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Egalet Deploys Salesforce to Begin Educating Healthcare Providers about ARYMO(TM) ER
6:02 am ET March 30, 2017 (PR Newswire) Print

Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today announced that one of the company's specialty sales forces has begun promotion of ARYMO(TM) ER (morphine sulfate) extended-release tablets for oral use only -CII. Egalet executives will commemorate the product's official launch by ringing the Nasdaq Stock Market closing bell today.

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ARYMO ER was approved by the U.S. Food and Drug Administration (FDA) on January 9, 2017 in three dosage strengths: 15 mg, 30 mg and 60 mg, and is indicated 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.

"It is critical that we provide those living with chronic pain access to effective analgesics, and create barriers to prescription drug misuse and abuse should these pain medications end up in the wrong hands," said Jeffrey Dayno, chief medical officer of Egalet. "With over 98% of the extended-release morphine products on the market in easy to abuse forms, healthcare providers will now have a new treatment option, ARYMO ER, that has increased resistance to cutting, crushing, grinding or breaking--often a first step in misuse and abuse."

ARYMO ER is the first approved product developed using Egalet's proprietary Guardian(TM) Technology--a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist--creating 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. Abuse of ARYMO ER by injection, as well as by the oral and nasal routes, is still possible.

"Now with ARYMO ER stocked at key wholesale distribution locations and having begun discussions with payers, our salesforce is well positioned to begin educating healthcare providers about the risks and benefits of ARYMO ER," said Bob Radie, president and chief executive officer of Egalet. "ARYMO ER strengthens our portfolio of pain products which includes SPRIX(R) Nasal Spray and OXAYDO(R)."

Nasdaq Closing Bell

To recognize the commercial launch of ARYMO ER, Egalet employees will join Mr. Radie as he rings the Nasdaq closing bell today. The event will be livestreamed at: https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx

For important safety information about ARYMO ER, please see below and for complete prescribing information, including the boxed warnings and medication guide, go to arymoer.com.

For full prescribing information on SPRIX(R) (ketorolac tromethamine) Nasal Spray and OXAYDO(R) (oxycodone HCI, USP) tablets for oral use only -CII, including the boxed warnings and medication guide, please go to sprix.com and oxaydo.com, respectively.

Guardian(TM) Technology Egalet's Guardian Technology has many applications and has been used to develop abuse-deterrent forms of commonly abused prescription medications. Egalet's 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.