Egalet Submits NDA for Morphine Sulfate ER Tablets

Egalet Corporation recently announced the company has submitted an 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 US, 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 API. 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 (eg, chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation.

According to the Institute of Medicine, there are approximately 100 million Americans – more than those affected by heart disease, cancer, and diabetes combined – who suffer from chronic pain, which is often undertreated. Chronic pain is typically defined as pain that lasts beyond the healing of an injury or that persists beyond 3 months. Common types of chronic pain include lower back pain, arthritis, headache, and face and jaw pain. Severe pain typically stops an individual from participating in activities and causes patients to change their behavior to avoid such activities. According to an article in the New England Journal of Medicine, chronic pain is associated with functional loss and disability, reduced quality of life, high healthcare costs, and premature death. Chronic pain also can result in isolation, depression, sleep disorders, and other issues that have a negative impact not only on patients, but also on family members. It is important that these patients, whose chronic pain often interrupts daily life, gain and maintain access to adequate pain relief. Opioid analgesics play an important role in the management of moderate to severe pain and are the most widely prescribed products for pain, with prescriptions exceeding 200 million in 2013.

Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing, and commercializing innovative treatments for pain and other conditions. The Company has two approved products: OXAYDO (oxycodone HCI, USP) tablets for oral use only CII and SPRIX (ketorolac tromethamine) Nasal Spray. In addition, using Egalet’s proprietary Guardian Technology, the company is developing a pipeline of clinical-stage, opioid-based product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO ER, formerly known as Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are being developed for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. Egalet’s Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple APIs with similar or different release profiles. For more information, visit www.egalet.com.