SAN MATEO, Calif.--(EON: Enhanced Online News)--Positive Phase 2 study results with THVD-102, an orally administered combination drug product for the treatment of primary focal hyperhidrosis, or excessive sweating, were published in the February 2017 issue of the Journal of Drugs in Dermatology.
“Randomized, Placebo- and Active-Controlled Crossover Study of the Safety and Efficacy of THVD-102, a Fixed-dose Combination of Oxybutynin and Pilocarpine, in Subjects With Primary Focal Hyperhidrosis.”
Summary of the study:
- The study evaluated the safety and efficacy as well as the effect on dry mouth of THVD-102 (a novel, proprietary formulation of 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 before each crossover to end of treatment in symptoms associated with primary focal hyperhidrosis 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 in efficacy between THVD-102 and oxybutynin.
- 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.
Recent studies have shown that about 80% of hyperhidrosis patients have multiple areas affected 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 single areas of the body. An oral, systemic treatment would be expected to treat multiple affected areas.
The title of the article was “Randomized, Placebo- and Active-Controlled Crossover Study of the Safety and Efficacy of THVD-102, a Fixed-dose Combination of Oxybutynin and Pilocarpine, in Subjects With Primary Focal Hyperhidrosis.” David M. Pariser, MD, a leading expert on hyperhidrosis and a founding board member of the International Hyperhidrosis Society was the lead author in the publication. “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.
A link to the article can be found below.
THVD-102 is an orally administered 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. Oxybutynin has shown evidence of potential 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 privately held, 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.