Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced the company has submitted a new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The submission is based on the pivotal pharmacokinetic studies that demonstrated bioequivalence of ARYMO ER 15 mg, 30 mg and 60 mg to equivalent doses of MS Contin (morphine sulfate controlled-release). In addition, the submission includes a comprehensive battery of abuse-deterrent studies (Category 1, 2 and 3) which were conducted to support abuse-deterrent label claims for intravenous injection, snorting and oral abuse.
"Given the need for treatment options for the millions of individuals living with chronic pain, combined with the importance of providing formulations that deter opioid abuse because of the prescription abuse epidemic here in the United States, the NDA submission of ARYMO ER represents an important milestone and is the first NDA from our proprietary Guardian Technology program," said Bob Radie, president and chief executive officer of Egalet. "We look forward to working with the FDA to bring to market ARYMO ER for people living with chronic pain."
Morphine sulfate is an opioid agonist and a Schedule II controlled substance with an acknowledged abuse liability. The risk of accidental misuse and abuse of morphine was the focus of the development program for ARYMO ER, which demonstrated physical and chemical features that are resistant to both common and more rigorous methods of manipulation, based on Egalet's proprietary Guardian Technology.
Egalet's Guardian Technology was developed to deliver commonly abused prescription medications in an abuse-deterrent form. Egalet's proprietary Guardian Technology is a polymer matrix tablet technology that utilizes a novel manufacturing process, plastic injection molding, which results in tablets with controlled-release properties as well as physical and chemical features that have been demonstrated to resist both common and rigorous methods of manipulation. Guardian Technology results in tablets that are extremely hard, very difficult to chew, resistant to particle size reduction, and inhibit/block attempts at chemical extraction of the active pharmaceutical ingredient. In addition, the technology results in a viscous hydrogel on contact with liquid, making syringeability very difficult. These features are important to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation.