Ther-Rx, Perrigo Launch Gynazole-1 Single-dose Yeast Infection Treatment

The pharmaceutical packaging and product is indicated for local treatment of yeast infections in non-pregnant women.

Ther-Rx Corp., a women's health-focused pharmaceutical company and subsidiary of K-V Pharmaceutical Company (OTCQB Marketplace:  KVPHA/KVPHB), and Perrigo Company (Nasdaq: PRGO; TASE) announced today that Gynazole-1® (Butoconazole Nitrate Vaginal Cream USP, 2%), indicated for the local treatment of yeast infections (vulvovaginal candidiasis infections caused by Candida) in non-pregnant women1, is now available for prescribing.  Gynazole-1 is available at major national and regional retail pharmacy chains across the country.

Ther-Rx has partnered with Perrigo (www.perrigo.com) to manufacture Gynazole-1.  Perrigo is a leading manufacturer of prescription drugs in the U.S. market that has been inspected and approved by the U.S. Food and Drug Administration (FDA) as being in compliance with current Good Manufacturing Practice requirements to manufacture Gynazole-1. 

"We are pleased to be able to once again offer Gynazole-1 to prescribing healthcare providers and to patients in need of therapy," said Greg Divis, President of Ther-Rx and CEO of K-V Pharmaceutical Company.  "The availability of Gynazole-1 represents a positive step forward for the Company as we continue to provide quality, patient-friendly products to support the health of women across the stages of their lives."

Yeast infections (VVC) are very common in women.  The 2010 Centers for Disease Control and Prevention (CDC) guidelines state that an estimated 75% of women will have at least one episode of VVC, and 40%–45% will have two or more episodes of VVC, within their lifetimes.2  Gynazole-1, the only one-dose, anytime prescription cream for the treatment of vaginal yeast infections caused by all Candida species in non-pregnant women, is on the CDC recommended list.

"Women experiencing vaginal infections are eager for treatments that provide fast initial relief from symptoms and convenience in dosing and administration," said David Gandell, MD, Clinical Professor of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry.  "Gynazole-1 is a well-established treatment option, so it's great to be able to prescribe it for my patients again."

Gynazole-1 (Butoconazole Nitrate Vaginal Cream USP, 2%) is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida). The diagnosis should be confirmed by KOH smears and/or cultures.

Note: Gynazole-1 is safe and effective in nonpregnant women; however, the safety and effectiveness of this product in pregnant women has not been established.

Important Safety Information for Gynazole-1 (Butoconazole Nitrate Vaginal Cream USP, 2%)

5.7% of patients enrolled in the Gynazole·1 clinical trials reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. 1% of patients had treatment-related complaints. 2% of patients discontinued the study due to adverse events.

This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with Gynazole·1 is not recommended.

Recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (HIV) in women who are considered at risk for HIV infection.

If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.

Full prescribing information can be viewed at www.gynazole-1.com/PI.PDF.   

About Ther-Rx Corporation

Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company, is a specialty branded pharmaceutical company with a primary focus in the area of women's healthcare. As such, we are committed to advancing the health of women across all the stages of their lives.

About Perrigo

From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, dietary supplements and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia. 

Source: Ther-RX Corp. .via NewsEdge

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