More Than Three-Quarters of U.S. Women Will Benefit From Butoconazole Nitrate

More Than Three-Quarters of U.S. Women Will Benefit From Butoconazole Nitrate

butoconazole nitrateButoconazole Nitrate, CAS number 64872-77-1 is also known as the brand name GYNAZOLE-1. Marketed by Ther-Rx Corporation, the patent for this vaginal cream expires November 17, 2017. Indicated for the treatment of vulvovaginal candidiasis, or infections caused by Candida, butoconazole is available in a 2% strength cream. Statistically Candida, or yeast infections, are extremely common. In fact, 75 percent of all women are likely to have at least one yeast infection, and up to 45 percent of women will have two or more yeast infections in their lifetime. After bacterial vaginosis, a vaginal yeast infection is the second most common cause of cases of abnormal vaginal discharge in women in the United States. The typical recommended dose of Gynazole (butoconazole) is one applicator of cream, which is approximately 5 grams of the cream administered intravaginally. Lack of treatment for this easily treatable infection can lead to a more serious pelvic infection. There are few side effects including minor itching and burning, increased urination and soreness around the affected area. The benefit of butoconazole cream is that is it extremely efficacious, and cures between 80 and 90 percent of vaginal yeast infections within two weeks or less. Many patients notice a significant improvement in their symptoms within the first few days.

One study, conducted by the Department of Obstetrics and Gynecology at Baylor College of Medicine in Houston, Texas concluded that butoconazole was an effective and safe alternative to longer-term therapy with miconazole nitrate for the treatment of vulvovaginal candidiasis. A single vaginal dose of a butoconazole nitrate, 2% sustained-release cream, was compared with a seven-day schedule of miconazole nitrate vaginal cream 2% in this controlled, multicenter and randomized clinical trial. Involving 205 female patients, the results indicated that a single-dose of butoconazole led to a faster reduction in symptom severity when compared to the initial dose of miconazole 7, and this difference was statistically significant. Generic alternatives of this potent and easy to administer treatment for such a common female condition need to be developed.

LGM Pharma provides the Butoconazole Nitrate API for research and development purposes, and offers clients continued support throughout the entire process.


Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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