BioCentury
ARTICLE | Clinical News

Egalet speeds NDA timeline for abuse-deterrent morphine

March 12, 2015 1:42 AM UTC

Egalet Corp. (NASDAQ:EGLT) rose $1.02 to $14.99 on news that it plans to submit an NDA by YE15 for Egalet-001 for pain management. The company had planned to submit an NDA in mid-2016 for the abuse-deterrent, extended-release oral formulation of morphine.

Egalet also reported that 15 mg and 30 mg Egalet-001 demonstrated bioequivalence to MS Contin morphine sulfate controlled-release oral tablets from Purdue Pharma L.P. (Stamford, Conn.). Egalet-001 employs the company's Guardian technology, which includes an injection molding process to render the product difficult to chew or manipulate. ...