Positive data from Phase II trial of Tolenix (TheraVida) for treatment of Overactive Bladder

TheraVida has announced positive results from a Phase II clinical trial of Tolenix (tolterodine and pilocarpine) for the treatment of Overactive Bladder (OAB) and urge urinary incontinence (UUI). The aims of this randomized, double-blinded, multiple-crossover trial were to assess the safety and efficacy of Tolenix in reducing the frequency of micturition and incontinence episodes per day, as compared to both placebo control and active control Detrol (tolterodine tartrate).

Patients receiving Tolenix experienced statistically significant improvements in their OAB and UUI symptoms over placebo control, as well as efficacy similar in magnitude to the maximum dose of active control Detrol. Patients receiving Tolenix exhibited no significant safety issues, and demonstrated statistically significant and clinically meaningful improvements in their saliva production and dry mouth side effects, as compared to active control Detrol. It also demonstrated a favorable therapeutic index, which may enable higher dosing of Tolenix in some patients. TheraVida intends to present detailed efficacy and tolerability results at an upcoming scientific meeting.