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 it has partnered with OraPharma, Inc., a division of Valeant Pharmaceuticals International, Inc., to co-promote SPRIX (ketorolac tromethamine) Nasal Spray to dentists, dental specialists and oral surgeons across the United States.
SPRIX Nasal Spray is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the short-term (up to five days in adults) management of moderate to moderately severe pain that requires analgesia at the opioid level.
"Given the need for additional non-narcotic analgesics in the dental space, we believe SPRIX Nasal Spray offers an attractive product profile that can complement the OraPharma line of oral health products," said Mark Strobeck, Ph.D., chief operating officer. "This partnership, which expands our commercial reach, represents one aspect of our business development strategy which also includes acquisition of late-stage or approved assets and out-licensing of our Guardian Technology pipeline product candidates."
OraPharma will begin promoting SPRIX in the first quarter as part of a two-year agreement. Financial terms of the agreement will not be disclosed. Egalet has terminated its agreement with Septodont.
Please see below for Important Safety Information on SPRIX Nasal Spray. For full prescribing information, including the Boxed Warning and Medication Guide, please visit sprix.com.
PRIX is contraindicated in the following patients:
- Known hypersensitivity to ketorolac or any components of the drug product.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
- In the setting of coronary artery bypass graft (CABG) surgery.
- Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.
- Use as a prophylactic analgesic before any major surgery.
- Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.
- Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
- Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical.
- Concomitant use with probenecid or pentoxifylline.
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 —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 for which we are seeking partners 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.