WAYNE, Penn., March 25, 2014 (GLOBE NEWSWIRE) -- Egalet Corporation (Nasdaq:EGLT) ("Egalet") today announced the initiation of the bioequivalence (BE) program for Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the treatment of moderate to severe chronic pain. These studies are intended to establish bioequivalence of Egalet-001 to MS Contin® (morphine sulfate controlled-release) ("MS Contin").
The bioequivalence program consists of three studies, all examining the bioequivalence of Egalet-001 compared to MS Contin.
"In parallel with the BE studies, we are conducting studies consistent with the FDA draft guidance to establish Egalet-001's abuse-deterrent properties, with the goal of obtaining abuse-deterrent claims in our product label," said Bob Radie, Egalet's president and chief executive officer. "We are working to make these important medicines available to patients who are suffering with chronic pain, but do it in a safer and more responsible way to limit the issues of abuse and misuse, with products like Egalet-001."
Egalet plans to seek approval of Egalet-001 under the FDA's Section 505(b)(2) regulatory pathway, and has received Fast Track designation for Egalet-001 which could afford greater access to the FDA for the purpose of expediting Egalet-001's development, review and potential approval. Egalet intends to rely on the FDA's previous conclusions of safety and efficacy for MS Contin, and does not expect that any additional preclinical studies or clinical trials will be required for Egalet-001. Egalet anticipates submitting an NDA in the fourth quarter of 2014 and if approved by the FDA, commencing sales and marketing of the product in the second half of 2015.
Egalet's lead product candidate, Egalet-001, is an abuse-deterrent, extended-release (ER), oral morphine formulation. Egalet-001 utilizes the company's proprietary one-component system, which allows the development of customized ER profiles. Egalet-001 consists of an approved and well-characterized drug substance, morphine sulfate, together with inactive ingredients deemed safe for chronic oral use. Morphine-based products, including MS Contin, have been available in the U.S. market for many years and have a well-established safety profile. All ingredients in Egalet-001 are present in approved drug products on the U.S. market. Egalet is developing Egalet-001 for administration two to three times a day.
Egalet Corporation is a specialty pharmaceutical company developing and planning to commercialize proprietary, abuse-deterrent oral products for the treatment of pain and other indications. Egalet has created two distinct drug delivery systems, each with novel abuse-deterrent features and the ability to control the release profile of the active pharmaceutical ingredient. Using its proprietary platform, Egalet has developed a pipeline of clinical-stage, opioid-based product candidates in tablet form that are specifically designed to deter abuse by physical and chemical manipulation, while also providing tailored release of the active pharmaceutical ingredient. Its lead product candidate, Egalet-001, is an abuse-deterrent, extended-release, oral morphine formulation in development for the treatment of moderate to severe chronic pain. There are currently no commercially available abuse-deterrent formulations of morphine, and if approved, Egalet believes that Egalet-001 would fill a significant unmet need in the marketplace. Its second product candidate, Egalet-002, is an abuse-deterrent, extended-release, oral oxycodone formulation in development for the treatment of moderate to severe chronic pain. The Egalet 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. Visit www.egalet.com for more information.
Statements included in this press release that are not historical in nature 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: the success of our clinical trials; our ability to obtain regulatory approval of our product candidates; competitive factors; general market conditions; and other risks factors described in Egalet's filings with the United States Securities and Exchange Commission. Egalet assumes no 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.