Purdue debuts opioid-abuse resource
Purdue Pharma launched a new website, teamagainstopioidabuse.com, in a bid to educate healthcare providers and patients about abuse-deterrent opioid-based painkillers.
Purdue markets two of the three opioid painkillers available with abuse-deterrent properties: Hysingla ER and OxyContin. Pfizer makes the third drug, Embeda.
The website is aimed at people across the healthcare spectrum: pharmacists, caregivers, counselors, nurses, patients and payers. It features a doctor with eye black and encourages visitors to the site to “step up their game” with “opioids with abuse-deterrent properties.”
“This is where the opioid market is going,” Dr. J. David Haddox, VP of health policy for Purdue Pharma, told MM&M. “We believe the FDA and ONDCP (Office of National Drug Control Policy) see [abuse-deterrent opioids] as a piece of a larger comprehensive approach to opioid abuse. We thought it'd be helpful to understand more about them and the type of technology that goes into them.”
The site's sports tone and imagery, Haddox said, was what physicians, pharmacists and nurses ranked the highest during market research. “The concept is that we're all part of a team,” he noted. Razorfish Health is Purdue's agency of record.
The online portal also emphasizes the role each healthcare stakeholder plays in reducing opioid abuse and draws attention to the responsibility of pharmacists, payers, patients and parents to help reduce the prescription opioid-abuse problem, the site said.
The FDA approved an abuse-deterrent formulation of OxyContin in 2010. When crushed, the pill turns into a gel rather than a powder, which makes it difficult to be injected or snorted. Overdose deaths involving opioids increased four-fold between 1999 and 2010, prompting the FDA to classify the dramatic rise in abuse as an epidemic in 2012.
Purdue recently sponsored a series of four articles in The Atlantic, too, titled “A Delicate Balance,” which also discussed opioid abuse.
The Stamford, CT-based drugmaker cancelled a discussion with FDA advisers—the meeting had been scheduled for July—to discuss the results of postmarketing studies for the abuse-deterrent version of OxyContin. The studies evaluate whether that version of the painkiller lowered abuse rates.
Richard Fanelli, Purdue's head of regulatory affairs, said at the time that the company is conducting additional analyses before it plans to discuss the results.
A study conducted by the University of Washington and published in JAMA Psychiatry in May found that reformulated OxyContin was associated with a significant reduction of abuse when it was introduced to market—researchers attributed the reduction to users switching to other, more easily abused opioids—but they found that the reduction leveled off thereafter.
The study's authors surmised this was due to abusers transitioning from non-oral routes, such as injecting, to oral routes—such as smoking the drug—along with “successful efforts” by users in overcoming the drug's abuse-deterrent formulation.
“Until all the market has converted to opioids with some degree of recognized deterrence, we won't see the optimal impact,” Purdue's Haddox said. “Our impact will be maximal when the only opioid a person can get is abuse-deterrent.”
The final guidance for abuse-deterrent opioid evaluation and labeling was issued by the FDA in April. Congress had threatened to cut the agency's funding by $20 million if it failed to issue the report before the end of June.
The FDA on Friday approved OxyContin for children as young as 11 years old. The agency had asked Purdue to submit data on the drug's safety and efficacy in children as a way to better inform prescribing.