PRNewswire 17-Apr-2018 4:02 PM
WAYNE, Pa., April 17, 2018
WAYNE, Pa., April 17, 2018 /PRNewswire/ -- 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 two large Northeast regional health plans have placed ARYMO® ER (morphine sulfate) extended-release (ER) tablets for oral use only –CII in a preferred formulary position effective immediately.
"Obtaining preferred coverage from two large Northeast regional plans that cover nearly a million member lives is a critical step to broadening access to ARYMO ER for those who might need this treatment option," said Patrick Shea, chief commercial officer of Egalet. "We believe that payers are recognizing the need to include abuse-deterrent opioids as a part of the multifaceted approach required to address the prescription opioid abuse crisis in our communities."
Please see safety information on ARYMO ER, including the boxed warning and medication guide below. Abuse of ARYMO ER by injection, as well as by the oral and nasal routes, is still possible. For full prescribing information for ARYMO ER, please visit arymoer.com.
IMPORTANT SAFETY INFORMATION ABOUT ARYMO ER
WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING
Addiction, Abuse, and Misuse
Life-Threatening Respiratory Depression
Neonatal Opioid Withdrawal Syndrome
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
ARYMO® ER (AIR i mow) (morphine sulfate) extended-release tablets, CII
ARYMO ER is:
Important information about ARYMO ER:
Do not take ARYMO ER if you have:
Before taking ARYMO ER, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
When taking ARYMO ER:
While taking ARYMO ER DO NOT:
The possible side effects of ARYMO ER are:
Get emergency medical help if you have:
These are not all the possible side effects of ARYMO ER. Call your doctor for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Egalet US Inc. at 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has three approved products: ARYMO® ER (morphine sulfate) extended-release tablets for oral use —CII, developed using Egalet's proprietary Guardian™ Technology, OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII and SPRIX® (ketorolac tromethamine) Nasal Spray. Using Guardian Technology, Egalet has developed a pipeline of clinical-stage, product candidates for which we are seeking partners including Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation 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. Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles.
For full prescribing information on ARYMO ER, including the boxed warning and medication guide, please visit arymoer.com. For full prescribing information on SPRIX, including the boxed warning and medication guide, please visit sprix.com. For full prescribing information on OXAYDO, including the boxed warning and medication guide, please visit oxaydo.com.
Statements included in this press release (including but not limited to upcoming milestones) that are not historical in nature and contain the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "look forward to" and other similar expressions are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and are subject to known and unknown uncertainties and risks. Actual results could differ materially from those discussed due to a number of factors, including, but not limited to: Egalet's ability to continue as a going concern; Egalet's ability to remain listed on the Nasdaq; the potential impact of strengthening the ARYMO ER label; the success of Egalet's clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; Egalet's ability to obtain and maintain regulatory approval of Egalet's products and product candidates and the labeling claims that Egalet believes are necessary or desirable for successful commercialization of its products and product candidates; the impact of strengthening any of the labels for Egalet's products; Egalet's ability to maintain the intellectual property position of Egalet's products and product candidates; Egalet's ability to identify and reliance upon qualified third parties to manufacture its products; Egalet's ability to commercialize its products, and to do so successfully; the costs of commercialization activities, including marketing, sales and distribution; the size and growth potential of the markets for Egalet's products and product candidates, and Egalet's ability to service those markets; Egalet's ability to obtain reimbursement and third-party payor contracts for its products; Egalet's ability to service its debt obligations; Egalet's ability to raise additional funds to execute its business plan and growth strategy on terms acceptable to Egalet, if at all; Egalet's ability to find and hire qualified sales professionals; the rate and degree of receptivity in the marketplace and among physicians to Egalet's products; the success of products that compete with Egalet's that are or become available; the regulatory environment and social concerns about limiting the use of opioids; general market conditions; and other risk factors set forth in Egalet's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in other filings Egalet makes with the SEC from time to time. While Egalet may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by law.
Media and Investor Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
SOURCE Egalet Corporation
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