FDA Rejects Avanir’s Herpes Treatment

Avanir Pharmaceuticals, a San Diego-based company that’s trying to get its first product on the market, said the Food and Drug Administration rejected the item, a herpes cream. The FDA said more evidence of the drug’s effectiveness, including at least one additional clinical trial, is needed before it would qualify for approval. The company said it still hopes to demonstrate that the cream works. The FDA decision was unexpected. Avanir executives said just last month they were finalizing plans for launching the cream to treat acute outbreaks of oral-facial herpes, commonly known as cold sores. Bristol-Myers Squibb Co. canceled its license to market the cream, originally known as Lidakol, in North America last December. Avanir changed its name from Lidak Pharmaceuticals in November. Avanir’s shares plunged $1.38 to close at 72 cents on Nasdaq. About 50 million Americans have recurring cold sores each year, causing painful and unsightly blisters around the mouth. The drug was designed to speed healing and reduce symptoms from the outbreaks.