TheraVida, Inc., a clinical stage biopharmaceutical company developing novel combination drug products, today presented positive results from a Phase 1 clinical trial of its lead product candidate THVD-201 for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI). In this Phase 1 study, 17 healthy subjects receiving THVD-201 exhibited no significant safety issues related to the product. Meanwhile, subjects in this study did demonstrate major improvements in their salivary output and related dry mouth side effects when receiving THVD-201, as compared to standard anti-muscarinic (tolterodine) therapy for overactive bladder. This data was presented at the 2011 Annual Congress of the European Association of Urology (EAU) in Vienna, Austria.
"TheraVida is pleased to have presented its Phase I results at EAU, since they demonstrate the potential of our combination drug technology and products such as THVD-201, to improve the safety and side effects commonly associated with anti-muscarinic therapy for OAB and UUI," said Mehdi Paborji, Ph.D., Chief Operating Officer at TheraVida.
The Phase 1 clinical trial by TheraVida examined the safety of its THVD-201 combination drug product that contains a proprietary formulation of tolterodine with a salivary stimulant. Two dosages of THVD-201 were studied, the first incorporated standard doses of 2mg immediate release tolterodine, and the second incorporated higher doses of 4mg immediate release tolterodine. Both dosages exhibited satisfactory safety profiles in human subjects. As a result, TheraVida intends to advance the development of THVD-201 into Phase 2 clinical trials. The objective of THVD-201 is to reduce or eliminate the side effects (such as dry mouth) characteristic of tolterodine, and to ultimately improve patient safety, product efficacy, and long-term compliance in the treatment of OAB and UUI.
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