Panel of Leading Pain Management Specialists Highlight Potential Role of Abuse-Deterrent Formulations of Opioids and Non-Narcotics to Help Curb Misuse and Abuse at Egalet Investor Day
May 11, 2017
WAYNE, Pa., May 11, 2017 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, hosted a panel discussion as part of its investor event on May 10, 2017, featuring three leading pain management specialists. The panelists discussed the challenges of treating patients with pain, the expected/potential advantages of prescribing abuse-deterrent formulations (ADFs) of opioids, and the role ADFs and non-narcotic treatment options could play in helping to curb the epidemic of opioid misuse and abuse.
"There are so many patients that you don't even know how [opioid] abuse is going to manifest itself," said Richard Rauck, M.D., founder of the Carolinas Pain Institute. "Whether they are selling their home and somebody comes to the open house and gets into their medicine cabinet, or kids steal opioids out of a medicine cabinet or maybe out of a car, there are so many ways these drugs can end up in the wrong hands. So we can change that discussion to get all, in particular the long-acting [opioids], in abuse-deterrent formulations."
The panel, which was moderated by Egalet medical director Colville Brown, M.D. and included Jeffrey Fudin, Pharm D., adjunct associate professor, Albany College of Pharmacy and Health Sciences; Jeffrey Goldstein, D.O., founder and director of Fountain Medical Group; and Dr. Rauck, discussed a range of topics from how to treat individuals living with pain to where Egalet's products, ARYMO® ER (morphine sulfate) extended-release tablets for oral use only –CII, developed using Egalet's proprietary Guardian™ Technology, OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX® (ketorolac tromethamine) Nasal Spray, can play a role.
As part of the investor event, Egalet's management team provided an overview of the company's commercial business, regulatory and clinical updates, and reported first quarter 2017 earnings.
Highlights from investor day include:
- Established commercial foundation and have grown demand for SPRIX Nasal Spray and OXAYDO over last eight quarters;
- To maximize the commercial opportunity for all three products, deployed 82 territory managers in two teams at the end of the first quarter in conjunction with ARYMO ER launch;
- Initial positive feedback from target healthcare providers on profile of ARYMO ER, which was approved by the U.S. Food and Drug Administration (FDA) on January 9, 2017 and launched at the end of the first quarter;
- Market access team is targeting select commercial insurers to overcome barriers and laying the ground work for Medicare and Medicaid access in the future;
- Potential to expand commercial opportunity for OXAYDO with prior approval supplement for OXAYDO 10 and 15 mg dosage strengths, which was filed in February of 2017, and supplemental NDA to strengthen the label with abuse-deterrent label that shows OXAYDO resists syringeability;
- Focused on commercial execution in 2017 and making necessary tradeoffs to maximize resources;
- Egalet-002 phase 3 program to be completed in the fourth quarter of 2017, but additional expense postponed; and
- To continue to grow, Egalet continues to evaluate in-licensing opportunities, contemplate partnerships to co-promote SPRIX and consider opportunities to leverage Guardian Technology.
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 only –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 is developing a pipeline of clinical-stage, product candidates 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. For additional information on Egalet, please visit egalet.com.
Statements included in this press release 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," "focused on" and other similar expressions are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which include plans to target commercial insurers and to seek Medicare and Medicaid access, the potential addition of new OXAYDO dosage strengths and a strengthened OXAYDO label, the execution of Egalet's commercialization plan in 2017 and taking steps to maximize Egalet's resources, 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 obtain regulatory approval of its product candidates, its regulatory filings and the labeling claims that Egalet believes are necessary or desirable for successful commercialization of its products and product candidates; Egalet's ability to maintain the intellectual property position of its 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 which compete with Egalet's that are or become available; the success of Egalet's clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; general market conditions; and the 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. In addition, the forward-looking statements included in this press release represent Egalet's views only as of the date hereof. Egalet anticipates that subsequent events and developments may cause its views to change. 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.
Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
SOURCE Egalet Corporation