MOUNTAIN VIEW, CA USA (Press Release) - March 22, 2011 -- /PRNewswire-iReach/ --
TheraVida, Inc., a clinical stage biopharmaceutical company developing novel combination drug products, announced 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.
About Overactive Bladder (OAB)
OAB is a disease of ageing that is characterized by an increase in urinary frequency, urinary incontinence, and nocturia. In addition, there is often an increase in the frequency and intensity of urinary urgency in patients. It is estimated that OAB is prevalent in approximately 16% to 17% of the population world-wide, and therefore, is at least as common of a disorder as diabetes. As the world population continues to age over time, the prevalence of OAB is only expected to increase.
THVD-201 is a novel, patent-protected product that combines tolterodine with a modified-release formulation of a salivary stimulant. This product incorporates unique combination drug technology developed by TheraVida that can be applied to any of the standard anti-muscarinic therapies used to treat OAB, to overcome the problematic dry mouth side effect that is typically associated with this class of therapy. TheraVida combination drug products such as THVD-201 also have the potential for greater efficacy in the treatment of OAB, and better patient compliance, when compared to tolterodine alone.
TheraVida, Inc., is a privately-held biopharmaceutical company that was founded with the objective of improving patient care. There is a widely recognized need by patients, physicians, and regulatory agencies, for new medicines that are able to successfully treat disease with improved side effect and safety profiles. Our company is committed to this objective. Using a unique and patent-protected combination drug technology, TheraVida is able to develop products that have significantly better side effect and safety profiles, when compared with predecessor therapies. This same technology also has the ability to generate products that provide better efficacy to patients, in the treatment of various disorders. For more information, contact:
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