Sábado, 21 Abril, 2018

FDA Panel: Opana ER Painkiller Poses More Risks Than Benefits

How Endo's FDA Decision Affects Egalet Risks of Endo's opioid painkiller outweigh benefits: FDA panel
Cris De Lacerda | 17 Marcha, 2017, 01:38

A panel of advisers to FDA concluded Tuesday that the benefits of an opioid analgesic linked to a 2015 HIV outbreak in the IN no longer outweigh the risks.

However, data shows that while nasal abuse has reduced with the reformulation, rates of intravenous abuse increased, FDA staff noted in their review on Thursday, acknowledging that it was unclear whether that rise was tied directly to the reformulation. The risks are related to its use as an abused drug.

Initially approved in 2006, a new formulation of Opana ER created to deter abuse hit the market in 2012.

Endo's shares closed down about 4 percent and were down about 1.7 percent in extended trading.

The Centers for Disease Control and Prevention has said that opioid abuse via prescription painkillers as well as heroin as well as other drugs has climbed steeply in recent years and now estimates that as many as 91 Americans overdose each day. Eight members disagreed with the majority and one member abstained in the vote regarding the drug.

The FDA usually follows panel recommendations, but it is not required to do so.

Panelists expressed concerns that the voting question posed to them did not expect them to evaluate the risk-benefit profile for the intended user, versus an addict. It could choose to change the product's labeling, restrict prescribing and/or remove it from the market altogether.

Panelist Ronald Litman pointed out that if oxymorphones - generics in the same class - remain on the market in any form, Opana ER could benefit patients because of its abuse-deterrent properties, according to Reuters.