Home > Online Clinic News > Libigel Approved For Continued Trials

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by Robert MacKay, Thursday, February 25, 2010 | Categories: Female Sexual Dysfunction | Flibanserin

Good news for BioSante, a company conducting trials into a new treatment for female sexual dysfunction called Libigel. A data monitoring committee has recommended that the medication is suitable for continued trials after positive data on safety, taken from a phase III clinical trial, was released.

The review of the results involved the panel examining all the unblended adverse events in the safety study, including serious adverse events and cardiovascular and breast cancer events. So far, there have been no deaths, 6 patients developed cardiovascular problems and 4 breast cancer. The low rate of incidence means that the development programme has the go-ahead to continue.

A spokeswoman for BioSante said that their product was the lead pharmaceutical product in development in the US for FSD in surgically menopausal women and added that that they believed that the treatment, a form of testosterone patch, would be the first product to get approval from the FDA for the treatment of the condition.

They will be facing competition from the makers of Flibanserin, a pill which has had extremely promising results in pre-and-post menopausal women suffering from Hypoactive Sexual Desire Disorder.

The company hope to submit Libigel to the FDA for a new drug application in mid-2011. After the results were announced, shares in the company went up by 5%.





 
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