An FDA advisory committee on Monday recommendedreanalysis of data submitted in support of DuraPharmaceuticals Inc.'s new drug application for its Pentydenasal spray for hay fever, the company said.
The stock of the San Diego company (NASDAQ:DURA) fell $1.25to $9.25.
Pentyde is a synthetic peptide whose mode of action isn't fullyunderstood, said David Sudolsky, vice president of businessdevelopment. The product has had a difficult time at the FDA.The company first submitted an NDA in 1988 and resubmittedit in 1989. In February 1991, the FDA sent Dura a letter sayingPentyde was unapprovable. The FDA then agreed to reconsiderapproval once the Pulmonary-Allergy Drugs advisorycommittee met.
On Monday, committee members rated the drug's efficacyabout 3 or 4 on a scale of 1 to 10, said Sudolsky. Threemembers voted to recommend approval, three voted against,and one abstained, he said.
"The bottom line for the company is we have to sit down withthe FDA and figure out what's going to happen with theproduct," said Sudolsky. "We need to hear what the FDAthinks." No date has been set for a meeting.
Dura's first product, bitolterol solution for treatment andprevention of asthma, received FDA marketing approval inFebruary. The drug is licensed from Sterling Winthrop Inc.Dura plans to begin marketing in midyear.
The company, which is developing products to treat asthma,hay fever, the common cold and related respiratory ailments,went public last month with an offering of 2.5 million shares ofcommon stock at $10 per share.
-- Karen Bernstein BioWorld Staff
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