FDA Approves Purdue Pharma’s Abuse-Deterrent Painkiller
The FDA approved only the second extended-release opioid painkiller to feature abuse-deterrent properties, and hinted that future products with such technologies could receive faster regulatory reviews.
Purdue Pharma’s Targiniq ER (oxycodone HCl and naloxone HCl extended-release tablets) was approved to treat severe pain that requires daily care and where alternative treatments aren’t enough, the FDA said in a press release.
The drug’s inclusion of naloxone is designed to deter abuse, the agency said.
“When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone,” the FDA said. “Targiniq ER can still be abused, including when taken orally, which is currently the most common way oxycodone is abused.”
The FDA has asked the Stamford, Conn., drugmaker to conduct postmarket studies on Targiniq’s abuse potential and the effects of the abuse-deterrent features, a new requirement for all manufacturers of extended-release/long-acting opioids. The only other extended-release formulation is Purdue Pharma’s blockbuster Oxycontin (oxycodone HCl).
The agency is actively encouraging drugmakers to pursue abuse-deterrent formulations in their painkillers, and may grant priority review status or use other expedited pathways for such products, spokeswoman Morgan Liscinsky said.
In addition, the FDA has said it might support longer market exclusivity for products that use packaging, storage and disposal systems or technologies to thwart abusers.
The enticements come as the FDA continues to take heat from lawmakers for approving Zogenix’s Zohydro ER (hydrocodone bitrate) last fall. The single-entity hydrocodone painkiller was approved without abuse-deterrent technology and over objections from FDA advisors. Various lawmakers contend that Zohydro is a prime target for abuse.
In the FDA’s fiscal 2015 funding package, House appropriators took the unusual step of withholding $20 million in funds until the agency finalizes January 2013 guidance on abuse-deterrent opioids. — Robert King
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.