BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) For LibiGel(R) In FSD
The SPA process and agreement affirms that the FDA agrees that the LibiGel Phase III clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve a new drug application (NDA) for LibiGel.
"In addition to being a major milestone for BioSante, the SPA is a significant development for the entire FSD category," said Stephen M. Simes, BioSante's president & CEO. "This action by the FDA confirms FDA's position that FSD and HSDD are true diagnosable conditions that women experience, with measurable endpoints that can be evaluated and which deserve therapeutic options."
"With this SPA and meeting minutes received from FDA, we now have a clearly defined, reasonable, feasible and affordable LibiGel development path that can lead to the approval of LibiGel. Since no pharmaceutical product is approved for the treatment of FSD or HSDD in the U.S., LibiGel, if approved by the FDA, will address a truly unserved market. BioSante is committed to the development of LibiGel which ultimately could be the first product approved by the FDA for this treatment in the U.S."
The SPA agreement covers the pivotal Phase III safety and efficacy trials of LibiGel in the treatment of FSD, one of which already has been initiated. The Phase III safety and efficacy trials are double-blind, placebo-controlled trials each of which will enroll approximately 500 surgically menopausal women for six-months of treatment. The primary endpoints in the LibiGel clinical trials are an increase in the number of satisfying sexual events and sexual desire and a secondary endpoint of a decrease in sexual distress. These SPA trials use BioSante's validated instruments to measure the clinical endpoints. BioSante intends to initiate the second LibiGel Phase III safety and efficacy trial in early 2008.
In addition to the two LibiGel Phase III safety and efficacy trials, BioSante recently has initiated a Phase III cardiovascular safety study of LibiGel. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. At the end of the 12 months, BioSante intends to submit a LibiGel NDA for review and possible approval by FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least one of a number of cardiovascular risk factors such as hypertension and diabetes. BioSante announced initiation of this Phase III safety study on January 7, 2008. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also is being tracked throughout the study.
As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p
BioSante Pharmaceuticals anunþã FDA speciale de protocol de evaluare (spa) pentru LibiGel (R) în FSD - BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) For LibiGel(R) In FSD - articole medicale engleza - startsanatate