MOUNTAIN VIEW, Calif., March 18, 2013 /PRNewswire/ -- TheraVida, Inc., a clinical-stage biopharmaceutical company developing novel combination drug products, presented positive results from a Phase 2 clinical trial of its lead product candidate, Tolenix ™ (THVD-201), for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI) at the 28 th Annual Congress of the European Urological Association (EAU) in Milan, Italy.
Tolenix ™ is a twice-daily (BID) proprietary combination of tolterodine, to treat OAB and UUI, and pilocarpine, to reduce the significant dry mouth (xerostomia) caused by muscarinic antagonist medications such as tolterodine.
The objectives of the randomized, double-blinded, multiple-crossover Phase 2 trial were to assess the safety and efficacy of Tolenix ™ in reducing the frequency of micturition (urination) and incontinence episodes per day, as compared to both placebo control and active control Detrol ® (tolterodine). In addition, common side effects of muscarinic antagonist therapies, such as dry mouth, were carefully assessed in the 138 patients enrolled in the trial. This international Phase 2 clinical trial was conducted in South Korea, Australia, and New Zealand.
Patients receiving Tolenix ™ (2mg tolterodine plus 9mg pilocarpine, administered BID) experienced statistically significant improvements in their OAB and UUI symptoms over placebo, with a reduction in daily micturitions of 0.88 (p<0.0001) and a reduction in daily incontinence episodes of 0.47 (p<0.0001). This efficacy was similar in magnitude to the maximum dose of active control Detrol ® (2mg tolterodine, administered BID).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. In a substudy, mean saliva production in patients receiving Tolenix ™ was restored back to a level similar to placebo treatment. Dry mouth symptom severity was assessed using a 100mm visual analog scale (VAS) for all subjects in the study. Tolenix ™ demonstrated a 60% reduction in dry mouth severity that was statistically significant (p<0.0001) when compared to active control Detrol ®, as measured by VAS. In addition, patients noted a statistically significant (p=0.006) improvement in their quality of sleep with Tolenix ™, relative to Detrol ®, when assessed by VAS. These data were presented during the "Nocturia, OAB, metabolic syndrome - towards a new management" session on Sunday, March 17 th, in a poster titled: "Tolenix ™ (THVD-201), a novel combination of muscarinic antagonist (tolterodine) and muscarinic agonist (pilocarpine), is efficacious in OAB with less dry mouth compared to tolterodine alone." "It is well known that dry mouth is a primary reason why patients stop taking medicines to treat their OAB and UUI symptoms. These clinical results demonstrate that Tolenix ™ has the ability to provide patients with effective bladder control while reducing the significant and bothersome dry mouth side effects typically associated with OAB medications, such as Detrol ®," said Roger Flugel, Ph.D., TheraVida's Chief Executive Officer. "The unique combination of muscarinic antagonist and agonist in Tolenix ™ did not result in any loss of efficacy, in terms of bladder control. Meanwhile, a statistically significant improvement in dry mouth was observed with Tolenix ™, as compared to Detrol ®. With these highly promising Phase 2 results, we look forward to conducting additional international clinical trials of Tolenix ™ in patients with OAB and UUI." About Overactive Bladder (OAB)OAB is primarily a disease of aging, characterized by an increase in urinary frequency, urinary incontinence and nocturia (waking at night to urinate). OAB is a common disorder, affecting approximately 16% to 17% of the population worldwide, with prevalence similar to diabetes or asthma. As the world population continues to age, the prevalence of OAB is expected to increase. About Tolenix ™ (THVD-201)Tolenix ™ is a novel, patent-protected therapeutic that combines the muscarinic antagonist tolterodine with a modified-release formulation of the muscarinic agonist (salivary stimulant) pilocarpine. Tolenix ™ incorporates a unique and proprietary combination drug technology developed by TheraVida that can be applied to any of the standard muscarinic antagonist therapies used to treat OAB, to overcome problematic dry mouth typically associated with this class of pharmacological agents. TheraVida combination drug products such as Tolenix ™ have the potential for greater efficacy, improved tolerability, and better patient compliance, when compared to tolterodine alone for the treatment of OAB and UUI. About TheraVidaTheraVida, Inc., is applying its unique and patent-protected combination drug technology to develop products that offer patients therapeutic benefits with significantly better side effect, safety, and efficacy profiles when compared with conventional standard-of-care therapies. The company's lead product Tolenix ™ (THVD-201) is being developed for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI) and is advancing into Phase 3 clinical studies. For further information, please visit www.theravida.com SOURCE TheraVida, Inc.