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news.Barrier Therapeutics has announced positive results of a Phase II study with Hivenyl, the company's novel oral formulation of the antihistamine agent vapitadine dihydrochloride.
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In this study, the drug significantly reduced itch symptoms in patients with chronic idiopathic urticaria (CIU), or hives of unknown cause that last for a period of at least six weeks.
Study results showed Hivenyl, dosed at 60mg once daily for one week, met the primary efficacy endpoint of a decrease from baseline in average itch severity score compared to placebo (p=0.037), as measured by patients’s evaluations. The drug was well tolerated and no patients reported signs of sedation, which supports similar findings in prior studies with Hivenyl.
Additional study results showed that the overall assessment by both the patients and the physicians of Hivenyl’s effectiveness in treating CIU compared to placebo was statistically significant (p=0.020 and 0.012, respectively). A positive trend of improvement of other symptoms of urticaria and a clear trend for improvement in quality of life were also observed, but did not reach statistical significance.