BioSante’s LibiGel Safety Study Concludes As Additional Efficacy Trials Loom On Horizon
This article was originally published in The Pink Sheet Daily
Executive Summary
Ending the cardiovascular and breast cancer safety study provides significant cost savings and there is sufficient data to show safety prior to approval, CEO Simes says.
You may also be interested in...
CV Trials For Symptomatic Conditions Feasible But Not Always Practical, FDA Panel Says
FDA committee members generally reject the notion that dedicated safety studies are not possible for peripherally active mu opioid receptor antagonists in chronic pain patients, but acknowledge a low background cardiovascular risk and symptomatic nature of opioid-induced constipation make such trials problematic. The advisors’ opinions on the practicality of such trials in low-risk patients with symptomatic conditions could have implications beyond PAMORAs.
BioSante LibiGel Study Design Changes Could Yield Better Results For Sexual Dysfunction
Two more Phase III studies for the hypoactive sexual desire disorder therapy is the firm’s best financial investment, CEO Simes says, because the revised design is expected to eliminate the greater-than-expected placebo response that derailed the previous studies.
Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.