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FDA Approves Once-Daily Topical Combo Of Steroid, Vitamin D for Psoriasis Tx


 

The Food and Drug Administration in January approved Taclonex, a new topical therapy for psoriasis.

The combined steroid and vitamin D3 analogue ointment adds both choice and convenience to the currently available first-line treatments for the disease, Dr. Alan Menter said in an interview. “It's a nice additional drug that will be well received in the marketplace,” he said.

The product, a combination of betamethasone dipropionate 0.064% and calcipotriene 0.005%, has been available in Europe as Daivobet since 2001 and in Canada as Dovobet since 2002, and will be marketed in the United States by Warner Chilcott and LEO Pharma.

“This drug is a significant advance in topical therapy for the U.S. market, although it is old hat for the European market,” said Dr. Menter, chief of dermatology at Baylor University Medical Center in Dallas. He said that he had no conflict of interest involving this drug or its manufacturer. “It is certainly the most interesting and exciting new topical drug for the United States,” he added, predicting Taclonex will renew interest in topical therapy and most likely improve compliance.

“This agent is approved for once-a-day use, which I think is very important, because most patients will not use a topical agent twice a day on a long-term basis,” he said. The combination of both a steroid and a vitamin D analogue in one ointment also should help compliance, he predicted.

There have been no clinical trials of the product in the United States, said Dr. Menter, but a European-industry-sponsored trial comparing continuous and intermittent therapy with the combined drug vs. calcipotriol monotherapy showed greater improvement in psoriasis area and severity index scores (73%) in the continuous therapy group, compared with 68% in the intermittent group and 64% in the monotherapy group. Overall treatment success rates were 66%, 57%, and 51% for the continuous, intermittent, and monotherapy groups, respectively.

'This drug is a significant advance in topical therapy for the U.S. market.' DR. MENTER

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