Rexista is a unique dosage form, designed to be resistant to well-documented abuse that is experienced with current oxycodone products. This includes.
Due to the growing abuse associated with certain painkillers, in April 2011, the FDA announced the requirement of an Opioids Risk Evaluation and Mitigation Strategy (REMS) as part of a broader action plan to address the national prescription drug abuse epidemic in the U.S.
Our initial pilot clinical trial of Rexista was designed to compare the pharmacokinetic characteristics of our oxycodone product, in a once-a-day 40mg dosage format, with a currently marketed branded oxycodone product, Purdue Pharma's OxyContin, in a twice-a-day 20mg dosage format, under fasted conditions.
This includes abuse by injection when combined with solvents and by nasal inhalation when crushed or powdered.
DOSAGE AND ADMINISTRATION. Oxycodone hydrochloride tablets are intended for the management of moderate to severe pain in patients who require.
Gut 2002; 51: 275–80. Letter: effects of oxycodone and tapentadol dosage on gastrointestinal function. M. Kim & G. Vorsanger. Janssen Scientific Affairs, LLC.