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Novel Development of IR Oxycodone HCl Tablets with Aversion ® Technology Kenneth W Sommerville MD Vice President, Clinical Research Robert Rolleri Pharm D Senior Director, Clinical Research King Pharmaceuticals March 6, 2009
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2 Disclosures Drs Sommerville and Rolleri are full-time employees of King Pharmaceuticals and own stock in the company The development of Acurox ® Tablets has been supported by Acura Pharmaceuticals and King Pharmaceuticals
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3 Acurox ® and Aversion ® Technology Aversion ® Technology is a patented platform for developing pharmaceutical products containing drugs of potential abuse, including oxycodone and other opioid analgesics. Acurox ® is a short-acting, immediate-release tablet formulation of oxycodone HCl developed with Aversion ® Technology The two active ingredients: –Oxycodone HCl for relief of moderate to severe pain –Niacin to deter excess oral consumption Also contains essential functional inactive ingredients
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4 Acurox ® Clinical Program Ten clinical studies Three pharmacokinetic Three for niacin dosing One for efficacy/safety Three abuse liability Multiple laboratory studies Oxycodone extraction tests using independent non-affiliated labs Syringeability tests
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5 Acurox ® Results of Study 105: Patient Disposition 33% SCREEN FAILURE Patients Screened (N = 606) Placebo N = 136 Withdrawals N = 8 RX Failure (3) Withdrew Consent (3) Non Compliance (1) Lost to FU (1) Patients Randomized (N = 405) Acurox ® 5/30 N = 135 Acurox ® 7.5/30 N = 134 Withdrawals N = 8 Adverse Event (2) RX Failure (1) Withdrew Consent (4) Non Compliance (1) Withdrawals N = 5 Adverse Event (4) Other (1)
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6 N=136N=134N=135 P = 0.0001 vs. placebo P = <0.0001 vs. placebo Acurox ® Results: Pivotal Efficacy/Safety Trial (Study 105) Primary Efficacy Endpoint (SPID 48 ) millimeters
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7 Acurox ® Safety in Study 105 Six patients (2.2%) withdrew for adverse events compared to 0% on placebo. The most common adverse events with Acurox ® were nausea, vomiting, dizziness, pruritus, and flushing. Most adverse events were mild or moderate and there were no serious adverse events.
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8 Abuse Liability Studies of Acurox ® Three studies were performed –Two for oral abuse –One for nasal abuse (snorting) Subjects were non-opioid dependent past or current opioid users The oral abuse studies showed: –Response to niacin 240 mg alone compared to placebo causes significant dislike scores (p =.03) –The combination of oxycodone HCl 40mg and niacin 240mg (4 times the expected recommended dose of two Acurox ® Tablets 5/30mg) have the potential to be aversive when compared to oxycodone HCl 40mg alone as shown by statistically significant and clinically meaningful results in the dislike/like scores (p =.033), The nasal (snorting) study results are to be released later in 2009.
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9 Acurox ® Clinical Summary Demonstrated to be effective and well-tolerated in a post-operative model (bunionectomy) of moderate to severe pain. The combination of oxycodone/niacin is well tolerated at ratios of 5/30 and 7.5/30. Drug-disliking demonstrated for doses 4X recommended at 0.5 hours after ingestion. Nasal snorting study results to be reported later this year. NDA Submitted Dec. 30, 2008
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10 LAUGHING AT PHARMA New York: New Yorker and Pharmaceutical Publication, 2004 Artist Peter Steiner
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