Urinary incontinence agent’s new drug application accepted by FDA
Following the launch of the phase II clinical study of its leading compound Litoxetine IXA-001 in Europe and Canada, Ixaltis has announced the FDA’s acceptance FDA of the company’s investigational new drug application. The open application will allow Ixaltis to conduct a clinical study in the U.S. with the objective of assessing the safety, tolerability, and efficacy of Litoxetine as treatment for men and women suffering from mixed urinary incontinence, according to the company.
PCa treatment improves metastasis-free survival in phase III trial
The phase III PROSPER trial evaluating enzalutamide (XTANDI) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic castration-resistant prostate cancer (CRPC) met its primary endpoint of improved metastasis-free survival, Pfizer Inc. and Astellas Pharma Inc. recently announced. The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of enzalutamide in previous clinical trials. Based on the results of PROSPER, the companies intend to discuss the data with global health authorities to potentially support expanding the label for enzalutamide to cover all patients with CRPC.
Patents available for external urine collection catheter
ASG Services Inc. announced the availability of two U.S. and international patents for the manufacture and global sale and distribution of Ur24, an external urine collection catheter. The system’s Human Apparatus attaches to the urethra and is made of a medical-grade, pliable silicone gel and when attached to the urethra, urine can be directed to flow into a collection container that is part of the Urine Collection Apparatus. A combination of one-way valves known as the “breather” allows air into the Human Apparatus, and a low-pressure vacuum then directs the urine to flow into the awaiting Urine Collection Apparatus container, according to AGS Services. Ur24 will be a Class II FDA product that will not require clinical trials, the company said.
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