Egalet Signs Agreement with Septodont, Inc. to Promote SPRIX® (ketorolac tromethamine) Nasal Spray to Dentists in United States

--Data published in Postgraduate Medicine supports use of SPRIX Nasal Spray as effective non-opioid option post dental procedures--

Feb 08, 2016, 06:00 ET from Egalet Corporation

WAYNE, Pa., Feb. 8, 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 a collaboration agreement with Septodont, Inc., a company dedicated to providing innovative pharmaceutical products to the dental profession. Under this agreement Septodont will promote SPRIX (ketorolac tromethamine) Nasal Spray exclusively to dentists in the United States using its focused specialty sales force. Under the terms of the agreement, Egalet will receive an upfront licensing fee, earn sales-based milestones and share in profits from net sales of SPRIX to dentists in the U.S.

"Through our partnership with Septodont, we are able to broaden our commercial reach bringing SPRIX Nasal Spray to dentists," said Bob Radie, president and chief executive officer of Egalet. "Given the data published in Postgraduate Medicine that supports the use of SPRIX Nasal Spray as a potent non-opioid option to treat short-term pain following dental procedures, dentists should welcome this effective treatment option for their patients."

This is the second partnership Egalet has entered to expand the commercial access of SPRIX Nasal Spray. Previously Egalet signed an agreement with Teva to market SPRIX Nasal Spray in select territories outside of the United States. Egalet will continue to seek relationships with companies to expand patient access to SPRIX Nasal Spray and its other pain products.

SPRIX Nasal Spray is a non-steroidal anti-inflammatory drug (NSAID) indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. For full prescribing information on SPRIX, including the Boxed Warning, please visit sprix.com.

A paper titled, "Effect size comparison of ketorolac nasal spray and commonly prescribed oral combination opioids for pain relief after third molar extraction Surgery," by Gwendolyn Niebler, D.O, senior vice president, clinical development and medical affairs, and Jeffrey Dayno, M.D., chief medical officer, at Egalet was published online in the December 2015 issue of Postgraduate Medicine.

About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. The Company has two approved products: OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using Egalet's proprietary Guardian™ Technology, the Company is developing a pipeline of clinical-stage, opioid-based product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO™ ER, formerly known as Egalet-001, 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 opioid treatment and for which alternative treatments 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. Full 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.

About Septodont
Septodont has focused on the development, manufacturing and distribution of dental pharmaceuticals and devices world-wide for over 80 years. A global leader in cartridge manufacturing, producing over 500 million dental anesthetic cartridges annually in North America and Europe, Septodont is the premier pain management company in dentistry.  The Company has eight manufacturing sites on four continents, and a long-established presence in more than 150 countries. For additional information about Septodont please visit www.septodont.com.

Important Safety Information for SPRIX® (ketorolac tromethamine) Nasal Spray SPRIX is a non-steroidal anti-inflammatory drug (NSAID) indicated in adult patients for the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

WARNING: LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK

See full prescribing information for complete boxed warning.

Limitations of Use

The total duration of use of SPRIX and other ketorolac formulations should not exceed 5 days. SPRIX is not indicated for use in pediatric patients and it is not indicated for minor or chronic painful conditions.

Gastrointestinal (GI) Risk 

Ketorolac can cause peptic ulcers, GI bleeding, and/or perforation of the stomach or intestines, which can be fatal. SPRIX is CONTRAINDICATED in patients with peptic ulcer disease or history of GI bleeding. Elderly patients are at greater risk for serious gastrointestinal events.

Bleeding Risk
SPRIX inhibits platelet function and is CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding.

Cardiovascular (CV) Risk
NSAIDs may cause an increased risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk. (5.6)  SPRIX is CONTRAINDICATED for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Renal Risk

SPRIX is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.

SPRIX is also contraindicated as a prophylactic analgesic before any surgery; for use in labor and delivery; for use in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; and, with known hypersensitivity to ketorolac, aspirin, other NSAIDs or EDTA. 

SPRIX should be used with caution in patients taking diuretics or ACE inhibitors, or those with compromised cardiac function.  NSAIDs can cause serious anaphylactoid reactions and serious dermatologic adverse reactions; SPRIX should be discontinued immediately in patients with allergic reactions or skin reactions. Starting at 30 weeks gestation, SPRIX can cause fetal harm when administered to a pregnant woman due to an increased risk of premature closure of the ductus arteriosus. If SPRIX is used at or after 30 weeks gestation, the patient should be apprised of the potential hazard to a fetus.

The most common adverse reactions (incidence > 2%) in patients treated with SPRIX and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis.

Please see full prescribing information, including Boxed Warning, for SPRIX at sprix.com.

Safe Harbor
Statements included in this press release (including but not limited to upcoming milestones) 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 Egalet's product candidates; 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 service its debt obligations; 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 for Egalet:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 917-432-9275

For additional information about Septodont contact:
Christopher LoSardo
Vice President of Business Development
Email: closardo@septodont.com 
Tel: 516-639-5643

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SOURCE Egalet Corporation



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