Lancaster, PA, February 8, 2016: Septodont, the world’s largest manufacturer of dental anesthetics signed an agreement with Egalet Corporation, a specialty pharmaceutical company, for exclusive marketing rights to promote SPRIX® (ketorolac tromethamine) Nasal Spray to the dental market in the US.
SPRIX Nasal Spray is indicated as an alternative to opioid or steroid therapy. It is a short term – maximum 5-day treatment for adults to manage moderate to moderately severe pain that would require analgesia at the opioid level. For full prescribing information on SPRIX Nasal Spray, including Boxed Warning, please visit sprix.com.
About Septodont: For over 80 years Septodont has been a global influence in manufacturing dental materials and local anesthetics for the dental community. Today they are a leader in pain management with a presence in over 150 countries with regulatory approvals to match. Septodont has 8 manufacturing facilities on 4 continents; Canada, United States, India, France (3) Brazil (2). For more information, visit www.septodont.com
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. Eaglet’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.
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.
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