Opana ER Looking At REMS – Or Worse – After US FDA Panel Weighs Intravenous Abuse Risk
Most advisory committee members say Endo’s reformulated long-acting opioid no longer has a favorable risk/benefit profile due to increased intravenous abuse; panelists split on whether drug should be taken off market or if restrictive REMS would suffice.
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Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.
Studies showing oxycodone could be extracted for intravenous use troubled advisory committee members, who worried it would result in the same types of adverse public health effects that led to market withdrawal of Endo’s Opana ER; panelists also were concerned about the ability to partially defeat Remoxy’s extended-release properties by chewing the product.
Company will cease manufacturing the extended-release oxymorphone formulation immediately and will not ship existing finished product after Sept. 1; decision to pull the opioid from the market heads off a fight with FDA, which sought withdrawal due intravenous abuse liability.