FDA to evaluate safer opioid tablets made by Wayne firm
Egalet Corporation, Wayne, said Monday the Food and Drug Administration has accepted its new drug application for an extended release version of morphine. The company hopes the drug will be approved as early as mid-October.
Egalet Corporation, Wayne, said Monday the Food and Drug Administration has accepted its new drug application for an extended release version of morphine. The company hopes the drug will be approved as early as mid-October.
Egalet's technology aims to make prescription pain medications less prone to abuse, through a high-pressure molding process of the tablets similar to what is used in plastics.
Traditional opioid pain killers, such as morphine and OxyContin, can be abused by crushing to snort, or dissolving to inject. By making a pill that cannot be easily chewed, crushed, or snorted, Egalet hopes to cut down on one way addicts get a quicker high.
Egalet is not the only company working to develop abuse-deterrent painkillers.
The FDA said it will hold an advisory committee meeting to discuss the company's application. "We look forward to working with the FDA during the review process in order to bring this product to market as quickly as possible," said Egalet chief medical officer Jeffrey Dayno.
Shares of Egalet were trading down 30 cents to $6.71 in early afternoon tradingon the Nasdaq.
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