AEGiS-Reuters: Unimed diarrhea drug delayed by FDA request

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Unimed diarrhea drug delayed by FDA request

Reuters NewMedia, Inc.; Wednesday May 6, 3:57 pm EST

GAITHERSBURG, Md., May 6 (Reuters) - Unimed Pharmaceuticals Inc. said Wednesday that a U.S. Food and Drug Administration advisory panel has requested additional information about the company's Cryptaz diarrhea treatment before it decides whether to recommend the drug to the FDA for marketing clearance.

In a statement, the company provided no details of the specific information requested by the FDA's antiviral drugs advisory committee.

The stock, which was halted for trading ahead of the announcement, shot up the ranks of the Nasdaq percentage losers list on Wednesday, dropping by 2-1/2, or more than 30 percent to $5-1/4 after it reopened in late-afternoon trading.

"We will closely examine the issues raised by the committee and take the needed steps to ensure Cryptaz can be cleared for marketing as soon as possible," Ronald Goode, Unimed president and chief executive, said in a statement.

"Clinical trials with Cryptaz have demonstrated improvements for people with life-threatening diarrheal infection, and we will work very hard to make it available to patients as rapidly as possible," he added.

Cryptaz, if approved, would be the first treatment for cryptosporidial diarrhea, a chronic, life-threatening disorder for people with the HIV virus and other immune disorders, where slim progress has occurred on drugs to combat these conditions.

The Chicago-based company presented information from U.S. studies that included 228 people with the HIV virus. In three clinical trials of patients with cryptosporidial diarrhea, 45 percent exhibited a complete clinical response (defined as at least a 50 percent reduction in liquid stool frequency).

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