Study: oral vapitadine cuts itch without sedation.

SAN ANTONIO -- An oral formulation of the investigational drug vapitadine was found to be more effective than placebo in providing itch relief to patients with atopic dermatitis in a recent phase II study.

The drug, an [H.sub.1] antihistamine, also did not produce any sedative effects--a common criticism of other such itch-relief medications--according to the results of a randomized controlled trial presented at the annual meeting of the American Academy of Dermatology.

Braham Shroot, Ph.D., chief scientific officer of Barrier Therapeutics Inc., reported the results in a poster session on behalf of Dr. J.M. Naeyaert of the department of dermatology at the University of Ghent (Belgium) and fellow investigators. Barrier, sponsor of the study, manufactures vapitadine dihydrochloride under the trade name Hivenyl.

After a 1-week, run-in phase, 43 patients were randomly assigned in a double-blind fashion to receive vapitadine (22 patients) or placebo (21 patients). Vapitadine (60 mg) and placebo were administered by the patients twice daily for 7 consecutive days. The patients also applied 1% hydrocortisone acetate cream and an emollient throughout the run-in and treatment phase.

Each day, patients recorded their itching twice in a diary using a visual analog scale. They also recorded their sleep quality.

Itching among the placebo group was reduced by a mean of 4.9 points from baseline, while that of the treatment group was reduced by 14.8 points--decreases that reached statistical significance.

There was no reported somnolence or sedation, but nighttime sleep quality improved slightly in both groups. There also was no effect on severity or extent of the atopic lesions, possibly because of the short treatment period, noted Dr. Shroot. No serious adverse events were reported.

BY JOHN R. BELL

Associate Editor