×

Our award-winning reporting has moved

Context provides news and analysis on three of the world’s most critical issues:

climate change, the impact of technology on society, and inclusive economies.

Pfizer, Acura abuse-resistant painkiller gets FDA nod

by Reuters
Monday, 20 June 2011 16:10 GMT

* Says drug designed to deter abuse by injection or snorting

* Drug could decrease abuse of popular painkiller oxycodone

* Acura shares up 28 percent (Adds details on drug, updates share movement)

By Shravya Jain

BANGALORE, June 20 (Reuters) - Pfizer Inc and Acura Pharmaceuticals Inc said U.S. health regulators approved their pain drug, designed to combat the widespread abuse of opioid-based painkillers, sending Acura's shares up by nearly a third.

The tablet, Oxecta, was approved by the U.S. Food and Drug Administration for the treatment of acute and chronic moderate to severe pain in cases where use of an opioid painkiller is suitable.

The drug's active ingredient is the popular painkiller oxycodone -- called "Hillbilly heroin" or "poor man's heroin" -- a narcotic derived from morphine that has resulted in its rampant abuse.

Between 2002 and 2009, the number of Americans aged 12 and older abusing pain relievers increased by 20 percent, according to the Substance Abuse and Mental Health Services Administration, which said unintentional drug overdose was the leading cause of injury death in 17 states.

In April, the Obama administration unveiled a plan to fight what it called a prescription drug abuse epidemic that aims for a 15 percent reduction over five years in non-medical use of prescription-type psychotherapeutic drugs.

Citigroup analyst John Boris said in a note to clients that he expects Oxecta's abuse resistant technology to provide an incremental opportunity for Pfizer, estimating peak sales of about ${esc.dollar}100 million for the drug.

Oxecta uses Acura's Aversion technology, which deters abuse by intravenous injection or nasal snorting, Acura Chief Financial Officer Peter Clemens told Reuters by phone.

If crushed and snorted, the drug discourages abuse by burning and irritating the nasal passage. If dissolved in water, alcohol or other solvent, the drug turns into a gel, making it difficult to draw through an intravenous needle.

But a third method to discourage oral abuse was not included in the drug.

The companies dropped that provision in Oxecta after an FDA advisory panel rejected an earlier version of the drug, Acurox, last year, on insufficient data to show that addition of the vitamin niacin would deter excess oral intake.

In a regulatory filing, Acura said the FDA asked Pfizer to conduct a post-approval study to determine whether Oxecta usage resulted in a decrease in the consequences of misuse and abuse.

Pfizer, which will pay Acura ${esc.dollar}20 million in milestones, acquired rights to the drug when it bought King Pharmaceuticals in January.

"Pfizer has indicated that it plans to launch the drug in the third quarter," Acura's CFO said.

Acura's stock jumped as much as 75 percent to a year-high of ${esc.dollar}6.80. It was up 27 percent at ${esc.dollar}4.90 in mid-day trade, making it one of the top percentage gainers on Monday on Nasdaq.

Pfizer shares were down slightly at ${esc.dollar}20.22 on the New York Stock Exchange. (Reporting by Shravya Jain in Bangalore; Editing by Roshni Menon and Anthony Kurian)

Our Standards: The Thomson Reuters Trust Principles.


-->