FDA更新羟考酮新剂型的说明书

　　2013年4月16日，美国食品与药物管理局（FDA）批准了奥施康定（通用名：盐酸羟考酮控释片）新剂型说明书的更新。更改后的说明书显示，因该药可能会导致滥用，为减少滥用可通过嗅吸法途径给药。

　　另外，与奥施康定的新剂型相比，原来的盐酸羟考酮控释片有同样的治疗获益，但其获益未超出药物滥用风险，因此FDA决定撤出其销售权，同时FDA将不接受或批准任何原来的盐酸羟考酮控释片的非专利简化新药申请。

　　FDA于1995年12月批准了原来的盐酸羟考酮控释片，该药的滥用问题可能增加严重不良反应危险。2010年4月，FDA批准了羟考酮的新剂型，这种剂型不易滥用或误用。FDA药物评价与研究中心相关负责人表示，无论是原来的奥施康定还是新剂型都有可能滥用或误用，FDA预测，那些有注射困难的人群可能会滥用羟考酮的新剂型，与原来的奥施康定相比，新剂型可通过嗅吸法减少滥用。

　　新剂型的羟考酮难于碾碎、掰开或溶解，它由粘稠的凝胶构成而难用于注射，但通过这些途径的滥用和口服的滥用仍有可能。    

原文阅读：FDA approves abuse-deterrent labeling for reformulated OxyContin
Agency will not approve generics to original OxyContin
The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).
Additionally, because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.
The FDA approved the original formulation of OxyContin in Dec. 1995. The product was abused, often following manipulation intended to defeat its extended-release properties. Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death. In April 2010, the FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for purposes of misuse or abuse. Purdue stopped shipping original OxyContin to pharmacies in August 2010.
“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”
The FDA has determined that the reformulated product has abuse-deterrent properties. The tablet is more difficult to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The agency has determined that the physical and chemical properties of the reformulated product are expected to make the product difficult to inject and to reduce abuse via snorting. However, abuse of OxyContin by these routes, as well as the oral route, is still possible. The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube. When FDA finds that a new formulation has abuse deterrent properties, the agency has the authority to require generics to have abuse-deterrent properties also.
The agency review of this issue included an analysis of the following:
Citizen petitions requesting that the agency determine whether original OxyContin was voluntarily withdrawn from sale for reasons other than safety or effectiveness;
Comments submitted to the public dockets associated with these petitions;
Information concerning original and reformulated OxyContin and the withdrawal of original OxyContin;
Clinical data, peer-reviewed literature, and other information concerning postmarketing adverse events associated with original OxyContin, reformulated OxyContin, and other extended-release oxycodone products.
Postmarketing assessments of the impact of reformulated OxyContin on abuse are ongoing, and the FDA will update its evaluation of the effects of reformulated OxyContin on abuse as new data become available.
The FDA, together with other public health agencies, continues to encourage the development of abuse-deterrent formulations of opioids and believes that such products will help reduce prescription drug abuse. At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics.
For more information:
Federal Register Notice1
FDA Actions on OxyContin Products2
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.