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Wednesday, September 09, 2015 5:30:07 PM
ACUR: Egalet Corporation Launches Acura Pharmaceuticals' OXAYDO(TM)
4:15 PM ET 9/9/15 | Marketwired
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), today announced that Egalet Corporation (NASDAQ: EGLT) has commercially launched in the United States OXAYDO (oxycodone HCI) tablets, a product Egalet licensed from Acura. OXAYDO, an immediate release oxycodone hydrochloride formulation that incorporates Acura's patented AVERSIONÂ? (abuse-deterrent) Technology, is indicated for the treatment of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. OXAYDO can be taken without regard to food, the way opioids generally are taken.
"We are excited that OXAYDO, for the first time, is being promoted to physicians by a pharmaceutical sales force," commented Bob Jones, President and CEO of Acura. "Our marketing partner, Egalet, has done a terrific job building their commercial infrastructure to make this launch happen."
Acura's AVERSION (abuse-deterrent) Technology is a patented mixture of gelling ingredients and nasal irritants designed to address common forms of opioid abuse.
Acura's license agreement with Egalet provides for a milestone payment of $2.5 million upon the first commercial sale of OXAYDO in the U.S., which Acura currently expects to receive in the fourth quarter of 2015, and an additional one-time payment of $12.5 million when annual world-wide net sales of OXAYDO first reach $150 million in a calendar year. Acura is also to receive a stepped royalty at percentage rates from mid-single digits to double digits based on the level of OXAYDO world-wide net sales in a calendar year (including any product line extensions). Royalties are payable on the first commercial sale of OXAYDO and expire, on a country-by-country basis, upon the expiration of Acura's patent in such country.
Important Safety Information for OXAYDO(TM) (oxycodone HCl, USP) Tablets for oral use only -- CII
OXAYDO 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.
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.
Respiratory depression is the primary risk of OXAYDO and it must be used with extreme caution in patients with chronic obstructive pulmonary disease or corpulmonale, in patients with decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression.
OXAYDO(TM) contains oxycodone HCl, an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. OXAYDO can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing in situations where there is concern about an increased risk of misuse or abuse. 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. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Patients should not consume alcoholic beverages, or any medications containing alcohol while taking OXAYDO.
OXAYDO may cause severe hypotension in patients whose ability to maintain blood pressure has been compromised. OXAYDO may produce orthostatic hypotension in ambulatory patients. OXAYDO must be administered with caution in patients in circulatory shock.
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.
In opioid naÃ?ve patients, start dosing OXAYDO with five to 15 mg every four to six hours as needed for pain. OXAYDO should not be given to anyone other than the individual for whom it was prescribed. Keep OXAYDO in a locked cabinet, drawer or medicine safe so that it will not be stolen.
Please see full prescribing information for OXAYDO at oxaydo.com.
About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX(TM), AVERSIONÂ? and IMPEDEÂ? Technologies. LIMITX contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.
On January 7, 2015, we entered into a Collaboration and License Agreement with Egalet US, Inc. and Egalet Ltd., each a subsidiary of Egalet, pursuant to which we licensed to Egalet worldwide rights to manufacture and commercialize OXAYDO.
Acura also markets NEXAFEDÂ? and NEXAFEDÂ? Sinus, which are pseudoephedrine containing products that utilize the IMPEDE Technology.
4:15 PM ET 9/9/15 | Marketwired
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), today announced that Egalet Corporation (NASDAQ: EGLT) has commercially launched in the United States OXAYDO (oxycodone HCI) tablets, a product Egalet licensed from Acura. OXAYDO, an immediate release oxycodone hydrochloride formulation that incorporates Acura's patented AVERSIONÂ? (abuse-deterrent) Technology, is indicated for the treatment of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. OXAYDO can be taken without regard to food, the way opioids generally are taken.
"We are excited that OXAYDO, for the first time, is being promoted to physicians by a pharmaceutical sales force," commented Bob Jones, President and CEO of Acura. "Our marketing partner, Egalet, has done a terrific job building their commercial infrastructure to make this launch happen."
Acura's AVERSION (abuse-deterrent) Technology is a patented mixture of gelling ingredients and nasal irritants designed to address common forms of opioid abuse.
Acura's license agreement with Egalet provides for a milestone payment of $2.5 million upon the first commercial sale of OXAYDO in the U.S., which Acura currently expects to receive in the fourth quarter of 2015, and an additional one-time payment of $12.5 million when annual world-wide net sales of OXAYDO first reach $150 million in a calendar year. Acura is also to receive a stepped royalty at percentage rates from mid-single digits to double digits based on the level of OXAYDO world-wide net sales in a calendar year (including any product line extensions). Royalties are payable on the first commercial sale of OXAYDO and expire, on a country-by-country basis, upon the expiration of Acura's patent in such country.
Important Safety Information for OXAYDO(TM) (oxycodone HCl, USP) Tablets for oral use only -- CII
OXAYDO 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.
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.
Respiratory depression is the primary risk of OXAYDO and it must be used with extreme caution in patients with chronic obstructive pulmonary disease or corpulmonale, in patients with decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression.
OXAYDO(TM) contains oxycodone HCl, an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. OXAYDO can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing in situations where there is concern about an increased risk of misuse or abuse. 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. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Patients should not consume alcoholic beverages, or any medications containing alcohol while taking OXAYDO.
OXAYDO may cause severe hypotension in patients whose ability to maintain blood pressure has been compromised. OXAYDO may produce orthostatic hypotension in ambulatory patients. OXAYDO must be administered with caution in patients in circulatory shock.
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.
In opioid naÃ?ve patients, start dosing OXAYDO with five to 15 mg every four to six hours as needed for pain. OXAYDO should not be given to anyone other than the individual for whom it was prescribed. Keep OXAYDO in a locked cabinet, drawer or medicine safe so that it will not be stolen.
Please see full prescribing information for OXAYDO at oxaydo.com.
About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX(TM), AVERSIONÂ? and IMPEDEÂ? Technologies. LIMITX contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.
On January 7, 2015, we entered into a Collaboration and License Agreement with Egalet US, Inc. and Egalet Ltd., each a subsidiary of Egalet, pursuant to which we licensed to Egalet worldwide rights to manufacture and commercialize OXAYDO.
Acura also markets NEXAFEDÂ? and NEXAFEDÂ? Sinus, which are pseudoephedrine containing products that utilize the IMPEDE Technology.
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