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Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing, and commercializing innovative treatments for pain and other conditions, announced Category 1 abuse-deterrent data to demonstrate that OXAYDO (oxycodone HCl, USP) tablets CII resist syringeability, which could potentially prevent abuse through the intravenous route.
The data from a series of Category 1 studies of syringeability, which assess abuse deterrence through the intravenous route of administration, showed that OXAYDO forms a highly viscous gel that resisted preparation for injection and attempts to isolate oxycodone after manipulation. These outcomes imply that OXAYDO presents significant barriers to abuse via the intravenous route of administration. The data also proved that the extraction of oxycodone from OXAYDO was significantly more difficult than from the comparator—a marketed generic immediate-release oxycodone.
OXAYDO is an immediate-release oral formulation of oxycodone HCl indicated to manage acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. OXAYDO is intended to discourage intranasal abuse through its novel, patent protected formulation. The product has an inactive ingredient that may cause nasal burning if OXAYDO is manipulated and snorted.
In an intranasal human abuse potential double-blind, crossover research, six times more recreational users reported they would not take OXAYDO again compared to subjects exposed to immediate-release oxycodone (30 percent of subjects exposed to OXAYDO responded they would not take the drug again compared to five percent of subjects exposed to IR oxycodone). The clinical significance of the difference in drug liking and difference in response to taking the drug again reported in this research has not yet been established. There is no evidence that OXAYDO has reduced abuse liability than immediate-release oxycodone.
Significant Safety Information for OXAYDO
Indications
OXAYDO (oxycodone HCl, USP) is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the utilization of an opioid analgesic is appropriate.
Contraindications
OXAYDO is contraindicated in people with respiratory depression, paralytic ileus, acute or severe bronchial asthma or hypercarbia, or known hypersensitivity to oxycodone or any elements of the product, or in any situation where opioids are contraindicated.
Use of Oxaydo: Warnings and Precautions
Respiratory depression is a risk of OXAYDO, particularly in elderly or debilitated patients, in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients, or when given in conjunction with other agents that depress respiration. Use with extreme caution in persons with chronic obstructive pulmonary disease.
OXAYDO is a Schedule II controlled substance with an abuse liability the same to other opioids. OXAYDO may be abused by crushing, chewing, snorting, or injecting the product, and these practices pose a significant risk to the abuser that could lead to overdose and death.
Patients receiving central nervous system depressants concomitantly with OXAYDO may exhibit an additive central nervous system depression, which may lead to respiratory depression, hypotension, profound sedation, or coma. Patients should not take alcoholic beverages or any medications containing alcohol while taking OXAYDO.
In the presence of a head injury or other intracranial lesions, OXAYDO may cause significantly exaggerated elevation of intracranial pressure.
OXAYDO may cause serious hypotension in patients whose ability to maintain blood pressure has been compromised, may produce orthostatic hypotension in ambulatory patients, and must be administered with caution in patients in circulatory shock.
Don’t administer OXAYDO to patients with gastrointestinal obstruction. Use OXAYDO with caution in patients with biliary tract disease, as well as pancreatitis.
Use with caution and in reduced dosages in people with severe renal or hepatic impairment, Addison’s disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients. Use with caution when administering to patients with central nervous depression, toxic psychosis, acute alcoholism, and delirium tremens; may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings.
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