Acura Pharma rises on FDA OxyContin decision

Abuse-deterrent drug maker Acura rises as FDA limits OxyContin generics; citing abuse concerns

Associated Press

NEW YORK (AP) -- Shares of drug developer Acura Pharmaceuticals Inc. jumped more than 50 percent Wednesday after federal regulators moved to block new painkillers that aren't designed to resist abuse.

Acura makes drugs that are designed to be harder to abuse. The company sells a decongestant called Nexafed and its abuse-deterring technology is used in Pfizer Inc.'s painkiller Oxecta. Its stock jumped $1.14, or 53 percent, to $3.29 in afternoon trading. Earlier the stock was up 76 percent.

The Food and Drug Administration said Tuesday it will not approve any generic versions of OxyContin based on the original formulation because of its potential for abuse. A patent supporting the original form of the drug expired Tuesday, which would have opened the door for companies to start selling lower-cost versions. The FDA also approved labeling for newer versions of the drug that note those forms of the drug are designed to make OxyContin harder to abuse.

Purdue Pharmaceuticals LP stopped selling the original version of OxyContin in 2010, about 15 years after the drug was launched, because of widespread concern about people who were crushing the drug and injecting or snorting it to get high off its main ingredient, oxycodone. The ingredient is released over time if it's taken as intended, but people were able to get the high all at once by crushing or dissolving the tablet.

Purdue spent years developing a tamper-resistant version of the blockbuster pain pill, and regulators made it a priority to find alternatives that would be harder to abuse.

Oxecta is an immediate-release drug that contains oxycodone, the active ingredient in OxyContin. It uses Acura's Aversion technology to discourage abuse: if the drug is exposed to water or alcohol, the oxycodone becomes trapped in a gel mixture, making it difficult to get into a needle. If inhaled, it creates a burning, irritating sensation in the nose.

Nexafed contains pseudoephedrine, an ingredient in crystal meth. Acura says the drug contains inactive ingredients that turn into a thick gel if anyone tries to extract the pseudoephedrine. That means the chemical won't crystallize and can't be made into crystal meth.

Shares of Endo Health Solutions Inc. also traded higher on the news. William Blair & Co. analyst Tim Lugo said the FDA's decision could boost sales of Endo's drug Opana ER because the FDA will likely stop sales of a generic version of that drug — whose patent expires next month — because it's not tamper-resistant.

Endo stock gained 65 cents, or 2 percent, to $35.51.

Shares of Zogenix Inc. fell 11 cents, or 6.5 percent, to $1.57. Zogenix is developing a painkiller called Zohydro, and FDA advisers have recommended against approving the drug because of concerns it would contribute to prescription painkiller abuse. Lugo said Tuesday's announcement makes it less likely the FDA will approve Zohydro, the company's most advanced pipeline product.

Zohydro is designed to last longer than other severe pain drugs and, unlike many similar products, does not contain acetaminophen. That means patients would not be at risk for possible liver side effects.

Lugo rates both Endo and Zogenix shares "Outperform."

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