Pfizer Inc. (NYSE:PFE) Troxyca ER Receives FDA Panel Approval

Pfizer Inc. (NYSE:PFE) painkiller drug Troxyca ER has received the backing of an FDA advisory panel for marketing approval. Looking at the voting pattern, though, it was a divided house trying to decide which way for the opioid painkiller.

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One of the major divisive issues was whether the drug deterred all forms of potential abuse. The panel voted 9-6 to recommend that the FDA approves the product however. While the FDA has typically followed the recommendations of its advisory panels, it has room to take a different path.

Fisher Asset Management is currently the hedge fund with the largest position in Pfizer at 31.75 million shares.

The FDA panel recommended approval of Pfizer’s Troxyca ER on the basis that it does dull pain effectively. The panelists also noted that the drug is designed in such a way that it could curb abuse, but not in every conceivable way. For example, while the panel agreed that Troxyca ER could deter addicts from snorting or injecting, they voted against Pfizer’s claim that the drug could also deter oral abuse.

Chemical composition of the drug

Pfizer’s Troxyca ER contains naltrexone and oxycodone. The purpose of naltrexone in the compound is to cancel the effect of oxycodone if the drug is not taken in the recommended way. But when it is taken as recommended, naltrexone doesn’t diminish the effect of oxycodone, which is what the active pain relief ingredient.

The availability of naltrexone and oxycodone makes it difficult for addicts to crush the pellets in order to release oxycodone so that they can get high quickly. If anyone attempts to crush the pellets, they will end up with naltrexone and oxycodone in the crushed powder and there will be no high effect.

Nevertheless, the panel appeared to be concerned that addicts could still use certain solvents in order to only extract oxycodone from the compound while keeping away the neutralizer naltrexone. If that happens, the panel worried that oral abuse of Pfizer’s Troxyca ER would be possible.

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