Zyla Life Sciences (fka ZCOR)

[realfast95]

Bret Jensen, Premium Contributor
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Egalet (NASDAQ:EGLT) is up 13% premarket on light volume in response to its announcement that the FDA will allow it to distribute promotional materials and communications to healthcare professionals regarding the abuse-deterrent properties of ARYMO ER (morphine sulfate) extended-release tablets via the intranasal route. Currently, the product labeling only specifies abuse-deterrence characteristics via intravenous and oral routes.
The materials will be based on the data it submitted to the agency in its original New Drug Application which included an intranasal human abuse liability study.
In a letter the company received on Monday, March 27, the FDA stated it "does not object" to its stated plans for distributing the materials if they are based on the NDA data, directed only to healthcare professionals, include appropriate disclosures and are truthful and non-misleading.
The FDA approved ARYMO ER on January 9. The pain medication utilizes the company's Guardian Technology that uses injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
NEW | 29 Mar 2017, 07:49 AM Report Abuse
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