, non-hormonal treatment option.”

Osphena is FDA approved for the treatment of moderate to severe painful sex known as dyspareunia, a symptom of VVA due to menopause.

The randomized, double-blind, placebo-controlled multicenter study will assess the safety and efficacy of Osphena 60 milligrams (mg) once-daily oral therapy in postmenopausal women with vaginal dryness as the most bothersome symptom (MBS) of VVA due to menopause. About 600 postmenopausal women between the ages of 40 and 80 will be randomized in a 1:1 ratio to treatment with Osphena or placebo. Safety and efficacy will be assessed at 12 weeks, and study participants will be followed for two years.

Vaginal dryness is one of the most prominent symptoms of VVA, which is caused by declining estrogen levels during menopause and results in the thinning and inflammation of the vaginal walls. The prevalence of VVA among postmenopausal women is nearly 50 percent.

Important Safety Information for Osphena

Most Important Information you should know about Osphena

Osphena 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. 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.

Osphena may increase your chance of getting strokes and blood clots.

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 have had certain types of cancers (including cancer of the breast or uterus); have or had blood clots; had a stroke or heart attack; have severe liver problems; are allergic to Osphena or any of its ingredients; or think you may be pregnant. Tell your healthcare provider if you are going to have surgery or will be on bed rest.

Possible side effects of Osphena

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 and supplements you take as some medicines may affect how Osphena works. Osphena may also affect how other medicines work.

Please  click here  for Full Prescribing Information, including Boxed WARNING.

About Shionogi Inc.

Shionogi Inc. is the U.S.-based subsidiary of Shionogi & Co., Ltd., a Japanese pharmaceutical company with a 137-year history discovering and developing innovative therapies. Shionogi Inc. continues this focus on the development and commercialization of high quality medicines that protect the health and well-being of the patients we serve. The company currently markets products in several therapeutic areas including women’s health, anti-infectives, pain, and cardiovascular diseases. Our pipeline is focused on infectious disease, pain, CNS, and oncology. For more details, visit www.shionogi.com. For more information on Shionogi & Co., Ltd., visit www.shionogi.co.jp.

Forward Looking Statement

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

© 2015 Shionogi Inc. Florham Park, NJ 07932. All Rights Reserved.

Osphena is a registered trademark of Shionogi and Co., Ltd. Osaka, Japan.