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A physician-initiated, double-blind, randomized, placebo-controlled clinical trial comparing the intravesical instillation of a topical botulinum toxin type A formulation (LP-09) to placebo in 24 subjects diagnosed with overactive bladder (OAB) showed significant reductions in both urinary urgency and urinary frequency. This result, published in European Urology, indicates the potential for reducing the need for cystoscopic needle injections when using botulinum toxin for treating OAB patients that are refractory to anti-muscarinic therapy. The clinical trial was conducted at Tzu Chi University, Hualien, Taiwan.

This elimination of the need for cystoscopic injections, if proven effective in larger clinical studies, could significantly impact the market adoption of botulinum toxin for the treatment of OAB. It is important to note that this study showed no treatment-associated urinary retention or increase in the patients’ post-void residual volume, which is a common adverse effect when using cystoscopic needle injection. “The possibility of urinary retention and urinary tract infection are the primary drawbacks of the currently available botulinum toxins when treating OAB,” according to Michael Chancellor MD, Chief Medical Officer of Lipella Pharmaceuticals. In an accompanying editorial, Professor Martin Michel from Johannes Gutenberg University, Mainz, Germany, who was not part of the study, noted that the possibility that botulinum toxin exerts its beneficial effects, at least in part, at the levels of the urothelium and/or afferent nerves raises the possibility that more direct targeting of these sites may maintain efficacy but have improved tolerability.

Lipella Pharmaceuticals Inc., the developer of LP-09, is a specialty biopharmaceutical company focused on the development of topical liposomal formulations for multiple therapeutic applications, including Interstitial Cystitis, Hemorrhagic Cystitis, and Overactive Bladder. Lipella’s initial pre-clinical development of LP-09 in the United States received funding from the National Institutes of Health Small Business Innovation and Research program. Further company details are available at www.lipella.com.

Caution: LP-09 is not currently approved for commercial use in any indication in the United States.

Citations

Kuo H-C, et al. Pilot Study of Liposome-encapsulated OnabotulinumtoxinA for Patients with Overactive Bladder: A Single-center Study. European Urology (2014), http://dx.doi.org/10.1016/j.eururo.2014.01.036

Michel MC. OnabotulinumtoxinA: How Deep Will It Go? European Urology (2014), http://dx.doi.org/10.1016/j.eururo.2014.02.046