Positive Phase 2 study results with THVD-102, a combination drug product for the treatment of primary focal hyperhidrosis, or excessive sweating, were presented on October 1, 2016 at the 25th European Academy of Dermatology and Venereology Congress, in Vienna, Austria. David M. Pariser, MD, a leading expert on hyperhidrosis and a founding board member of the International Hyperhidrosis Society presented the study results in the Late-Breaking Session.
The study evaluated the safety and efficacy as well as dry mouth of THVD-102 (oxybutynin 7.5mg plus pilocarpine 7.5mg) versus placebo and oxybutynin alone in subjects with primary focal hyperhidrosis (PFH). Subjects were randomized into 1 of 6 sequences of 3 study treatments (THVD-102, oxybutynin 7.5mg and placebo) in sequential 21-day double-blind crossover treatment periods, each preceded by a washout period of at least 7 days.
A total of 24 subjects were randomized and 19 completed all three crossovers. At baseline, mean Hyperhidrosis Disease Severity Scale (HDSS) score was 3.2 (scale, 1-4).
Changes from baseline to end of treatment in symptoms associated with PFH were statistically significant for both THVD-102 versus placebo and oxybutynin versus placebo as assessed by multiple measures including the HDSS, the Hyperhidrosis Visual Analog Scale (HHVAS) and the Hyperhidrosis Visual Quantification Scale (HHVQS). Beneficial trends for gravimetric measurements were also observed. There were no statistically significant differences between THVD-102 and oxybutynin in PFH efficacy.
Significantly fewer subjects receiving THVD-102 reported “moderate” or “severe" dry mouth while receiving THVD-102 compared to oxybutynin and significantly more subjects categorized their dry mouth as “none” or “mild” while receiving THVD-102 compared to oxybutynin.
“A well-tolerated, oral treatment for hyperhidrosis would address an important unmet need for patients and physicians,” said Benjamin F. McGraw, III, PharmD, Chairman and CEO of TheraVida, Inc., which is developing THVD-102.
Hyperhidrosis can affect multiple areas including the underarms, the palms of hands, soles of feet, face and other areas. Current treatments, which include injections of botulinum toxin, are expensive, painful and are limited to affecting only localized areas of the body.
“Hyperhidrosis can significantly impair the social, occupational and emotional well-being of patients and current treatments are lacking in many ways. I’m very encouraged by these study results,” said Dr. Pariser.
THVD-102 is a combination drug product composed of a muscarinic antagonist (oxybutynin) and a muscarinic agonist (pilocarpine) in a twice daily, oral formulation for the treatment of primary focal hyperhidrosis. In multiple trials, oxybutynin has shown activity in hyperhidrosis but is rarely used due to poor patient tolerance, most commonly dry mouth. Pilocarpine counters the dry mouth caused by oxybutynin without interfering with the beneficial effect of oxybutynin when the two drugs are formulated together in a manner that is covered by the intellectual property of TheraVida, Inc.
About TheraVida, Inc.
TheraVida is a clinical stage pharmaceutical company dedicated to the development of new therapies to improve the lives of patients with hyperhidrosis. For more information, visit www.theravida.com.
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Last updated on: 03/10/2016
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