Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments, today announced the launch of OXAYDO™ (oxycodone HCI, USP) tablets -CII in the United States. OXAYDO is an immediate-release (IR) 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 the first and only IR oxycodone that is designed to discourage abuse via the route of snorting. OXAYDO can be taken without regard to food, the way opioids generally are taken.
"Now with OXAYDO available, physicians will have an immediate-release oxycodone option that's designed to discourage abuse with no food effect," said Deanne Melloy, Egalet's chief commercial officer. "Our dedicated sales force will begin promoting OXAYDO immediately in addition to promoting SPRIX®, a nasal spray form of ketorolac, to healthcare providers focused on pain."
According to the CDC nearly 11 million people reported using opioids non-medically in the past year and abuse often begins with a legitimate prescription. Adding to the complexity for the prescriber, is the fact that almost 70% of abused opioids are taken from a friend or relative according to the 2013 National Survey on Drug Use and Health. There were approximately 15.8 million oxycodone single-agent IR prescriptions dispensed in 2014. In the five-years following the approval of reformulated extended-release oxycodone, there was a 50 percent increase in the use of oxycodone IR. Nonmedical users of opioids often prefer oxycodone—one of the most frequently abused single-agent opioids. Snorting is among the most commonly reported routes in which IR, single-agent oxycodone is abused.
OXAYDO is designed to discourage intranasal abuse through its novel, patent protected formulation. The product contains an inactive ingredient that may cause nasal burning if OXAYDO is manipulated. In a double-blind, crossover study 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 study has not yet been established. There is no evidence that OXAYDO has reduced abuse liability compared to immediate-release oxycodone.
"Because single-agent, IR oxycodone is one of the most frequently abused opioids, OXAYDO is an important addition to our arsenal of treatment options to help patients manage their pain while discouraging abuse," said Sri Nalamachu, MD, president and medical director, International Clinical Research Institute. "Because we know prescription opioids often end up in the wrong hands and since OXAYDO™ is the first and only IR oxycodone designed to discourage intranasal abuse, OXAYDO should be considered when an immediate release opioid is needed."
Egalet is committed to patient access across all of its commercial products and is announcing the launch of IMPACT-Rx, IMproving Patients ACcess To Medicines, initiative. The IMPACT-Rx initiative will be applied to each of our commercial products to ensure that virtually no barrier exists to patients gaining access to critical medicines they need. This national initiative will employ three key features: reimbursement support, easier access to fill a prescription and patient education. As part of this initiative, we have established the My OXAYDO Patient Savings Program.
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