FDA encourages generic drugmakers to develop harder-to-abuse painkillers

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FDA encourages generic drugmakers to develop harder-to-abuse painkillers

FDA is encouraging industry to develop pain medicines "opioids" that are far more difficult to abuse. Abuse-deterrent characteristics make certain types of abuse, like as crushing a tablet in order to snort the drugs, or dissolving a capsule in order to inject it, more difficult. The U.S. officials are encouraging generic drugmakers to reformulate their painkillers to make them harder to abuse and take steps to redesign highly-addictive pain drugs like codeine and oxycodone.

Dr. Robert Califf, FDA Commissioner said, "By issuing the draft guidance, the FDA is helping to ensure that generic abuse-deterrent opioids are no less abuse deterrent than their brand-name counterparts." He added, "We hope that the availability of less costly generic products with abuse-deterrent properties has the potential to accelerate the shift away from the older products that do not include abuse-deterrent properties." To better understand the real-world impact of abuse-deterrent opioid formulations, the FDA  requires sponsors of brand-name products with approved abuse-deterrent labeling to conduct long- term studies to assess their effectiveness in reducing abuse in the real world. However, FDA recognized that these formulas are not effective and more research is warranted.

According to FDA, lower cost of these drugs allows  to access such drugs with abuse-deterrent properties and it is one of the  important step toward reducing narcotic abuse while helping to "ensure access to appropriate treatment for patients in pain."

The draft guidance includes recommendations to industry about the studies needed to show that a generic opioid is no less abuse-deterrent than the brand-name drug, with respect to all potential routes of abuse. FDA announced for feedback from the generic drug industry during a 60-day comment period. Additionally, certain opioid drugs such as Oxycontin, Percocet and Vicodin will get new "boxed warnings" about the dangers of misuse and Centers for Disease Control and Prevention also announced new recommendations for doctors who prescribe these drugs.

CDC advisory urged doctors to avoid prescribing powerful opiate painkillers for patients with chronic pain such as joint or back pain, dental pain (tooth extraction, for example), or other chronic pain treated in an outpatient setting. CDC also conveyed that it would not include the use of narcotic painkillers for those people dealing with cancer-related pain or at last stage of life. In 2014, around 47,000 Americans lost their lives due to drug overdose, a 14 percent jump from the previous year.

Regulatory, FDA, Generic, Painkillers, CDC advisory
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