FDA approves Arymo ER (morphine sulfate)
Egalet Corporation recently announced that the U.S. Food and Drug Administration (FDA) has approved Arymo ER (morphine sulfate) extended-release (ER) tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Arymo ER is the first approved product developed using Egalets proprietary Guardian Technologya physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonistcreating tablets that are difficult to manipulate for the purpose of misuse and abuse.
Results from in vitro testing demonstrated that Arymo ER tablets, in comparison to non-abuse-deterrent morphine sulfate extended-release tablets, have increased resistance to cutting, crushing, grinding or breaking using a variety of tools. Due to its physical and chemical properties, Arymo ER is expected to make abuse by injection difficult.
Given the need for treatments for the millions of Americans living with chronic pain, the growing problem of prescription abuse and the fact that we know diversion is a huge problem, it is important that we have more abuse-deterrent treatment options, like Arymo ER, if and when these pain treatments end up in the wrong hands, said Nathaniel Katz, M.D., neurologist and pain specialist as well as founder and president of Analgesic Solutions.
Arymo ER has been approved in three dosage strengths: 15 mg, 30 mg and 60 mg. The U.S. commercial launch, utilizing Egalets established commercial infrastructure, is planned for the first quarter 2017.
With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools, said Bob Radie, president and chief executive officer of Egalet.
Arymo ER has physical and chemical properties expected to make abuse by injection difficult which is important given it is the most common non-oral route of morphine abuse and the most dangerous. With our commercial organization in place, we are ready to launch Arymo ER in the first quarter of 2017.
Guardian Technology
Egalets Guardian Technology has many applications and has been used to develop abuse-deterrent forms of commonly abused prescription medications.
Egalets proprietary Guardian Technology is a polymer matrix tablet technology that utilizes a novel application of the well characterized manufacturing process of injection molding, which results in tablets that are hard and difficult to manipulate for misuse and abuse. This approach offers the ability to design tablets with controlled-release profiles as well as physical and chemical properties that have been demonstrated to resist both common and rigorous methods of manipulation.
Tablets manufactured with Guardian Technology have been shown to have increased resistance to physical methods of manipulation, such as cutting, crushing, grinding or breaking using a variety of mechanical and electrical tools.
They are also resistant to chemical manipulation and attempts at extraction and turn into a viscous hydrogel on contact with liquid, making syringeability very difficult.
Source: drugs.com
