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Egalet Announces Filing of Supplemental New Drug Application for OXAYDO® to FDA

08:54 EST 1 Dec 2016 | PR Newswire

WAYNE, Pa., Dec. 1, 2016 /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, today announced that the company has submitted to the U.S. Food and Drug Administration (FDA) a supplemental new drug application (sNDA) for OXAYDO® (oxycodone HCl, USP) tablets C-II to support an abuse-deterrent label claim for the intravenous route of abuse.  The sNDA includes Category 1 in vitro data that demonstrate OXAYDO resists extraction of oxycodone and, based on its gelling properties, is more difficult to draw into a syringe compared to a non-abuse-deterrent immediate-release (IR) oxycodone comparator. OXAYDO is an IR oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Immediate-release opioids account for 90 percent of the total U.S. opioid market. An estimated 91 percent of all prescription opioid abusers have abused immediate-release opioids. There are currently no abuse-deterrent, IR opioids on the market today.

"The submission of this supplemental NDA for OXAYDO is part of our broader strategy to strengthen and expand the label for OXAYDO," said Jeffrey Dayno, MD, chief medical officer at Egalet. "With the issue of abuse of immediate-release opioids receiving more attention recently, we look forward to working with the FDA as they review the data submitted in this supplement."

OXAYDO is the first and only immediate-release oxycodone product designed to discourage intranasal abuse. Through its novel, patent protected formulation, OXAYDO contains an inactive ingredient that may cause nasal burning if OXAYDO is manipulated and snorted. In an intranasal human abuse potential double-blind, crossover study, six times more recreational users reported they would not take OXAYDO again compared to subjects exposed to immediate-release oxycodone (30 percent of subjects exposed to OXAYDO responded they would not take the drug again compared to five percent of subjects exposed to IR oxycodone). The clinical significance of the difference in drug liking and difference in response to taking the drug again reported in this study has not yet been established. There is no evidence that OXAYDO has reduced abuse liability compared to immediate-release oxycodone.

The sNDA for OXAYDO includes data from a series of Category 1 studies that were presented at PAINWeek 2016. The sNDA will be a standard FDA review which carries a six-month review timeline.

About EgaletEgalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has two approved products: OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using its proprietary Guardian™ Technology, Egalet is developing a pipeline of clinical-stage, product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO™ ER, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are being developed 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. Egalet's 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 additional information on Egalet, please visit egalet.com. For full prescribing information on SPRIX, including the boxed warning, please visit sprix.com. For full prescribing information on OXAYDO, please visit oxaydo.com.

Important Safety Information for OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CIIIndications and Usage
OXAYDO (oxycodone HCl, USP) is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Contraindications
OXAYDO is contraindicated in patients with respiratory depression, paralytic ileus, acute or severe bronchial asthma or hypercarbia, or known hypersensitivity to oxycodone or any components of the product, or in any situation where opioids are contraindicated.

Warnings and PRECAUTIONS
Respiratory depression is a risk of OXAYDO, especially in elderly or debilitated patients, in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients, or when given in conjunction with other agents that depress respiration. Use with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale.

OXAYDO is a Schedule II controlled substance with an abuse liability similar to other opioids. OXAYDO may be abused by crushing, chewing, snorting or injecting the product and these practices pose a significant risk to the abuser that could result in overdose and death.

Patients receiving central nervous system depressants concomitantly with OXAYDO may exhibit an additive central nervous system depression, which may result in respiratory depression, hypotension, profound sedation, or coma. Patients should not consume alcoholic beverages, or any medications containing alcohol while taking OXAYDO.

In the presence of a head injury or other intracranial lesions, OXAYDO may cause markedly exaggerated elevation of intracranial pressure.

OXAYDO may cause severe hypotension in patients whose ability to maintain blood pressure has been compromised, may produce orthostatic hypotension in ambulatory patients and must be administered with caution in patients in circulatory shock.

Do not administer OXAYDO to patients with gastrointestinal obstruction. Use OXAYDO with caution in patients with biliary tract disease, including pancreatitis.

Use with caution and in reduced dosages in patients with severe renal or hepatic impairment, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients.  Use with caution when administering to patients with CNS depression, toxic psychosis, acute alcoholism and delirium tremens; may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings.

Keep OXAYDO out of the reach of children.

OXAYDO may impair mental and/or physical abilities; use with caution with potentially hazardous activities.

Concomitant use of CYP3A4 inhibitors may increase opioid effects and of CYP3A4 inducers may decrease effects or possibly cause development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone.

Adverse Reactions
Serious adverse reactions that may be associated with OXAYDO include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.

The most common adverse reactions are nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia and somnolence.

Additional Drug Interactions
Muscle relaxants: enhances the neuromuscular blocking action of skeletal muscle relaxants and produces an increased degree of respiratory depression.

Mixed agonist/antagonist analgesics: may reduce the analgesic effects and/or may precipitate withdrawal symptoms.

Monoamine Oxidase Inhibitors (MAOIs): use not recommended with or within 14 days of stopping MAOIs.

Anticholinergics: increased risk for urinary retention and severe constipation.

Safe HarborStatements included in this press release (including but not limited to anticipated labeling for ARYMO ER) 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 Egalet's clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; Egalet's ability to obtain regulatory approval of its 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 service its debt obligations; Egalet's ability to raise additional funds related to execute its business plan and growth strategy in terms acceptable to Egalet, if at all; Egalet's ability to find and hire qualified sales professionals; the 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; general market conditions; and other risk 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.

Investor and Media Contact: E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 917-432-9275

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SOURCE Egalet Corporation

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