The U.S Food & Drug Administration (FDA) is set to reopen the debate concerning the rising abuse of opioid prescription painkillers next year. The agency will look to balance the risks of abuse and recreational use with the legitimate need of patients in serious pain.
The FDA has set a two-day public hearing to begin February 7, 2013. The agency has reportedly received comments, petitions and informational inquiries regarding the extent opioid prescription drugs should be used to manage pain. Regulators say the hearing will be used to educate doctors and healthcare providers in defining and measuring pain to limit opioid pain medication use.
Unfortunately, while recreational use of the drugs is on the rise, so is addiction of patients who need the drugs. It is these patients, who are prescribed initially for genuine pain management, that may be most at risk of addiction.
The plan for review of opioid medication comes in the wake of the FDA's denial of approval of a single-ingredient hydrocodone pill proposed by drugmaker Zogenix Inc. Although the company showed the drug was effective and filled a need in the market, the FDA panel recommended denying approval after hearing stories of addiction and subsequent death. The agency revealed that opioid pain medication are the most commonly prescribed drugs, and that there is a real need to limit their distribution.
Recently, there has been a push from the agency and public awareness groups to create tamper-resistant formulations of the pain medications to prevent the pills from being crushed and snorted for a faster and more intense high. The FDA intends to release guidelines on developing tamper-resistant formulations in January.
The FDA will decide by March if it will follow the panel's recommendation to deny Zogenix's pill that does not have a tamper-resistant formulation. Zogenix is currently researching a tamper-resistant formulation.
Also noteworthy to this debate, Endo Health Solutions Inc., which makes the Opana opioid pain medication, now makes an extended-release version of Opana that is tamper resistant and pulled its earlier form, which did not have the abuse deterrent formulation, off the market. Endo is now suing the FDA to force the agency to declare the earlier formulation is unsafe, to prevent generic manufacturers from producing it. However, Impax Laboratories Inc. is set to being manufacturing and selling a generic version of Opana without the tamper-resistant formulation in January. The FDA reports it will eventually work to find away to prevent non-tamper resistant generics to flood the market.