BARRIER ANNOUNCES POSITIVE DATA ON ORAL ANTIHISTAMINE

Barrier Therapeutics announced results of a Phase IIa proof-of-concept study of oral Hivenyl in the treatment of moderate to severe itching related to atopic dermatitis that indicate that Hivenyl significantly reduces itch symptoms without signs of sedation. Hivenyl is an oral formulation of vapitadine dihydrochloride, a novel antihistamine that Barrier is developing as a treatment for allergic reactions of the skin, such as those associated with hives, and for the itch associated with atopic dermatitis.

In this multicenter, double-blind, placebo-controlled study, 44 adult patients with atopic dermatitis underwent a one-week lead-in period followed by randomization to treatment with oral Hivenyl 60 mg twice daily or placebo for one week. All patients were also treated daily with a topical corticosteroid and an emollient throughout the study. Nine of the 23 patients in the Hivenyl group reported either a marked improvement or an almost complete relief of their itch symptoms versus none of the 21 patients in the placebo group. In addition, the overall clinical severity score of the atopic dermatitis lesions was reduced in those same nine Hivenyl-treated patients. The drug was well tolerated and no patients reported signs of sedation, which supports similar findings in prior studies with Hivenyl.

The results of two previous dose-escalation Phase I clinical trials suggest that Hivenyl inhibits allergic reactions, has a fast onset of action and does not cause sedation. In these trials, no cardiovascular side effects or sedation were experienced at doses of five to 15 times those that elicited an antihistamine response, according to the company.